Trial · NCT01200238
STA-9090(Ganetespib) in Metastatic Ocular Melanoma
NCT01200238, Phase 2, Completed, Dana-Farber Cancer Institute; results first posted 2018-06-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. STA-9090(Ganetespib) in Metastatic Ocular Melanoma. Trials, record NCT01200238. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01200238
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- STA-9090(Ganetespib) in Metastatic Ocular Melanoma
- NCT number
- NCT01200238
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 17 participants, actual
- Lead sponsor
- Dana-Farber Cancer Institute
- Conditions
- Ocular Melanoma
- Interventions
- STA-9090
- First posted
- 2010-09-13
- Last updated
- 2018-10-18
- Results first posted
- 2018-06-27
- Limitations and caveats
- The study was terminated early due to slow accrual and competing trials.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 4-month Progression Free Survival (PFS) Rate | Disease was evaluated radiologically at baseline and every 8 weeks on treatment; Relevant for this endpoint was status at 4 months. | 4-month PFS rate was defined as the proportion of participants alive, absent progression based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST) and on treatment at 4 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. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. |
| Primary | Expression of cMET | Estimated up to 24 hours after administration of STA-9090 | To estimate the proportion of patients with greater than 50% decrease in expression of HSP90 client protein c-MET 18-24 hours after administration of STA-9090 |
| Secondary | Objective Response Rate (ORR) | Disease was evaluated radiologically at baseline and every 8 weeks on treatment; Median treatment duration was 1.8 months for each cohort [range: cohort A (0.9-12.5), cohort B (0.8-31.7)]. Thus, response on treatment was evaluated up to 31.7 months. | ORR is defined as achieving partial response (PR) or complete response (CR) based on RECIST 1.0 criteria on treatment. Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. CR or PR status required confirmation no earlier than 4 weeks following first documentation. 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. |
| Secondary | Disease Control Rate (DCR) | Disease was evaluated radiologically at baseline and every 8 weeks on treatment; Median treatment duration was 1.8 months for each cohort [range: cohort A (0.9-12.5), cohort B (0.8-31.7)].Thus, response on treatment was evaluated up to 31.7 months. | DCR is defined as achieving stable disease (SD), partial response (P R) or complete response (CR) based on RECIST 1.0 criteria on treatment. Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. CR or PR status required confirmation no earlier than 4 weeks following first documentation. 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. PR or better response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. |
| Secondary | Progression-Free Survival (PFS) | Dz was evaluated every 8 weeks on treatment; Imaging was obtained as clinically indicated until off-study; Median (range) on-study duration (months) was cohort A: 8.7 (3.7 to 28.7) and cohort B: 4.5 (1.2 to 36.4 months). Thus, follow-up was up to 36.4m. | PFS based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study or death. 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. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Participants who did not experience progression were censored at date of last disease evaluation. |
| Secondary | Overall Survival (OS) | Survival follow-up occurred every 4 weeks long-term; Median (range) on-study duration (months) was cohort A: 8.7 (3.7 to 28.7) and cohort B: 4.5 (1.2 to 36.4 months).Thus, follow-up was up to 36.4m. | OS based on the Kaplan-Meier method is defined as the time from study entry to death or date last known alive. |
| Secondary | Grade 3-4 Treatment-Related Toxicity Rate | AE assessment was ongoing from the start of study drug and up to day 30 post-treatment. Mean treatment duration was 1.8 months for each cohort [range: cohort A (0.9-12.5), cohort B (0.8-31.7)). Thus, AEs on treatment were followed up to 31.7 months. | All grade 3-4 adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv4 as reported on case report forms were counted to calculate the proportion of participants experiencing at least one treatment-related grade 3 or 4 AE of any type on treatment. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 4-month Progression Free Survival (PFS) Rate | Disease was evaluated radiologically at baseline and every 8 weeks on treatment; Relevant for this endpoint was status at 4 months. | The analysis dataset is comprised of all enrolled participants. | proportion of participants | NUMBER |
| PRIMARY | Expression of cMET | Estimated up to 24 hours after administration of STA-9090 | There was a problem with the assay and therefore this endpoint was not measured. | ||
| SECONDARY | Objective Response Rate (ORR) | Disease was evaluated radiologically at baseline and every 8 weeks on treatment; Median treatment duration was 1.8 months for each cohort [range: cohort A (0.9-12.5), cohort B (0.8-31.7)]. Thus, response on treatment was evaluated up to 31.7 months. | The analysis dataset is comprised of all enrolled participants. | proportion of participants | NUMBER |
| SECONDARY | Disease Control Rate (DCR) | Disease was evaluated radiologically at baseline and every 8 weeks on treatment; Median treatment duration was 1.8 months for each cohort [range: cohort A (0.9-12.5), cohort B (0.8-31.7)].Thus, response on treatment was evaluated up to 31.7 months. | The analysis dataset is comprised of all enrolled participants. | proportion of participants | NUMBER |
| SECONDARY | Progression-Free Survival (PFS) | Dz was evaluated every 8 weeks on treatment; Imaging was obtained as clinically indicated until off-study; Median (range) on-study duration (months) was cohort A: 8.7 (3.7 to 28.7) and cohort B: 4.5 (1.2 to 36.4 months). Thus, follow-up was up to 36.4m. | The analysis dataset is comprised of all enrolled participants. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Survival follow-up occurred every 4 weeks long-term; Median (range) on-study duration (months) was cohort A: 8.7 (3.7 to 28.7) and cohort B: 4.5 (1.2 to 36.4 months).Thus, follow-up was up to 36.4m. | The analysis dataset is comprised of all enrolled participants. | months | MEDIAN |
| SECONDARY | Grade 3-4 Treatment-Related Toxicity Rate | AE assessment was ongoing from the start of study drug and up to day 30 post-treatment. Mean treatment duration was 1.8 months for each cohort [range: cohort A (0.9-12.5), cohort B (0.8-31.7)). Thus, AEs on treatment were followed up to 31.7 months. | The analysis dataset is comprised of all enrolled participants. | proportion of participants | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 4-month Progression Free Survival (PFS) Rate | STA-9090: Cohort A | 0.059 | 90% Confidence Interval 0.003 to 0.25 | proportion of participants | |
| 4-month Progression Free Survival (PFS) Rate | STA-9090: Cohort B | 0.118 | 90% Confidence Interval 0.021 to 0.326 | proportion of participants | |
| Objective Response Rate (ORR) | STA-9090: Cohort A | 0.0 | 90% Confidence Interval 0.0 to 0.348 | proportion of participants | |
| Objective Response Rate (ORR) | STA-9090: Cohort B | 0.10 | 90% Confidence Interval 0.005 to 0.394 | proportion of participants | |
| Disease Control Rate (DCR) | STA-9090: Cohort A | 0.286 | 90% Confidence Interval 0.054 to 0.659 | proportion of participants | |
| Disease Control Rate (DCR) | STA-9090: Cohort B | 0.30 | 90% Confidence Interval 0.087 to 0.607 | proportion of participants | |
| Progression-Free Survival (PFS) | STA-9090: Cohort A | 1.6 | 90% Confidence Interval 0.8 to 3.5 | months | |
| Progression-Free Survival (PFS) | STA-9090: Cohort B | 1.8 | 90% Confidence Interval 0.9 to 7.1 | months | |
| Overall Survival (OS) | STA-9090: Cohort A | 8.5 | 90% Confidence Interval 3.7 to 28.7 | months | |
| Overall Survival (OS) | STA-9090: Cohort B | 4.9 | 90% Confidence Interval 3.2 to 13.0 | months |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | STA-9090: Cohort A | 7 | |
| Overall Study | STARTED | STA-9090: Cohort B | 10 | |
| Overall Study | COMPLETED | STA-9090: Cohort A | 0 | |
| Overall Study | COMPLETED | STA-9090: Cohort B | 0 | |
| Overall Study | NOT COMPLETED | STA-9090: Cohort A | 7 | |
| Overall Study | NOT COMPLETED | STA-9090: Cohort B | 10 |
Source ClinicalTrials.gov
Adverse events250
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | STA-9090: Cohort A | 1 | 7 | |
| other | Anemia | Blood and lymphatic system disorders | STA-9090: Cohort B | 3 | 10 | |
| other | Left ventricular systolic dysfunction | Cardiac disorders | STA-9090: Cohort A | 0 | 7 | |
| other | Left ventricular systolic dysfunction | Cardiac disorders | STA-9090: Cohort B | 1 | 10 | |
| other | Sinus tachycardia | Cardiac disorders | STA-9090: Cohort A | 0 | 7 | |
| other | Sinus tachycardia | Cardiac disorders | STA-9090: Cohort B | 3 | 10 | |
| other | Ear and labyrinth disorders - Other, specify | Ear and labyrinth disorders | STA-9090: Cohort A | 0 | 7 | |
| other | Ear and labyrinth disorders - Other, specify | Ear and labyrinth disorders | STA-9090: Cohort B | 1 | 10 | |
| other | Blurred vision | Eye disorders | STA-9090: Cohort A | 1 | 7 | |
| other | Blurred vision | Eye disorders | STA-9090: Cohort B | 1 | 10 |
1 to 10 of 250Source ClinicalTrials.gov
See all 250 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | STA-9090: Cohort A | 0 | 7 |
| Total, all-cause mortality | STA-9090: Cohort B | 0 | 10 |
| Total, other adverse events | STA-9090: Cohort A | 7 | 7 |
| Total, other adverse events | STA-9090: Cohort B | 10 | 10 |
| Total, serious adverse events | STA-9090: Cohort A | 2 | 7 |
| Total, serious adverse events | STA-9090: Cohort B | 9 | 10 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| STA-9090: Cohort A vs STA-9090: Cohort B: deaths from any cause | Trial comparisons |
| STA-9090: Cohort A vs STA-9090: Cohort B: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01200238
GET https://conductscience.org/api/trials/v1/NCT01200238/events?page=2