Trial Outcomes & Findings for SU011248 in Patients With Metastatic Mucosal or Acral/Lentiginous Melanoma (NCT NCT00577382)

Last Updated: 2016-12-08

Results Overview

2-month progression-free survival rate was defined as the proportion of patients absent death or progression based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST) before 2 months. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

52 participants

Primary outcome timeframe

Disease was evaluated radiologically at baseline and every 8 weeks on treatment; Treatment continued for 12 months unless disease progression or unacceptable toxicity. Relevant for this endpoint was disease status at 2 months.

Results posted on

2016-12-08

Participant Flow

The study, conducted at 7 medical centers, was activated on August 8, 2007 and closed on August 1, 2014. Patient enrollment to Cohort A occurred from September 2007 to January 2009 and Cohort B from March 2009 to June 2013.

The trial was amended in 2009 to revise sunitinib dosing due to difficulty with tolerability and evidence of progressive disease following treatment breaks. As such, there are two study cohorts: the first employing intermittent dosing of Sunitinib (Cohort A) and the second with continuous dosing (Cohort B).

Participant milestones

Participant milestones
Measure	Cohort A-Sunitinib Intermittent Dosing Cohort A participants received 50 mg sunitinib orally daily for 4 weeks followed by a two-week break from treatment. These 6-week cycles would be repeated until progression or unacceptable toxicity up to 1 year.	Cohort B-Sunitinib Continuous Dosing Cohort B participants received 37.5 mg sunitinib daily on a continuous basis until progression or unacceptable toxicity up to 1 year.
Overall Study STARTED	21	31
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	21	31

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort A-Sunitinib Intermittent Dosing Cohort A participants received 50 mg sunitinib orally daily for 4 weeks followed by a two-week break from treatment. These 6-week cycles would be repeated until progression or unacceptable toxicity up to 1 year.	Cohort B-Sunitinib Continuous Dosing Cohort B participants received 37.5 mg sunitinib daily on a continuous basis until progression or unacceptable toxicity up to 1 year.
Overall Study Adverse Event	0	6
Overall Study Withdrawal by Subject	0	1
Overall Study Progressive Disease	17	19
Overall Study Intercurrent Illness	1	2
Overall Study Death	1	1
Overall Study Lost to Follow-up	2	2

Baseline Characteristics

SU011248 in Patients With Metastatic Mucosal or Acral/Lentiginous Melanoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort A-Sunitinib Intermittent Dosing n=21 Participants Cohort A participants received 50 mg sunitinib orally daily for 4 weeks followed by a two-week break from treatment. These 6-week cycles would be repeated until progression or unacceptable toxicity up to 1 year.	Cohort B-Sunitinib Continuous Dosing n=31 Participants Cohort B participants received 37.5 mg sunitinib daily on a continuous basis until progression or unacceptable toxicity up to 1 year.	Total n=52 Participants Total of all reporting groups
Age, Continuous	63 years n=5 Participants	63 years n=7 Participants	63 years n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	20 Participants n=7 Participants	30 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants	28 Participants n=7 Participants	49 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants	31 participants n=7 Participants	52 participants n=5 Participants

PRIMARY outcome

Timeframe: Disease was evaluated radiologically at baseline and every 8 weeks on treatment; Treatment continued for 12 months unless disease progression or unacceptable toxicity. Relevant for this endpoint was disease status at 2 months.

Population: The analysis dataset is comprised of treated patients.

Outcome measures

Outcome measures
Measure	Cohort A-Sunitinib Intermittent Dosing n=21 Participants Cohort A participants received 50 mg sunitinib orally daily for 4 weeks followed by a two-week break from treatment. These 6-week cycles would be repeated until progression or unacceptable toxicity up to 1 year.	Cohort B-Sunitinib Continuous Dosing n=31 Participants Cohort B participants received 37.5 mg sunitinib daily on a continuous basis until progression or unacceptable toxicity up to 1 year.
2-month Progression-free Survival Rate	.52 proportion of patients Interval 0.3 to 0.74	.52 proportion of patients Interval 0.33 to 0.7

SECONDARY outcome

Timeframe: Disease was evaluated radiologically at baseline and every 8 weeks on treatment. Mean treatment duration was 3 cycles (Cohort A/B mean 2/3 cycles). The range of treatment duration overall was 1-11 cycles.

Population: The analysis dataset is comprised of treated patients.

The best overall response rate was defined as achieving partial response (PR) or complete response (CR) on treatment based on RECIST 1.0 criteria. Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.

Outcome measures

Outcome measures
Measure	Cohort A-Sunitinib Intermittent Dosing n=21 Participants Cohort A participants received 50 mg sunitinib orally daily for 4 weeks followed by a two-week break from treatment. These 6-week cycles would be repeated until progression or unacceptable toxicity up to 1 year.	Cohort B-Sunitinib Continuous Dosing n=31 Participants Cohort B participants received 37.5 mg sunitinib daily on a continuous basis until progression or unacceptable toxicity up to 1 year.
Best Overall Response Rate	0.095 proportion of participants Interval 0.012 to 0.304	0.065 proportion of participants Interval 0.0078 to 0.214

SECONDARY outcome

Timeframe: Patients were followed long-term every 3 months until first progression, death or lost to follow-up. Median survival follow-up was 6.7 months (range 0.8-47.3 months; Cohort A/B median 7.7 m/ 6.2 m).

Population: The analysis dataset is comprised of treated patients.

Overall survival (OS) is defined as the time from study entry to death or date last known alive.

Outcome measures

Outcome measures
Measure	Cohort A-Sunitinib Intermittent Dosing n=21 Participants Cohort A participants received 50 mg sunitinib orally daily for 4 weeks followed by a two-week break from treatment. These 6-week cycles would be repeated until progression or unacceptable toxicity up to 1 year.	Cohort B-Sunitinib Continuous Dosing n=31 Participants Cohort B participants received 37.5 mg sunitinib daily on a continuous basis until progression or unacceptable toxicity up to 1 year.
Overall Survival	7.7 months Interval 6.9 to 14.9	6.8 months Interval 5.2 to 9.6

SECONDARY outcome

Timeframe: Disease was evaluated radiologically at baseline and every 8 weeks on treatment and long-term every 3 months until first progression, death or lost to follow-up. Mean treatment duration was 3 cycles (range 1-11; Cohort A/B mean 2/3 cycles).

Population: The analysis dataset is comprised of treated patients. The majority of patients were off-treatment due to disease progression and thus the relevant observation time frame for this outcome is time on treatment.

Time to progression based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.

Outcome measures

Outcome measures
Measure	Cohort A-Sunitinib Intermittent Dosing n=21 Participants Cohort A participants received 50 mg sunitinib orally daily for 4 weeks followed by a two-week break from treatment. These 6-week cycles would be repeated until progression or unacceptable toxicity up to 1 year.	Cohort B-Sunitinib Continuous Dosing n=31 Participants Cohort B participants received 37.5 mg sunitinib daily on a continuous basis until progression or unacceptable toxicity up to 1 year.
Time to Progression	2.7 months Interval 1.7 to 4.1	3.6 months Interval 1.7 to 3.9

Adverse Events

Cohort A-Sunitinib Intermittent Dosing

Serious events: 10 serious events

Other events: 19 other events

Deaths: 0 deaths

Cohort B-Sunitinib Continuous Dosing

Serious events: 13 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

F. Stephen Hodi, MD

Dana-Farber Cancer Institute

Phone: 617.632.5053

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Cohort A-Sunitinib Intermittent Dosing n=21 participants at risk Cohort A participants received 50 mg sunitinib orally daily for 4 weeks followed by a two-week break from treatment. These 6-week cycles would be repeated until progression or unacceptable toxicity up to 1 year.	Cohort B-Sunitinib Continuous Dosing n=31 participants at risk Cohort B participants received 37.5 mg sunitinib daily on a continuous basis until progression or unacceptable toxicity up to 1 year.
Investigations ALT, SGPT	4.8% 1/21 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.	0.00% 0/31 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Investigations Amylase	9.5% 2/21 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.	6.5% 2/31 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Investigations AST, SGOT	4.8% 1/21 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.	0.00% 0/31 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
General disorders Death - sudden death	4.8% 1/21 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.	0.00% 0/31 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Metabolism and nutrition disorders Dehydration	0.00% 0/21 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.	3.2% 1/31 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Gastrointestinal disorders Diarrhea w/o prior colostomy	0.00% 0/21 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.	3.2% 1/31 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
General disorders Fatigue	4.8% 1/21 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.	3.2% 1/31 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Skin and subcutaneous tissue disorders Hand-foot reaction	0.00% 0/21 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.	6.5% 2/31 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Blood and lymphatic system disorders Hemoglobin	4.8% 1/21 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.	3.2% 1/31 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Vascular disorders Hypertension	4.8% 1/21 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.	3.2% 1/31 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Infections and infestations Infection w/ gr3-4 neut, nose	0.00% 0/21 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.	3.2% 1/31 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Investigations Leukocytes	4.8% 1/21 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.	9.7% 3/31 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Investigations Lipase	9.5% 2/21 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.	9.7% 3/31 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Investigations Lymphopenia	4.8% 1/21 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.	9.7% 3/31 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Investigations Neutrophils	0.00% 0/21 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.	9.7% 3/31 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Gastrointestinal disorders Pancreatitis	0.00% 0/21 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.	3.2% 1/31 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Investigations Platelets	0.00% 0/21 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.	9.7% 3/31 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Gastrointestinal disorders Stomach, hemorrhage	4.8% 1/21 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.	0.00% 0/31 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Nervous system disorders Syncope	4.8% 1/21 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.	0.00% 0/31 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Gastrointestinal disorders Vomiting	9.5% 2/21 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.	0.00% 0/31 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.