Trial Outcomes & Findings for A Phase 1b/2 Study of IPI-145 Plus FCR in Previously Untreated, Younger Patients With CLL (NCT NCT02158091)
NCT ID: NCT02158091
Last Updated: 2025-08-27
Results Overview
To assess the safety of IPI145 in combination with FCR in previously untreated younger patients with CLL. 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 3 or greater hematologic toxicity (except Grade 3 or Grade 4 neutropenia or thrombocytopenia that lasts less than or equal to 10 days off treatment), any Grade 3 or greater non-hematologic toxicity (except Grade 3 or greater nausea, vomiting, diarrhea, Grade 3 infusion reactions), Grade 3 asymptomatic laboratory abnormalities that improve to grade 2 or less within 3 days, Inability to receive day 1 therapy of Cycle 2 even after a three week treatment delay due to drug related toxicity from prior cycle, and any Grade 4 or greater elevation in AST ALT values
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1/PHASE2
Target enrollment
32 participants
Primary outcome timeframe
. Participants were assessed every week or more often as needed during Cycle 1, and every Day 1 Cycles 2 and onward-Dose-limiting toxicities (DLTs) occurring during the first cycle of treatment will be used in determining the Phase II MTD/RP2D
Results posted on
2025-08-27
Participant Flow
Participants in the Phase I portion of the study enrolled in outpatient clinic setting from 6/27/2014 to 1/13/2015 and to the Phase II study from 4/14/2015 to 8/15/2016
Participant milestones
| Measure |
Phase I Cohort 1: IPI-145 25mg Once Daily + FCR
Phase I Cohort 1 patients received oral agent IPI-145 25mg daily on days 1-28 of a 28 day cycle, except for Cycle 1, which lasts 35 with a 7 day IPI-145 run in, then will continue daily dosing for 6 cycles and up to 2 years of maintenance. Fludarabine, cyclophosphamide, rituximab (FCR) swill be given standard dosing intravenously (IV) Days 1-3 during week 1 of a cycle for up to 6 cycles, with dose reductions permitted. 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.
|
Phase I Cohort 2 (MTD): IPI-145 25mg Twice Daily + FCR
Phase I Cohort 2 patients received oral agent IPI-145 25mg twice daily ( BID)on days 1-28 of a 28 day cycle, except for Cycle 1, which lasts 35 with a 7 day IPI-145 run in, then will continue daily dosing for 6 cycles and up to 2 years of maintenance. Fludarabine, cyclophosphamide, rituximab (FCR) swill be given standard dosing intravenously (IV) Days 1-3 during week 1 of a cycle for up to 6 cycles, with dose reductions permitted. 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.
|
Phase II Dose Expansion(RP2D)-IPI-145 25mg Twice Daily + FCR
Phase II (MTD)CLL participants received the regimen established in the Phase I study ( January 2015). Phase II Participants received oral IPI-145 25mg twice daily (BID) for up to 6 cycles of combination therapy and 2 years of maintenance ( monotherapy) and received standard dosing if Fludarabine, Cyclophosphamide, and Rituxan (FCR) on days 1-3 of each cycle for up to 6 cycles. 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
|
6
|
6
|
20
|
|
Overall Study
COMPLETED
|
4
|
5
|
20
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
0
|
Reasons for withdrawal
| Measure |
Phase I Cohort 1: IPI-145 25mg Once Daily + FCR
Phase I Cohort 1 patients received oral agent IPI-145 25mg daily on days 1-28 of a 28 day cycle, except for Cycle 1, which lasts 35 with a 7 day IPI-145 run in, then will continue daily dosing for 6 cycles and up to 2 years of maintenance. Fludarabine, cyclophosphamide, rituximab (FCR) swill be given standard dosing intravenously (IV) Days 1-3 during week 1 of a cycle for up to 6 cycles, with dose reductions permitted. 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.
|
Phase I Cohort 2 (MTD): IPI-145 25mg Twice Daily + FCR
Phase I Cohort 2 patients received oral agent IPI-145 25mg twice daily ( BID)on days 1-28 of a 28 day cycle, except for Cycle 1, which lasts 35 with a 7 day IPI-145 run in, then will continue daily dosing for 6 cycles and up to 2 years of maintenance. Fludarabine, cyclophosphamide, rituximab (FCR) swill be given standard dosing intravenously (IV) Days 1-3 during week 1 of a cycle for up to 6 cycles, with dose reductions permitted. 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.
|
Phase II Dose Expansion(RP2D)-IPI-145 25mg Twice Daily + FCR
Phase II (MTD)CLL participants received the regimen established in the Phase I study ( January 2015). Phase II Participants received oral IPI-145 25mg twice daily (BID) for up to 6 cycles of combination therapy and 2 years of maintenance ( monotherapy) and received standard dosing if Fludarabine, Cyclophosphamide, and Rituxan (FCR) on days 1-3 of each cycle for up to 6 cycles. 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
DLT
|
2
|
1
|
0
|
Baseline Characteristics
A Phase 1b/2 Study of IPI-145 Plus FCR in Previously Untreated, Younger Patients With CLL
Baseline characteristics by cohort
| Measure |
Phase I Cohort 1: IPI-145 25mg Once Daily + FCR
n=6 Participants
Phase I Cohort 1 patients received oral agent IPI-145 25mg daily on days 1-28 of a 28 day cycle, except for Cycle 1, which lasts 35 with a 7 day IPI-145 run in, then will continue daily dosing for 6 cycles and up to 2 years of maintenance. Fludarabine, cyclophosphamide, rituximab (FCR) swill be given standard dosing intravenously (IV) Days 1-3 during week 1 of a cycle for up to 6 cycles, with dose reductions permitted. 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.
|
Phase I Cohort 2: IPI-145 25mg Once Daily
n=6 Participants
Phase I Cohort 2 patients received oral agent IPI-145 25mg twice BID) daily on days 1-28 of a 28 day cycle, except for Cycle 1, which lasts 35 with a 7 day IPI-145 run in, then will continue daily dosing for 6 cycles and up to 2 years of maintenance. Fludarabine, cyclophosphamide, rituximab (FCR) swill be given standard dosing intravenously (IV) Days 1-3 during week 1 of a cycle for up to 6 cycles, with dose reductions permitted. 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.
|
Phase II Dose Expansion ( MTD): IPI 145 25mg BID
n=20 Participants
Phase II (MTD) CLL participants received the regimen established in the Phase I study ( January 2015). Phase II Participants received oral IPI-145 25mg twice daily (BID) for up to 6 cycles of combination therapy and 2 years of maintenance ( monotherapy) and received standard dosing if Fludarabine, Cyclophosphamide, and Rituxan (FCR) on days 1-3 of each cycle for up to 6 cycles. 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=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
31 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
22 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
28 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
30 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=93 Participants
|
6 participants
n=4 Participants
|
20 participants
n=27 Participants
|
32 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: . Participants were assessed every week or more often as needed during Cycle 1, and every Day 1 Cycles 2 and onward-Dose-limiting toxicities (DLTs) occurring during the first cycle of treatment will be used in determining the Phase II MTD/RP2DPopulation: Patients who have received no prior therapy for CLL but who meet IW-CLL 2008 Criteria for requiring treatment
To assess the safety of IPI145 in combination with FCR in previously untreated younger patients with CLL. 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 3 or greater hematologic toxicity (except Grade 3 or Grade 4 neutropenia or thrombocytopenia that lasts less than or equal to 10 days off treatment), any Grade 3 or greater non-hematologic toxicity (except Grade 3 or greater nausea, vomiting, diarrhea, Grade 3 infusion reactions), Grade 3 asymptomatic laboratory abnormalities that improve to grade 2 or less within 3 days, Inability to receive day 1 therapy of Cycle 2 even after a three week treatment delay due to drug related toxicity from prior cycle, and any Grade 4 or greater elevation in AST ALT values
Outcome measures
| Measure |
Phase I Cohort 1: IPI-145 25mg Once Daily + FCR
n=6 Participants
Phase I Cohort 1 patients received oral agent IPI-145 25mg daily on days 1-28 of a 28 day cycle, except for Cycle 1, which lasts 35 with a 7 day IPI-145 run in, then will continue daily dosing for 6 cycles and up to 2 years of maintenance. Fludarabine, cyclophosphamide, rituximab (FCR) swill be given standard dosing intravenously (IV) Days 1-3 during week 1 of a cycle for up to 6 cycles, with dose reductions permitted. 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.
|
Phase I Cohort 2 (MTD): IPI-145 25mg Twice Daily + FCR
n=6 Participants
Phase I Cohort 2 patients received oral agent IPI-145 25mg twice daily ( BID)on days 1-28 of a 28 day cycle, except for Cycle 1, which lasts 35 with a 7 day IPI-145 run in, then will continue daily dosing for 6 cycles and up to 2 years of maintenance. Fludarabine, cyclophosphamide, rituximab (FCR) swill be given standard dosing intravenously (IV) Days 1-3 during week 1 of a cycle for up to 6 cycles, with dose reductions permitted. 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
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 2 months after completion of combination therapy of IPI-145 and FCRTo determine the rate of minimal residual disease negative complete response (MRD negative CR) in the bone marrow at 2 months post last cycle of FCR, participants will have a bone marrow biopsy procedure 2 months after completing combination therapy (IPI-145+ FCR) in tandem with a chest,neck, abdomen and pelvic PET CT scan. A central read of the PET CT scan will confirm a radiographic complete response, and the bone marrow pathology and morphology assessments will confirm morphological CR in the bone marrow, while MRD testing will be done by four-color flow cytometry on the bone marrow aspirate with a detection level of 10-4. This will include all patients treated and evaluable at maximum tolerated dose, and at the recommended phase II dose ( RP2D)
Outcome measures
| Measure |
Phase I Cohort 1: IPI-145 25mg Once Daily + FCR
n=26 Participants
Phase I Cohort 1 patients received oral agent IPI-145 25mg daily on days 1-28 of a 28 day cycle, except for Cycle 1, which lasts 35 with a 7 day IPI-145 run in, then will continue daily dosing for 6 cycles and up to 2 years of maintenance. Fludarabine, cyclophosphamide, rituximab (FCR) swill be given standard dosing intravenously (IV) Days 1-3 during week 1 of a cycle for up to 6 cycles, with dose reductions permitted. 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.
|
Phase I Cohort 2 (MTD): IPI-145 25mg Twice Daily + FCR
Phase I Cohort 2 patients received oral agent IPI-145 25mg twice daily ( BID)on days 1-28 of a 28 day cycle, except for Cycle 1, which lasts 35 with a 7 day IPI-145 run in, then will continue daily dosing for 6 cycles and up to 2 years of maintenance. Fludarabine, cyclophosphamide, rituximab (FCR) swill be given standard dosing intravenously (IV) Days 1-3 during week 1 of a cycle for up to 6 cycles, with dose reductions permitted. 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 Had a Minimal Residual Disease (MRD) Negative Complete Response (CR) 2 Months After Chemotherapy
|
23 Percentage of participants
Interval 9.0 to 44.0
|
—
|
SECONDARY outcome
Timeframe: At baseline, End of Cycle 3, and 2 months post FCRResponse and progression will be evaluated in this study using the 2008 IW-CLL criteria for CLL (Hallek et al., 2008)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 210 daysToxicity assessments will be done using the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) and will include all participants who have received at least 1 dose of IPI-145. Toxicities will be assessed at minimum every week during cycle 1, on Day 1 of every cycle during Cycle 2 onward, and every other cycle Day 1 during maintenance.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 YearsParticipants will have MRD testing in the peripheral blood by four-color flow cytometry at the end of cycle 3, 2 months post combination therapy, and every 6 months thereafter for the duration of treatment and subsequent follow up
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 210 daysParticipants will be evaluable for this endpoint if they have had at least 1 dose of study treatment. Toxicities will be assessed at minimum each week during cycle 1, and each day 1 during combination therapy, and then every two months thereafter. CTCAE version 4.0 will be used to assess toxicity term and grading.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 YearsFisher's exact test for categorical variables and Wilcoxon's rank sum test will be used-
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline, End of Cycle 3, and 2 months post FCR and then per investigator discretion thereafterResponse and progression will be evaluated in this study using the 2008 IW-CLL criteria for CLL (Hallek et al., 2008)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline, End of Cycle 3, and 2 months post FCR and then per investigator discretion thereafter2008 IW-CLL criteria
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline, End of Cycle 3, and 2 months post FCR and then per investigator discretion thereafterResponse and progression will be evaluated in this study using the 2008 IW-CLL criteria for CLL (Hallek et al., 2008)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline, End of Cycle 3, and 2 months post FCR and then per investigator discretion thereafterResponse and progression will be evaluated in this study using the 2008 IW-CLL criteria for CLL (Hallek et al., 2008)Frequency of follow up visits and scans are per MD discretion. Recommended follow up visits for a minimum of one year
Outcome measures
Outcome data not reported
Adverse Events
Phase 1 Cohort 1: IPI-145 25mg Once Daily + FCR
Serious events: 6 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase 1 Cohort 2: IPI-145 25mg Twice Daily + FCR
Serious events: 6 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase II Dose Expansion(MTD)-IPI-145 25mg Twice Daily + FCR
Serious events: 20 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 1 Cohort 1: IPI-145 25mg Once Daily + FCR
n=6 participants at risk
Phase I Cohort 1 patients received oral agent IPI-145 25mg daily on days 1-28 of a 28 day cycle, except for Cycle 1, which lasts 35 with a 7 day IPI-145 run in, then will continue daily dosing for 6 cycles and up to 2 years of maintenance. Fludarabine, cyclophosphamide, rituximab (FCR) swill be given standard dosing intravenously (IV) Days 1-3 during week 1 of a cycle for up to 6 cycles, with dose reductions permitted. 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.
|
Phase 1 Cohort 2: IPI-145 25mg Twice Daily + FCR
n=6 participants at risk
Phase I Cohort 2 patients received oral agent IPI-145 25mg twice daily ( BID)on days 1-28 of a 28 day cycle, except for Cycle 1, which lasts 35 with a 7 day IPI-145 run in, then will continue daily dosing for 6 cycles and up to 2 years of maintenance. Fludarabine, cyclophosphamide, rituximab (FCR) swill be given standard dosing intravenously (IV) Days 1-3 during week 1 of a cycle for up to 6 cycles, with dose reductions permitted. 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.
|
Phase II Dose Expansion(MTD)-IPI-145 25mg Twice Daily + FCR
n=20 participants at risk
Phase II (MTD)CLL participants received the regimen established in the Phase I study ( January 2015). Phase II Participants received oral IPI-145 25mg twice daily (BID) for up to 6 cycles of combination therapy and 2 years of maintenance ( monotherapy) and received standard dosing if Fludarabine, Cyclophosphamide, and Rituxan (FCR) on days 1-3 of each cycle for up to 6 cycles. 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.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
33.3%
2/6 • Number of events 2 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
16.7%
1/6 • Number of events 1 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
10.0%
2/20 • Number of events 2 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
Lung Infection
|
33.3%
2/6 • Number of events 2 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
2/6 • Number of events 2 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
5.0%
1/20 • Number of events 1 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
|
0.00%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
4/20 • Number of events 4 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
Pericarditis
|
0.00%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
5.0%
1/20 • Number of events 1 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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)
Myelodysplastic Syndrome
|
16.7%
1/6 • Number of events 1 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
|
16.7%
1/6 • Number of events 1 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
Thrombocytopenia
|
16.7%
1/6 • Number of events 1 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
3/6 • Number of events 3 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
5/20 • Number of events 5 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
Leukopenia
|
50.0%
3/6 • Number of events 3 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
3/6 • Number of events 3 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
4/20 • Number of events 4 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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 Decrease
|
83.3%
5/6 • Number of events 5 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
4/6 • Number of events 4 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
10/20 • Number of events 10 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
Lymphopenia
|
83.3%
5/6 • Number of events 5 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
4/6 • Number of events 4 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
5/20 • Number of events 5 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
16.7%
1/6 • Number of events 1 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
5.0%
1/20 • Number of events 1 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
|
0.00%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
16.7%
1/6 • Number of events 1 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
15.0%
3/20 • Number of events 3 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
|
0.00%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
16.7%
1/6 • Number of events 1 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
15.0%
3/20 • Number of events 3 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
|
16.7%
1/6 • Number of events 1 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
|
Hepatobiliary disorders
Drug Induced Liver Injury
|
0.00%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
5.0%
1/20 • Number of events 1 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
|
Hepatobiliary disorders
Pancreatitis
|
0.00%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
5.0%
1/20 • Number of events 1 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
|
Immune system disorders
Inflammatory Bursitis
|
0.00%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
5.0%
1/20 • Number of events 1 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
|
0.00%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
5.0%
1/20 • Number of events 1 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
Neck Stiffness
|
0.00%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
5.0%
1/20 • Number of events 1 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
Amylase Increased
|
0.00%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
5.0%
1/20 • Number of events 1 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
|
Immune system disorders
Pityriasis Rubra Pilaris Reaction
|
0.00%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
5.0%
1/20 • Number of events 1 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
|
Hepatobiliary disorders
Blood Bilirubin Increased
|
0.00%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
5.0%
1/20 • Number of events 1 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
| Measure |
Phase 1 Cohort 1: IPI-145 25mg Once Daily + FCR
n=6 participants at risk
Phase I Cohort 1 patients received oral agent IPI-145 25mg daily on days 1-28 of a 28 day cycle, except for Cycle 1, which lasts 35 with a 7 day IPI-145 run in, then will continue daily dosing for 6 cycles and up to 2 years of maintenance. Fludarabine, cyclophosphamide, rituximab (FCR) swill be given standard dosing intravenously (IV) Days 1-3 during week 1 of a cycle for up to 6 cycles, with dose reductions permitted. 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.
|
Phase 1 Cohort 2: IPI-145 25mg Twice Daily + FCR
n=6 participants at risk
Phase I Cohort 2 patients received oral agent IPI-145 25mg twice daily ( BID)on days 1-28 of a 28 day cycle, except for Cycle 1, which lasts 35 with a 7 day IPI-145 run in, then will continue daily dosing for 6 cycles and up to 2 years of maintenance. Fludarabine, cyclophosphamide, rituximab (FCR) swill be given standard dosing intravenously (IV) Days 1-3 during week 1 of a cycle for up to 6 cycles, with dose reductions permitted. 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.
|
Phase II Dose Expansion(MTD)-IPI-145 25mg Twice Daily + FCR
n=20 participants at risk
Phase II (MTD)CLL participants received the regimen established in the Phase I study ( January 2015). Phase II Participants received oral IPI-145 25mg twice daily (BID) for up to 6 cycles of combination therapy and 2 years of maintenance ( monotherapy) and received standard dosing if Fludarabine, Cyclophosphamide, and Rituxan (FCR) on days 1-3 of each cycle for up to 6 cycles. 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
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
15.0%
3/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
2/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
8/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
|
0.00%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
15.0%
3/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
Allergic rhinitis
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
2/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
|
50.0%
3/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
2/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
35.0%
7/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
|
83.3%
5/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
3/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
15.0%
3/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
2/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
|
0.00%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
10.0%
2/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
|
33.3%
2/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
35.0%
7/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
|
33.3%
2/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
5.0%
1/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
5.0%
1/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
|
0.00%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
10.0%
2/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
|
0.00%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
5.0%
1/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
Bone pain
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
|
0.00%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
5.0%
1/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
Cardiac disorders - Other, specify
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
Chills
|
66.7%
4/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
10.0%
2/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
|
0.00%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
10.0%
2/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
|
83.3%
5/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
2/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
10.0%
2/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
|
66.7%
4/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
4/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
4/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
|
33.3%
2/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
Depression
|
0.00%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
4/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
2/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
45.0%
9/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
Dry mouth
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
15.0%
3/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
|
0.00%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
10.0%
2/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
|
66.7%
4/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
30.0%
6/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
Edema limbs
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
10.0%
2/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
Esophageal pain
|
0.00%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
5.0%
1/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
Eye disorders - Other, specify
|
0.00%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
2/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
5.0%
1/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
Eye pain
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
6/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
6/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
10/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
Febrile neutropenia
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
10.0%
2/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
|
Immune system disorders
Fever
|
66.7%
4/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
4/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
45.0%
9/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
Flank pain
|
0.00%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
5.0%
1/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
|
Immune system disorders
Flu like symptoms
|
0.00%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
Flushing
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
10.0%
2/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
|
66.7%
4/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
2/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
4/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
General disorders and administration site conditions - Other, specify
|
50.0%
3/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
15.0%
3/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
|
33.3%
2/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
|
50.0%
3/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
10.0%
2/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
Hiccups
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
10.0%
2/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
|
33.3%
2/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
|
33.3%
2/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
5.0%
1/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
5.0%
1/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
|
0.00%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
5.0%
1/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
5.0%
1/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
|
33.3%
2/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
5.0%
1/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
Injury, poisoning and procedural complications - Other, specify
|
0.00%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
5.0%
1/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
|
50.0%
3/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
5.0%
1/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
Investigations - Other, specify
|
0.00%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
5.0%
1/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
Laryngeal inflammation
|
0.00%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
|
0.00%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
10.0%
2/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
5.0%
1/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
5.0%
1/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
|
50.0%
3/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
2/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
4/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
|
0.00%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
5.0%
1/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
10.0%
2/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
5.0%
1/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
Muscle weakness lower limb
|
0.00%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
5.0%
1/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
|
33.3%
2/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
4/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
10.0%
2/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
|
0.00%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
|
33.3%
2/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
|
100.0%
6/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
83.3%
5/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
12/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
|
0.00%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
5.0%
1/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
|
83.3%
5/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
3/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
45.0%
9/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
Non-cardiac chest pain
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
15.0%
3/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
5.0%
1/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
10.0%
2/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
2/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
5.0%
1/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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 motor neuropathy
|
0.00%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
5.0%
1/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
15.0%
3/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
Pharyngeal necrosis
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
|
100.0%
6/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
2/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
10/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
Postnasal drip
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
10.0%
2/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
Productive cough
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
|
66.7%
4/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
5.0%
1/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
5.0%
1/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
4/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
Renal and urinary disorders - Other, specify
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
Respiratory, thoracic and mediastinal disorders
|
0.00%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
5.0%
1/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
Respiratory, thoracic and mediastinal disorders - Other, specify
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
Restlessness
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
Serum amylase increased
|
0.00%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
5.0%
1/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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 and subcutaneous tissue disorders - Other, specify
|
66.7%
4/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
2/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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; Other, specify
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
4/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
15.0%
3/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
5.0%
1/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
Syncope
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
Tinnitus
|
0.00%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
5.0%
1/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
Tooth discoloration
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
|
50.0%
3/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
2/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
10.0%
2/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
|
0.00%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
5.0%
1/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
Vaginal infection
|
0.00%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
Vascular disorders - Other, specify
|
0.00%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
|
66.7%
4/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
4/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
|
33.3%
2/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
Wheezing
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
|
100.0%
6/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
4/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
4/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
Wound infection
|
0.00%
0/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review.
|
16.7%
1/6 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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%
0/20 • Adverse events are assessed at minimum every week during cycle 1, and day 1 of every cycle thereafter during combination, and every two cycles thereafter while in maintenance. Treatment duration in cycles was a a median of 6 cycles in Phase I Cohort 1, 4.5 cycles in Phase I Cohort 2 and 5.5 cycles in the Phase II MTD
Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, and all grade 4 and 5 events regardless of attribution to study treatment, and includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place