Trial Outcomes & Findings for Study of Hsp90 Inhibitor, STA-9090 for Relapsed or Refractory Small Cell Lung Cancer (NCT NCT01173523)

NCT ID: NCT01173523

Last Updated: 2019-04-16

Results Overview

The 8-week progression free rate is defined as the percentage of participants achieving complete response (CR), partial response (PR) or stable disease (SD) based on RECIST 1.1 criteria by the time of the first disease assessment (8 weeks). Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions; PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD; and SD is neither sufficient decrease to qualify as PR nor sufficient increase to qualify as progressive disease (PD). PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. Response needed confirmation within 4 weeks. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions or not evaluated.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 25 participants
• Primary outcome timeframe: Disease was evaluated radiographically at baseline and every 8 weeks on treatment; Treatment continued until disease progression or unacceptable toxicity. Relevant for this endpoint was the first 8 week disease re-assessment.
• Results posted on: 2019-04-16

Participant Flow

Patients enrolled from July 2010 through March 2013.

Participant milestones

Measure	Cohort A: STA-9090 Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort A participants had relapsed \> 60 days following initial chemotherapy completion.	Cohort B: STA-9090 Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort B participants had not responded or had relapsed \</= 60 days from the completion of initial chemotherapy.
Overall Study STARTED	13	12
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	13	12

Reasons for withdrawal

Measure	Cohort A: STA-9090 Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort A participants had relapsed \> 60 days following initial chemotherapy completion.	Cohort B: STA-9090 Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort B participants had not responded or had relapsed \</= 60 days from the completion of initial chemotherapy.
Overall Study Clinical Progression	1	1
Overall Study Progressive Disease	10	8
Overall Study Other	2	3

Baseline Characteristics

Study of Hsp90 Inhibitor, STA-9090 for Relapsed or Refractory Small Cell Lung Cancer

Baseline characteristics by cohort

Measure	Cohort A: STA-9090 n=13 Participants Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort A participants had relapsed \> 60 days following initial chemotherapy completion.	Cohort B: STA-9090 n=12 Participants Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort B participants had not responded or had relapsed \</= 60 days from the completion of initial chemotherapy.	Total n=25 Participants Total of all reporting groups
Age, Continuous	62 years n=5 Participants	59.5 years n=7 Participants	61 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants	12 participants n=7 Participants	25 participants n=5 Participants

PRIMARY outcome

Timeframe: Disease was evaluated radiographically at baseline and every 8 weeks on treatment; Treatment continued until disease progression or unacceptable toxicity. Relevant for this endpoint was the first 8 week disease re-assessment.

Population: The analysis dataset is comprised of all treated patients.

The 8-week progression free rate is defined as the percentage of participants achieving complete response (CR), partial response (PR) or stable disease (SD) based on RECIST 1.1 criteria by the time of the first disease assessment (8 weeks). Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions; PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD; and SD is neither sufficient decrease to qualify as PR nor sufficient increase to qualify as progressive disease (PD). PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. Response needed confirmation within 4 weeks. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions or not evaluated.

Outcome measures

Measure	Cohort A: STA-9090 n=13 Participants Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort A participants had relapsed \> 60 days following initial chemotherapy completion.	Cohort B: STA-9090 n=12 Participants Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort B participants had not responded or had relapsed \</= 60 days from the completion of initial chemotherapy.
8-Week Progression-Free Rate	0.0 percentage of participants Interval 0.0 to 24.7	8.3 percentage of participants Interval 0.2 to 38.5

SECONDARY outcome

Timeframe: Disease was evaluated radiographically at baseline and every 8 weeks on treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles in this study cohort.

Population: The analysis dataset is comprised of all treated patients.

The objective response rate (ORR) was defined as the percentage of participants achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 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. 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

Measure	Cohort A: STA-9090 n=13 Participants Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort A participants had relapsed \> 60 days following initial chemotherapy completion.	Cohort B: STA-9090 n=12 Participants Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort B participants had not responded or had relapsed \</= 60 days from the completion of initial chemotherapy.
Overall Response Rate	0.0 percentage of participants Interval 0.0 to 24.7	0.0 percentage of participants Interval 0.0 to 26.5

SECONDARY outcome

Timeframe: Disease was evaluated radiographically at baseline and every 8 weeks on treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles in this study cohort.

Population: The analysis dataset is comprised of all treated patients.

Progression-free survival (PFS) based on the Kaplan-Meier method is defined as the time from study entry to the earliest documentation of disease progression (PD) based on RECIST 1.1 criteria or death. Participants alive without evidence of PD were censored at the date of last adequate disease assessment. Per RECIST 1.1 for target lesions PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. For non-target lesions, progression is appearance of one or more new lesions and/or unequivocal progression on existing non-target lesions.

Outcome measures

Measure	Cohort A: STA-9090 n=13 Participants Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort A participants had relapsed \> 60 days following initial chemotherapy completion.	Cohort B: STA-9090 n=12 Participants Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort B participants had not responded or had relapsed \</= 60 days from the completion of initial chemotherapy.
Progression-Free Survival	1.61 months Interval 1.61 to Follow-up is not long enough/Data is not mature to provide upper bound 95% CI.	1.81 months Interval 1.15 to Follow-up is not long enough/Data is not mature to provide upper bound 95% CI.

SECONDARY outcome

Timeframe: Long-term follow-up for survival occurred every 4 weeks. As of this analysis, follow-up among survivors was a median (range) of 11.5 months (0.9-47.9).

Population: The analysis dataset is comprised of treated patients.

Overall survival estimated using Kaplan-Meier (KM) methods is defined as the time from study entry to death due to any cause or date last known alive.

Outcome measures

Measure	Cohort A: STA-9090 n=13 Participants Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort A participants had relapsed \> 60 days following initial chemotherapy completion.	Cohort B: STA-9090 n=12 Participants Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort B participants had not responded or had relapsed \</= 60 days from the completion of initial chemotherapy.
Overall Survival	4.96 months Interval 3.45 to Follow-up is not long enough/Data is not mature to provide upper bound 95% CI.	6.70 months Interval 2.27 to Follow-up is not long enough/Data is not mature to provide upper bound 95% CI.

Adverse Events

Cohort A: STA-9090

Serious events: 4 serious events

Other events: 7 other events

Deaths: 0 deaths

Cohort B: STA-9090

Serious events: 3 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cohort A: STA-9090 n=13 participants at risk Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort A participants had relapsed \> 60 days following initial chemotherapy completion.	Cohort B: STA-9090 n=12 participants at risk Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort B participants had not responded or had relapsed \</= 60 days from the completion of initial chemotherapy.
Gastrointestinal disorders Abdominal distension	0.00% 0/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	8.3% 1/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Gastrointestinal disorders Abdominal pain	0.00% 0/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	8.3% 1/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Investigations Alanine aminotransferase increased	0.00% 0/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	8.3% 1/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Investigations Alkaline phosphatase increased	7.7% 1/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	8.3% 1/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Immune system disorders Allergic reaction	0.00% 0/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	8.3% 1/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Blood and lymphatic system disorders Anemia	7.7% 1/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	8.3% 1/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Metabolism and nutrition disorders Anorexia	0.00% 0/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	8.3% 1/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Investigations Aspartate aminotransferase increased	0.00% 0/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	8.3% 1/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
General disorders Chills	0.00% 0/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	8.3% 1/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Gastrointestinal disorders Constipation	0.00% 0/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	8.3% 1/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	8.3% 1/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Metabolism and nutrition disorders Dehydration	0.00% 0/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	8.3% 1/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Gastrointestinal disorders Diarrhea	7.7% 1/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	8.3% 1/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Gastrointestinal disorders Dry mouth	0.00% 0/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	8.3% 1/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Nervous system disorders Dysgeusia	0.00% 0/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	8.3% 1/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Gastrointestinal disorders Dyspepsia	0.00% 0/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	8.3% 1/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	8.3% 1/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Eye disorders Eye disorders - Other	0.00% 0/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	8.3% 1/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
General disorders Fatigue	7.7% 1/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	8.3% 1/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Vascular disorders Flushing	0.00% 0/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	8.3% 1/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	8.3% 1/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	8.3% 1/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Metabolism and nutrition disorders Hypomagnesemia	0.00% 0/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	8.3% 1/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Metabolism and nutrition disorders Hyponatremia	7.7% 1/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	25.0% 3/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Metabolism and nutrition disorders Hypophosphatemia	7.7% 1/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	8.3% 1/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Infections and infestations Infections and infestations - Other	0.00% 0/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	8.3% 1/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
General disorders Infusion related reaction	0.00% 0/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	8.3% 1/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Investigations Lipase increased	0.00% 0/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	8.3% 1/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Gastrointestinal disorders Nausea	0.00% 0/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	8.3% 1/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	8.3% 1/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Investigations Platelet count decreased	0.00% 0/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	8.3% 1/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Skin and subcutaneous tissue disorders Rash acneiform	0.00% 0/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	8.3% 1/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other	0.00% 0/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	8.3% 1/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Investigations Serum amylase increased	0.00% 0/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	8.3% 1/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Gastrointestinal disorders Stomach pain	0.00% 0/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	8.3% 1/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Nervous system disorders Tremor	0.00% 0/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	8.3% 1/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Gastrointestinal disorders Vomiting	0.00% 0/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	8.3% 1/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Investigations Weight loss	0.00% 0/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	8.3% 1/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.

Other adverse events

Measure	Cohort A: STA-9090 n=13 participants at risk Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort A participants had relapsed \> 60 days following initial chemotherapy completion.	Cohort B: STA-9090 n=12 participants at risk Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort B participants had not responded or had relapsed \</= 60 days from the completion of initial chemotherapy.
Gastrointestinal disorders Abdominal distension	7.7% 1/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	0.00% 0/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Gastrointestinal disorders Abdominal pain	15.4% 2/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	0.00% 0/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Investigations Alanine aminotransferase increased	23.1% 3/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	0.00% 0/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Investigations Alkaline phosphatase increased	7.7% 1/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	8.3% 1/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Immune system disorders Allergic reaction	7.7% 1/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	8.3% 1/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Blood and lymphatic system disorders Anemia	0.00% 0/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	0.00% 0/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Metabolism and nutrition disorders Anorexia	15.4% 2/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	8.3% 1/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Investigations Aspartate aminotransferase increased	15.4% 2/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	16.7% 2/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
General disorders Chills	0.00% 0/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	8.3% 1/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Gastrointestinal disorders Constipation	0.00% 0/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	8.3% 1/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Respiratory, thoracic and mediastinal disorders Cough	7.7% 1/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	0.00% 0/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Metabolism and nutrition disorders Dehydration	15.4% 2/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	0.00% 0/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Gastrointestinal disorders Diarrhea	53.8% 7/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	58.3% 7/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Gastrointestinal disorders Dry mouth	15.4% 2/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	0.00% 0/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Nervous system disorders Dysgeusia	15.4% 2/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	0.00% 0/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Gastrointestinal disorders Dyspepsia	0.00% 0/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	8.3% 1/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Respiratory, thoracic and mediastinal disorders Dyspnea	7.7% 1/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	0.00% 0/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Eye disorders Eye disorders - Other	7.7% 1/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	0.00% 0/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
General disorders Fatigue	15.4% 2/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	25.0% 3/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Vascular disorders Flushing	7.7% 1/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	0.00% 0/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	7.7% 1/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	0.00% 0/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Metabolism and nutrition disorders Hypokalemia	7.7% 1/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	8.3% 1/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Metabolism and nutrition disorders Hypomagnesemia	7.7% 1/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	0.00% 0/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	0.00% 0/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Metabolism and nutrition disorders Hypophosphatemia	7.7% 1/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	16.7% 2/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Infections and infestations Infections and infestations - Other	7.7% 1/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	0.00% 0/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
General disorders Infusion related reaction	0.00% 0/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	8.3% 1/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Investigations Lipase increased	0.00% 0/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	0.00% 0/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Gastrointestinal disorders Nausea	7.7% 1/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	16.7% 2/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Nervous system disorders Peripheral sensory neuropathy	7.7% 1/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	0.00% 0/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Investigations Platelet count decreased	0.00% 0/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	8.3% 1/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Skin and subcutaneous tissue disorders Rash acneiform	0.00% 0/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	8.3% 1/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other	7.7% 1/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	0.00% 0/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Investigations Serum amylase increased	0.00% 0/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	8.3% 1/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Gastrointestinal disorders Stomach pain	0.00% 0/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	8.3% 1/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Nervous system disorders Tremor	7.7% 1/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	0.00% 0/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Gastrointestinal disorders Vomiting	7.7% 1/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	8.3% 1/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.
Investigations Weight loss	7.7% 1/13 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.	0.00% 0/12 • Assessed weekly on treatment from time of first dose and up to day 30 post-treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles. Maximum grade toxicity by type for a patient over time including only events with treatment-attribution of possibly, probably or definitely was first calculated. Serious and Other AEs were defined as events of grades 3-5 and grades 1-2, respectively, based on CTCAEv3 which includes coding events as 'Other'. A patient appears only once for a given type of toxicity. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.

Additional Information

David M. Jackman, MD

Dana-Farber Cancer Institute

Phone: 617.632.3468

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place