Trial Outcomes & Findings for STA-9090(Ganetespib) in Patients With Unresectable Stage III or Stage IV Melanoma (NCT NCT01551693)
NCT ID: NCT01551693
Last Updated: 2017-04-12
Results Overview
6-month progression-free survival rate was defined as the proportion of patients absent death or progression based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST) before 6 months. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
3 participants
Primary outcome timeframe
Disease was evaluated radiologically at baseline and every 8 weeks on treatment; Treatment continued until evidence of disease progression or unacceptable toxicity. Relevant for this endpoint was disease status at 6 months.
Results posted on
2017-04-12
Participant Flow
Patients enrolled from September 2011 to March 2012.
Participant milestones
| Measure |
STA-9090 Cohort A
Patients enrolled into two possible cohorts based on tumor expression of BRAF: Cohort A - BRAF mutant disease or Cohort B - BRAF wild type. Cohort A patients received STA-9090 200 mg/m2 once weekly (d1, 8, 15 of 28 day cycle). Patients were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
|
STA-9090 Cohort B
Patients enrolled into two possible cohorts based on tumor expression of BRAF: Cohort A - BRAF mutant disease or Cohort B - BRAF wild type. Cohort B patients received STA-9090 150 mg/m2 twice weekly (d1, 4, 8, 11, 15, 18 of 28 day cycle). Patients were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
STA-9090 Cohort A
Patients enrolled into two possible cohorts based on tumor expression of BRAF: Cohort A - BRAF mutant disease or Cohort B - BRAF wild type. Cohort A patients received STA-9090 200 mg/m2 once weekly (d1, 8, 15 of 28 day cycle). Patients were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
|
STA-9090 Cohort B
Patients enrolled into two possible cohorts based on tumor expression of BRAF: Cohort A - BRAF mutant disease or Cohort B - BRAF wild type. Cohort B patients received STA-9090 150 mg/m2 twice weekly (d1, 4, 8, 11, 15, 18 of 28 day cycle). Patients were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
|
|---|---|---|
|
Overall Study
Disease Progression
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
STA-9090(Ganetespib) in Patients With Unresectable Stage III or Stage IV Melanoma
Baseline characteristics by cohort
| Measure |
STA-9090 Cohort A
n=1 Participants
Patients enrolled into two possible cohorts based on tumor expression of BRAF: Cohort A - BRAF mutant disease or Cohort B - BRAF wild type. Cohort A patients received STA-9090 200 mg/m2 once weekly (d1, 8, 15 of 28 day cycle). Patients were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
|
STA-9090 Cohort B
n=2 Participants
Patients enrolled into two possible cohorts based on tumor expression of BRAF: Cohort A - BRAF mutant disease or Cohort B - BRAF wild type. Cohort B patients received STA-9090 150 mg/m2 twice weekly (d1, 4, 8, 11, 15, 18 of 28 day cycle). Patients were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60 years
n=93 Participants
|
75 years
n=4 Participants
|
71 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=93 Participants
|
2 participants
n=4 Participants
|
3 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Disease was evaluated radiologically at baseline and every 8 weeks on treatment; Treatment continued until evidence of disease progression or unacceptable toxicity. Relevant for this endpoint was disease status at 6 months.6-month progression-free survival rate was defined as the proportion of patients absent death or progression based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST) before 6 months. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.
Outcome measures
| Measure |
STA-9090 Cohort A
n=1 Participants
Patients enrolled into two possible cohorts based on tumor expression of BRAF: Cohort A - BRAF mutant disease or Cohort B - BRAF wild type. Cohort A patients received STA-9090 200 mg/m2 once weekly (d1, 8, 15 of 28 day cycle). Patients were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
|
STA-9090 Cohort B
n=2 Participants
Patients enrolled into two possible cohorts based on tumor expression of BRAF: Cohort A - BRAF mutant disease or Cohort B - BRAF wild type. Cohort B patients received STA-9090 150 mg/m2 twice weekly (d1, 4, 8, 11, 15, 18 of 28 day cycle). Patients were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
|
|---|---|---|
|
6-month Progression-Free Survival Rate
|
0.0 proportion of participants
|
0.0 proportion of participants
|
SECONDARY outcome
Timeframe: Disease was evaluated radiologically at baseline and every 8 weeks on treatment. Median (range) treatment duration was 1 cycle/4 weeks (1-2 cycles; 4-8 weeks).Best overall response (BOR) on treatment was based on RECIST 1.0 criteria. For target lesions, complete response (CR) is complete disappearance of all target lesions and partial response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. CR or PR confirmation required within 4 weeks. Progressive disease (PD) is at least a 20% increase in the sum LD of target lesions from smallest sum LD as reference or the appearance of one or more new lesions. Stable disease (SD) is neither meeting PR or PD. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. CR is disappearance of all non-target lesions.
Outcome measures
| Measure |
STA-9090 Cohort A
n=1 Participants
Patients enrolled into two possible cohorts based on tumor expression of BRAF: Cohort A - BRAF mutant disease or Cohort B - BRAF wild type. Cohort A patients received STA-9090 200 mg/m2 once weekly (d1, 8, 15 of 28 day cycle). Patients were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
|
STA-9090 Cohort B
n=2 Participants
Patients enrolled into two possible cohorts based on tumor expression of BRAF: Cohort A - BRAF mutant disease or Cohort B - BRAF wild type. Cohort B patients received STA-9090 150 mg/m2 twice weekly (d1, 4, 8, 11, 15, 18 of 28 day cycle). Patients were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
|
|---|---|---|
|
Best Overall Response
Unevaluable
|
0 participants
|
1 participants
|
|
Best Overall Response
Progressive Disease
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Patients were followed every 4 weeks for survival until death, lost to follow-up or study closure (approximately 6 months after the last patient ended treatment). In this study cohort, patients were followed up to 13 weeks.Population: Overall survival was not estimated given the limited sample size.
Overall survival is defined as the time from study entry to death or date last known alive and estimated using Kaplan-Meier (KM) methods.
Outcome measures
Outcome data not reported
Adverse Events
STA-9090 Cohort A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
STA-9090 Cohort B
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
STA-9090 Cohort A
n=1 participants at risk
Patients enrolled into two possible cohorts based on tumor expression of BRAF: Cohort A - BRAF mutant disease or Cohort B - BRAF wild type. Cohort A patients received STA-9090 200 mg/m2 once weekly (d1, 8, 15 of 28 day cycle). Patients were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
|
STA-9090 Cohort B
n=2 participants at risk
Patients enrolled into two possible cohorts based on tumor expression of BRAF: Cohort A - BRAF mutant disease or Cohort B - BRAF wild type. Cohort B patients received STA-9090 150 mg/m2 twice weekly (d1, 4, 8, 11, 15, 18 of 28 day cycle). Patients were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
|
|---|---|---|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/1 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment. Mean treatment duration was 1 cycle/4 weeks (range 1-2 cycles/4-8 weeks).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
50.0%
1/2 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment. Mean treatment duration was 1 cycle/4 weeks (range 1-2 cycles/4-8 weeks).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/1 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment. Mean treatment duration was 1 cycle/4 weeks (range 1-2 cycles/4-8 weeks).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
50.0%
1/2 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment. Mean treatment duration was 1 cycle/4 weeks (range 1-2 cycles/4-8 weeks).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
Other adverse events
| Measure |
STA-9090 Cohort A
n=1 participants at risk
Patients enrolled into two possible cohorts based on tumor expression of BRAF: Cohort A - BRAF mutant disease or Cohort B - BRAF wild type. Cohort A patients received STA-9090 200 mg/m2 once weekly (d1, 8, 15 of 28 day cycle). Patients were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
|
STA-9090 Cohort B
n=2 participants at risk
Patients enrolled into two possible cohorts based on tumor expression of BRAF: Cohort A - BRAF mutant disease or Cohort B - BRAF wild type. Cohort B patients received STA-9090 150 mg/m2 twice weekly (d1, 4, 8, 11, 15, 18 of 28 day cycle). Patients were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/1 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment. Mean treatment duration was 1 cycle/4 weeks (range 1-2 cycles/4-8 weeks).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
50.0%
1/2 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment. Mean treatment duration was 1 cycle/4 weeks (range 1-2 cycles/4-8 weeks).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/1 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment. Mean treatment duration was 1 cycle/4 weeks (range 1-2 cycles/4-8 weeks).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
50.0%
1/2 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment. Mean treatment duration was 1 cycle/4 weeks (range 1-2 cycles/4-8 weeks).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/1 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment. Mean treatment duration was 1 cycle/4 weeks (range 1-2 cycles/4-8 weeks).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
50.0%
1/2 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment. Mean treatment duration was 1 cycle/4 weeks (range 1-2 cycles/4-8 weeks).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/1 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment. Mean treatment duration was 1 cycle/4 weeks (range 1-2 cycles/4-8 weeks).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
50.0%
1/2 • AE assessment was ongoing from the start of study drug and up to day 30 post-treatment. Mean treatment duration was 1 cycle/4 weeks (range 1-2 cycles/4-8 weeks).
Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place