Trial Outcomes & Findings for A Phase I/Ib Safety and Efficacy Study of the PI3K-delta Inhibitor TGR-1202 and Ibrutinib in Patients With CLL or MCL (NCT NCT02268851)

Last Updated: 2024-11-15

Results Overview

To assess the safety of TGR1202 in combination with ibrutinib relapsed or refractory CLL or MCL. DLT is based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. DLT refers to toxicities experienced at any time during the study treatment, defined as Grade 4 anemia; Grade 4 neutropenia lasting \>7 days (while receiving growth factor support); Grade 4 thrombocytopenia lasting \> 7 days; Grade ≥3 febrile neutropenia; and Grade ≥3 thrombocytopenia with Grade \>2 hemorrhage;Grade ≥ 3 non-hematologic toxicity unresponsive to standard supportive care measure with the exception of asymptomatic Grade ≥3 lab abnormalities that resolve to ≤ Grade 1 or baseline within 7 days;treatment delay of ≥14 days due to unresolved toxicity; and non-hematologic toxicity of Grade 2 (at any time during treatment) that, in the judgment of the Investigators, Study Chair, and the Medical Monitor, is dose-limiting.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

45 participants

Primary outcome timeframe

Participants were assessed every week or more often as needed during Cycle 1 or more often for up to 28 days to assess Dose-limiting toxicities (DLTs) during Phase I

Results posted on

2024-11-15

Participant Flow

Participants in the Phase I portion of the study enrolled in outpatient clinic setting from 11/20/2014 to 12/22/2018 and to the Phase II study from 1/14/2016 to 5/29/2018. The MCL and CLL arms were enrolled independently of each other, and were allowed to begin enrolling to the protocol scheduled expansion independent of the other arm.

Participant milestones

Participant milestones
Measure	CLL: Phase I Cohort 1 Phase I Cohort 1 patients received oral agent TGR1202 400mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.	MCL: Phase I Cohort 1 Phase I Cohort 1 patients received oral agent TGR1202 400mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 560 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.	CLL: Phase I Cohort 2 Phase I Cohort 2 patients received oral agent TGR1202 600mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.	MCL: Phase I Cohort 2 Phase I Cohort 2 patients received oral agent TGR1202 600mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.	CLL: Phase I/II Cohort 3 (RPD2) Phase I Cohort 3 patients received oral agent TGR1202 800mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.	MCL: Phase I/II Cohort 3 (RPD2) Phase I Cohort 3 patients received oral agent TGR1202 800mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.
Overall Study STARTED	3	3	4	3	15	15
Overall Study COMPLETED	2	0	3	0	8	4
Overall Study NOT COMPLETED	1	3	1	3	7	11

Reasons for withdrawal

Reasons for withdrawal
Measure	CLL: Phase I Cohort 1 Phase I Cohort 1 patients received oral agent TGR1202 400mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.	MCL: Phase I Cohort 1 Phase I Cohort 1 patients received oral agent TGR1202 400mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 560 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.	CLL: Phase I Cohort 2 Phase I Cohort 2 patients received oral agent TGR1202 600mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.	MCL: Phase I Cohort 2 Phase I Cohort 2 patients received oral agent TGR1202 600mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.	CLL: Phase I/II Cohort 3 (RPD2) Phase I Cohort 3 patients received oral agent TGR1202 800mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.	MCL: Phase I/II Cohort 3 (RPD2) Phase I Cohort 3 patients received oral agent TGR1202 800mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.
Overall Study Death	0	0	0	1	2	1
Overall Study Adverse Event	0	0	0	0	2	2
Overall Study Withdrawal by Subject	0	0	0	2	0	1
Overall Study Progressive Disease	1	3	0	0	1	4
Overall Study Physician Decision	0	0	1	0	0	1
Overall Study Patient Compliance	0	0	0	0	1	1
Overall Study Co-Morbid Condition	0	0	0	0	1	1

Baseline Characteristics

A Phase I/Ib Safety and Efficacy Study of the PI3K-delta Inhibitor TGR-1202 and Ibrutinib in Patients With CLL or MCL

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CLL: Phase I Cohort 1 n=3 Participants Phase I Cohort 1 patients received oral agent TGR1202 400mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.	MCL: Phase 1 Cohort 1 n=3 Participants Phase I Cohort 1 patients received oral agent TGR1202 400mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 560 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.	CLL: Phase I Cohort 2 n=4 Participants Phase I Cohort 2 patients received oral agent TGR1202 600mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.	MCL: Phase I Cohort 2 n=3 Participants Phase I Cohort 2 patients received oral agent TGR1202 600mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 560 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.	CLL Phase I/IICohort 3 (RPD2) n=15 Participants Phase I Cohort 3 patients received oral agent TGR1202 800mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.	MCL Phase I/II Cohort 3 (RPD2) n=15 Participants Phase I Cohort 3 patients received oral agent TGR1202 800mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 560 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.	Total n=43 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	3 Participants n=10 Participants	12 Participants n=115 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	13 Participants n=21 Participants	12 Participants n=10 Participants	31 Participants n=115 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	5 Participants n=21 Participants	5 Participants n=10 Participants	17 Participants n=115 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	10 Participants n=21 Participants	10 Participants n=10 Participants	26 Participants n=115 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	2 Participants n=4 Participants	15 Participants n=21 Participants	15 Participants n=10 Participants	41 Participants n=115 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Region of Enrollment United States	3 participants n=5 Participants	3 participants n=7 Participants	4 participants n=5 Participants	3 participants n=4 Participants	15 participants n=21 Participants	15 participants n=10 Participants	43 participants n=115 Participants

PRIMARY outcome

Timeframe: Participants were assessed every week or more often as needed during Cycle 1 or more often for up to 28 days to assess Dose-limiting toxicities (DLTs) during Phase I

Population: Patients who have been previously treated for MCL, CLL or SLL. MCL must have 1 measurable site of disease and have had received at least one prior standard therapy; CLL/SLL patients must have an indication for treatment according to 2008 ICWLL criteria and received at least one prior standard treatment regimen

Outcome measures

Outcome measures
Measure	MCL Cohort n=3 Participants Dose escalation will occur using a standard 3+3 dose escalation approach, beginning in dose level I with dose cohorts and rules for escalation and de-escalation. * Each Cycle = 28 days * TGR-1202 (oral): Starting on Day 1 administered daily. * Ibrutinib (oral): Starting on Day 1 administered daily.	CLL Cohort n=3 Participants Dose escalation will occur using a standard 3+3 dose escalation approach, beginning in dose level I with dose cohorts and rules for escalation and de-escalation. * Each Cycle = 28 days * TGR-1202 (oral): Starting on Day 1 administered daily. * Ibrutinib (oral): Starting on Day 1 administered daily.	CLL: Phase I Cohort 2 n=3 Participants Phase I Cohort 2 patients received oral agent TGR1202 600mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.	MCL: Phase I Cohort 2 n=3 Participants Phase I Cohort 2 patients received oral agent TGR1202 600mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.	CLL Phase I/IICohort 3 (RPD2) n=15 Participants Phase I Cohort 3 patients received oral agent TGR1202 800mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.	MCL Phase I/II Cohort 3 (RPD2) n=15 Participants Phase I Cohort 3 patients received oral agent TGR1202 800mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.
Number of Patients Who Experienced a Dose Limiting Toxicity (DLT) During Phase I	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: At baseline, End of Cycle 2, End of Cycle 5, End of Cycle 9, End of Cycle 14 and approximately q6 months until C26, then investigator discretion thereafter

Population: all the patients were pooled together from ph1 and ph1b for the final efficacy analysis

The overall response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) based on the 2008 IW-CLL criteria for CLL (Hallek et al., 2008) by Lugano Criteria ( Cheson et al,.24) for MCL.

Outcome measures

Outcome measures
Measure	MCL Cohort n=21 Participants Dose escalation will occur using a standard 3+3 dose escalation approach, beginning in dose level I with dose cohorts and rules for escalation and de-escalation. * Each Cycle = 28 days * TGR-1202 (oral): Starting on Day 1 administered daily. * Ibrutinib (oral): Starting on Day 1 administered daily.	CLL Cohort n=21 Participants Dose escalation will occur using a standard 3+3 dose escalation approach, beginning in dose level I with dose cohorts and rules for escalation and de-escalation. * Each Cycle = 28 days * TGR-1202 (oral): Starting on Day 1 administered daily. * Ibrutinib (oral): Starting on Day 1 administered daily.	CLL: Phase I Cohort 2 Phase I Cohort 2 patients received oral agent TGR1202 600mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.	MCL: Phase I Cohort 2 Phase I Cohort 2 patients received oral agent TGR1202 600mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.	CLL Phase I/IICohort 3 (RPD2) Phase I Cohort 3 patients received oral agent TGR1202 800mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.	MCL Phase I/II Cohort 3 (RPD2) Phase I Cohort 3 patients received oral agent TGR1202 800mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.
Overall Response Rate (ORR)	71.4 percentage of participants Interval 39.98 to 100.0	95.2 percentage of participants Interval 58.17 to 100.0	—	—	—	—

SECONDARY outcome

Timeframe: At baseline, End of Cycle 2, End of Cycle 5, End of Cycle 9, End of Cycle 14 and approximately q6 months until C26, then investigator discretion thereafter

Population: all the patients were pooled together from ph1 and ph1b for the final efficacy analysis

nPR will only be evaluated in CLL patients, defined as percentage of patients achieved nodal PR. As per Cheson et al., 2012, patients who achieve a radiographic PR but continue to have a lymphocytosis with \>5,000 B-lymphocytes per μL are considered to have a nodular partial response, also known as PR with lymphocytosis, due to the fact that they appear to derive a similar clinical benefit from BCR inhibitors as patients who achieve a traditional PR.

Outcome measures

Outcome measures
Measure	MCL Cohort Dose escalation will occur using a standard 3+3 dose escalation approach, beginning in dose level I with dose cohorts and rules for escalation and de-escalation. * Each Cycle = 28 days * TGR-1202 (oral): Starting on Day 1 administered daily. * Ibrutinib (oral): Starting on Day 1 administered daily.	CLL Cohort n=21 Participants Dose escalation will occur using a standard 3+3 dose escalation approach, beginning in dose level I with dose cohorts and rules for escalation and de-escalation. * Each Cycle = 28 days * TGR-1202 (oral): Starting on Day 1 administered daily. * Ibrutinib (oral): Starting on Day 1 administered daily.	CLL: Phase I Cohort 2 Phase I Cohort 2 patients received oral agent TGR1202 600mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.	MCL: Phase I Cohort 2 Phase I Cohort 2 patients received oral agent TGR1202 600mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.	CLL Phase I/IICohort 3 (RPD2) Phase I Cohort 3 patients received oral agent TGR1202 800mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.	MCL Phase I/II Cohort 3 (RPD2) Phase I Cohort 3 patients received oral agent TGR1202 800mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.
Rate of Nodal Partial Response With Lymphocytosis (nPR)	—	71.4 percentage of patients	—	—	—	—

SECONDARY outcome

Timeframe: Disease will be evaluated at baseline, cycle 1 day 1,8,15,22 and cycle 2 day 1,15, and cycle 3-6 on day1, and every 2 cycles until cycle 12, then every 3 cycles thereafter. In long-term follow-up, survival will be followed every 3 cycles up to 2 years.

Population: all the patients were pooled together from ph1 and ph1b for the final efficacy analysis

Progression-free survival based on the Kaplan-Meier method is defined as the duration between randomization and documented disease progression (PD) or death, or is censored at time of last dsease assessment.

Outcome measures

Outcome measures
Measure	MCL Cohort n=21 Participants Dose escalation will occur using a standard 3+3 dose escalation approach, beginning in dose level I with dose cohorts and rules for escalation and de-escalation. * Each Cycle = 28 days * TGR-1202 (oral): Starting on Day 1 administered daily. * Ibrutinib (oral): Starting on Day 1 administered daily.	CLL Cohort n=21 Participants Dose escalation will occur using a standard 3+3 dose escalation approach, beginning in dose level I with dose cohorts and rules for escalation and de-escalation. * Each Cycle = 28 days * TGR-1202 (oral): Starting on Day 1 administered daily. * Ibrutinib (oral): Starting on Day 1 administered daily.	CLL: Phase I Cohort 2 Phase I Cohort 2 patients received oral agent TGR1202 600mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.	MCL: Phase I Cohort 2 Phase I Cohort 2 patients received oral agent TGR1202 600mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.	CLL Phase I/IICohort 3 (RPD2) Phase I Cohort 3 patients received oral agent TGR1202 800mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.	MCL Phase I/II Cohort 3 (RPD2) Phase I Cohort 3 patients received oral agent TGR1202 800mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.
Median Progression-Free Survival (PFS)	26.87 months Interval 10.09 to Upper limit not statistically reachable using KM	82.66 months Interval 55.23 to Upper limit not statistically reachable using KM	—	—	—	—

SECONDARY outcome

Timeframe: Disease response will be evaluated at baseline, cycle 1 day 1,8,15,22 and cycle 2 day 1,15, and cycle 3-6 on day1, and every 2 cycles until cycle 12, then every 3 cycles thereafter.

Population: all the patients were pooled together from ph1 and ph1b for the final efficacy analysis

Duration of Overall Response (DOR), estimated using the Kaplan Meier method, is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) per 2008 IWCLL Criteria, until the first date that recurrent or progressive disease is objectively documented. Patients without progressive disease are censored at the date of last disease assessment.

Outcome measures

Outcome measures
Measure	MCL Cohort n=21 Participants Dose escalation will occur using a standard 3+3 dose escalation approach, beginning in dose level I with dose cohorts and rules for escalation and de-escalation. * Each Cycle = 28 days * TGR-1202 (oral): Starting on Day 1 administered daily. * Ibrutinib (oral): Starting on Day 1 administered daily.	CLL Cohort n=21 Participants Dose escalation will occur using a standard 3+3 dose escalation approach, beginning in dose level I with dose cohorts and rules for escalation and de-escalation. * Each Cycle = 28 days * TGR-1202 (oral): Starting on Day 1 administered daily. * Ibrutinib (oral): Starting on Day 1 administered daily.	CLL: Phase I Cohort 2 Phase I Cohort 2 patients received oral agent TGR1202 600mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.	MCL: Phase I Cohort 2 Phase I Cohort 2 patients received oral agent TGR1202 600mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.	CLL Phase I/IICohort 3 (RPD2) Phase I Cohort 3 patients received oral agent TGR1202 800mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.	MCL Phase I/II Cohort 3 (RPD2) Phase I Cohort 3 patients received oral agent TGR1202 800mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.
Median Duration of Overall Response (DOR)	42.32 months Interval 9.17 to Upper limit not statistically reachable using KM	80.36 months Interval 46.42 to Upper limit not statistically reachable using KM	—	—	—	—

Adverse Events

CLL: Phase I Cohort 1

Serious events: 2 serious events

Other events: 3 other events

Deaths: 1 deaths

MCL: Phase I Cohort 1

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 deaths

CLL: Phase I Cohort 2

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

MCL: Phase I Cohort 2

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 deaths

CLL: Phase I/IICohort 3 (RPD2)

Serious events: 3 serious events

Other events: 15 other events

Deaths: 2 deaths

MCL: Phase I/II Cohort 3 (RPD2)

Serious events: 5 serious events

Other events: 15 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	CLL: Phase I Cohort 1 n=3 participants at risk Phase I Cohort 1 patients received oral agent TGR1202 400mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.	MCL: Phase I Cohort 1 n=3 participants at risk Phase I Cohort 1 patients received oral agent TGR1202 400mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 560 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.	CLL: Phase I Cohort 2 n=4 participants at risk Phase I Cohort 2 patients received oral agent TGR1202 600mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.	MCL: Phase I Cohort 2 n=3 participants at risk Phase I Cohort 2 patients received oral agent TGR1202 600mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.	CLL: Phase I/IICohort 3 (RPD2) n=15 participants at risk Phase I Cohort 3 patients received oral agent TGR1202 800mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.	MCL: Phase I/II Cohort 3 (RPD2) n=15 participants at risk Phase I Cohort 3 patients received oral agent TGR1202 800mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.
Infections and infestations Sepsis	33.3% 1/3 • Number of events 1 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Disease Progression	33.3% 1/3 • Number of events 1 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 1/3 • Number of events 1 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 1/3 • Number of events 1 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	13.3% 2/15 • Number of events 2 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	13.3% 2/15 • Number of events 2 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Cardiac disorders Supraventricular Tachycardia	33.3% 1/3 • Number of events 1 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
General disorders Sudden Death	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	6.7% 1/15 • Number of events 1 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	6.7% 1/15 • Number of events 1 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Infections and infestations Paraspinal Infection	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	6.7% 1/15 • Number of events 1 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Infections and infestations Fungal Pneumonia	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	6.7% 1/15 • Number of events 1 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Infections and infestations Cellulitis	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	6.7% 1/15 • Number of events 1 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.

Other adverse events

Other adverse events
Measure	CLL: Phase I Cohort 1 n=3 participants at risk Phase I Cohort 1 patients received oral agent TGR1202 400mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.	MCL: Phase I Cohort 1 n=3 participants at risk Phase I Cohort 1 patients received oral agent TGR1202 400mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 560 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.	CLL: Phase I Cohort 2 n=4 participants at risk Phase I Cohort 2 patients received oral agent TGR1202 600mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.	MCL: Phase I Cohort 2 n=3 participants at risk Phase I Cohort 2 patients received oral agent TGR1202 600mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.	CLL: Phase I/IICohort 3 (RPD2) n=15 participants at risk Phase I Cohort 3 patients received oral agent TGR1202 800mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.	MCL: Phase I/II Cohort 3 (RPD2) n=15 participants at risk Phase I Cohort 3 patients received oral agent TGR1202 800mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities.
Gastrointestinal disorders Abdominal pain	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	25.0% 1/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	6.7% 1/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	13.3% 2/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Investigations Alanine aminotransferase increased	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	13.3% 2/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	20.0% 3/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Investigations Alkaline phosphatase increased	66.7% 2/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	75.0% 3/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	6.7% 1/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	13.3% 2/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Skin and subcutaneous tissue disorders Alopecia	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	25.0% 1/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	6.7% 1/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Blood and lymphatic system disorders Anemia	66.7% 2/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	100.0% 3/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	75.0% 3/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	66.7% 2/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	100.0% 15/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	46.7% 7/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Metabolism and nutrition disorders Anorexia	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	100.0% 3/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	26.7% 4/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	13.3% 2/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Psychiatric disorders Anxiety	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	25.0% 1/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	20.0% 3/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Musculoskeletal and connective tissue disorders Arthralgia	66.7% 2/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	25.0% 1/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	20.0% 3/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	6.7% 1/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Musculoskeletal and connective tissue disorders Arthritis	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	13.3% 2/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Investigations Aspartate aminotransferase increased	100.0% 3/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	66.7% 2/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	25.0% 1/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	66.7% 2/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	46.7% 7/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 5/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Cardiac disorders Atrial fibrillation	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	25.0% 1/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	20.0% 3/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	6.7% 1/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Musculoskeletal and connective tissue disorders Back pain	100.0% 3/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	25.0% 1/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 5/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	20.0% 3/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Gastrointestinal disorders Bloating	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	25.0% 1/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	6.7% 1/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	13.3% 2/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Investigations Blood bilirubin increased	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	50.0% 2/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	20.0% 3/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	26.7% 4/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Eye disorders Blurred vision	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	25.0% 1/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	20.0% 3/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	6.7% 1/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Injury, poisoning and procedural complications Bruising	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	66.7% 2/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	25.0% 1/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	60.0% 9/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	46.7% 7/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Gastrointestinal disorders Colitis	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	13.3% 2/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Psychiatric disorders Confusion	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	25.0% 1/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	13.3% 2/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	26.7% 4/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Gastrointestinal disorders Constipation	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	25.0% 1/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	26.7% 4/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	26.7% 4/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Respiratory, thoracic and mediastinal disorders Cough	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	50.0% 2/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	46.7% 7/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	20.0% 3/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Investigations Creatinine increased	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	25.0% 1/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 5/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	20.0% 3/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Metabolism and nutrition disorders Dehydration	66.7% 2/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	6.7% 1/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	6.7% 1/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Gastrointestinal disorders Diarrhea	66.7% 2/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	100.0% 3/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	50.0% 2/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	100.0% 3/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	66.7% 10/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	80.0% 12/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Nervous system disorders Dizziness	66.7% 2/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	50.0% 2/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	66.7% 2/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	40.0% 6/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	26.7% 4/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	25.0% 1/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	6.7% 1/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	13.3% 2/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Nervous system disorders Dysgeusia	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	13.3% 2/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	6.7% 1/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Gastrointestinal disorders Dyspepsia	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	25.0% 1/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	6.7% 1/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	13.3% 2/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	50.0% 2/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 5/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	26.7% 4/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
General disorders Edema limbs	66.7% 2/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	50.0% 2/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	20.0% 3/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	20.0% 3/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Respiratory, thoracic and mediastinal disorders Epistaxis	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	13.3% 2/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Injury, poisoning and procedural complications Fall	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	20.0% 3/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	13.3% 2/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
General disorders Fatigue	100.0% 3/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	66.7% 2/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	75.0% 3/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	100.0% 3/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	80.0% 12/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	86.7% 13/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
General disorders Fever	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	25.0% 1/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	6.7% 1/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	13.3% 2/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Gastrointestinal disorders Flatulence	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	25.0% 1/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	6.7% 1/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Gastrointestinal disorders Gastroesophageal reflux disease	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	100.0% 3/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	13.3% 2/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 5/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	6.7% 1/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	20.0% 3/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	25.0% 1/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	13.3% 2/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	13.3% 2/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Nervous system disorders Headache	66.7% 2/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	66.7% 2/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	50.0% 2/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	26.7% 4/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	40.0% 6/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Ear and labyrinth disorders Hearing impaired	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	13.3% 2/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	6.7% 1/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Vascular disorders Hematoma	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	25.0% 1/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	26.7% 4/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Metabolism and nutrition disorders Hyperglycemia	100.0% 3/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	50.0% 2/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	100.0% 3/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	93.3% 14/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	46.7% 7/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Skin and subcutaneous tissue disorders Hyperhidrosis	100.0% 3/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	50.0% 2/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	20.0% 3/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	6.7% 1/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	25.0% 1/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	6.7% 1/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	20.0% 3/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Vascular disorders Hypertension	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	50.0% 2/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	20.0% 3/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 5/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Metabolism and nutrition disorders Hyperuricemia	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	20.0% 3/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	13.3% 2/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Metabolism and nutrition disorders Hypoalbuminemia	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	50.0% 2/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	100.0% 3/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	26.7% 4/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	26.7% 4/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Metabolism and nutrition disorders Hypocalcemia	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	66.7% 2/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	50.0% 2/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	66.7% 2/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	46.7% 7/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 5/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Metabolism and nutrition disorders Hypoglycemia	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	66.7% 2/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	66.7% 2/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	40.0% 6/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	26.7% 4/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	50.0% 2/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	20.0% 3/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	53.3% 8/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Metabolism and nutrition disorders Hypomagnesemia	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	13.3% 2/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	40.0% 6/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Metabolism and nutrition disorders Hyponatremia	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	75.0% 3/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	100.0% 3/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 5/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	40.0% 6/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Metabolism and nutrition disorders Hypophosphatemia	66.7% 2/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	25.0% 1/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	20.0% 3/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	40.0% 6/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Vascular disorders Hypotension	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	25.0% 1/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	6.7% 1/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	6.7% 1/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Infections and infestations Infections and infestations - Other, specify	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	75.0% 3/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	6.7% 1/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	6.7% 1/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Psychiatric disorders Insomnia	66.7% 2/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	25.0% 1/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	20.0% 3/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	26.7% 4/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Blood and lymphatic system disorders Leukocytosis	66.7% 2/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 5/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Gastrointestinal disorders Lip pain	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	13.3% 2/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	6.7% 1/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Investigations Lipase increased	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	25.0% 1/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	6.7% 1/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	6.7% 1/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
General disorders Localized edema	66.7% 2/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	25.0% 1/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	6.7% 1/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	20.0% 3/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Infections and infestations Lung infection	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	50.0% 2/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 5/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	26.7% 4/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Investigations Lymphocyte count decreased	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	50.0% 2/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	6.7% 1/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	40.0% 6/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Investigations Lymphocyte count increased	100.0% 3/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	66.7% 2/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	50.0% 2/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	73.3% 11/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	13.3% 2/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
General disorders Malaise	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	13.3% 2/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	6.7% 1/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Nervous system disorders Memory impairment	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	25.0% 1/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	6.7% 1/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	13.3% 2/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Gastrointestinal disorders Mucositis oral	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	25.0% 1/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	6.7% 1/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	13.3% 2/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	25.0% 1/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	6.7% 1/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	13.3% 2/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Musculoskeletal and connective tissue disorders Myalgia	66.7% 2/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	66.7% 2/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	25.0% 1/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	26.7% 4/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	13.3% 2/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Infections and infestations Nail infection	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	25.0% 1/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	6.7% 1/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	13.3% 2/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Skin and subcutaneous tissue disorders Nail loss	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	25.0% 1/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	20.0% 3/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	6.7% 1/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Respiratory, thoracic and mediastinal disorders Nasal congestion	66.7% 2/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	25.0% 1/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	20.0% 3/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	20.0% 3/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Gastrointestinal disorders Nausea	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	25.0% 1/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	66.7% 2/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	53.3% 8/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	60.0% 9/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	20.0% 3/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Nervous system disorders Nervous system disorders - Other, specify	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	13.3% 2/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Investigations Neutrophil count decreased	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	100.0% 3/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	50.0% 2/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	86.7% 13/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	46.7% 7/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
General disorders Non-cardiac chest pain	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	25.0% 1/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	6.7% 1/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	6.7% 1/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Gastrointestinal disorders Oral pain	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	6.7% 1/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	6.7% 1/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
General disorders Pain	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	25.0% 1/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	20.0% 3/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Musculoskeletal and connective tissue disorders Pain in extremity	66.7% 2/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	75.0% 3/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	13.3% 2/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	13.3% 2/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Nervous system disorders Paresthesia	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	6.7% 1/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	6.7% 1/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	6.7% 1/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	6.7% 1/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Investigations Platelet count decreased	66.7% 2/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	100.0% 3/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	50.0% 2/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	66.7% 2/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	100.0% 15/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	66.7% 10/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	13.3% 2/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	13.3% 2/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Skin and subcutaneous tissue disorders Rash acneiform	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	6.7% 1/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	13.3% 2/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	40.0% 6/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	20.0% 3/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Reproductive system and breast disorders Reproductive system and breast disorders - Other, specify	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	13.3% 2/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Infections and infestations Sinusitis	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	25.0% 1/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	13.3% 2/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Infections and infestations Skin infection	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	50.0% 2/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	13.3% 2/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	13.3% 2/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Skin and subcutaneous tissue disorders Skin/subcutaneous tissue disorders	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	6.7% 1/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	6.7% 1/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Respiratory, thoracic and mediastinal disorders Sore throat	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	25.0% 1/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	6.7% 1/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	6.7% 1/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Gastrointestinal disorders Stomach pain	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	25.0% 1/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	13.3% 2/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Vascular disorders Thromboembolic event	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	25.0% 1/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	6.7% 1/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Gastrointestinal disorders Toothache	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	25.0% 1/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	6.7% 1/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	6.7% 1/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Nervous system disorders Tremor	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	25.0% 1/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	13.3% 2/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Infections and infestations Upper respiratory infection	100.0% 3/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	40.0% 6/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	6.7% 1/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Renal and urinary disorders Urinary frequency	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	20.0% 3/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	6.7% 1/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Infections and infestations Urinary tract infection	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	13.3% 2/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Gastrointestinal disorders Vomiting	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	25.0% 1/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	13.3% 2/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 5/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Investigations Weight gain	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	26.7% 4/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	13.3% 2/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Investigations Weight loss	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	33.3% 1/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	50.0% 2/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	13.3% 2/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
Investigations White blood cell decreased	66.7% 2/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	66.7% 2/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	50.0% 2/4 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	0.00% 0/3 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	26.7% 4/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.	46.7% 7/15 • Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.

Additional Information

Matthew Davids, MD, MMSc

Dana-Farber Cancer Institute

Phone: 617-632-6331

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place