Trial · NCT01039519
A Study Evaluating STA-9090 in Patients With Metastatic and/or Unresectable Gastrointestinal Stromal Tumor (GIST)
NCT01039519, Phase 2, Completed, Synta Pharmaceuticals Corp.; results first posted 2016-03-10
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. A Study Evaluating STA-9090 in Patients With Metastatic and/or Unresectable Gastrointestinal Stromal Tumor (GIST). Trials, record NCT01039519. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01039519
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Evaluating STA-9090 in Patients With Metastatic and/or Unresectable Gastrointestinal Stromal Tumor (GIST)
- NCT number
- NCT01039519
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 27 participants, actual
- Lead sponsor
- Synta Pharmaceuticals Corp.
- Conditions
- Gastrointestinal Stromal Tumor
- Interventions
- Ganetespib
- First posted
- 2009-12-25
- Last updated
- 2016-03-10
- Results first posted
- 2016-03-10
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Showing Clinical Benefit Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 | Week 16 up to Week 47 | Clinical benefit is defined as showing a complete response (CR), a partial response (PR) or stable disease (SD) for at least 16 weeks. * CR: disappearance of all target lesions and non-target lesions and no new lesions * PR: at least a 30% decrease in the sum of the longest diameter of target lesions, no disease progression for non-target lesions, and no new lesions * SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, no disease progression for non-target lesions, and no new lesions |
| Secondary | Percentage of Participants Showing an Objective Response Based on RECIST Version 1.0 | Week 16 up to Week 47 | Objective response included participants whose best response with confirmation was a complete response (CR) or partial response (PR) from first dose until progression or end of study. * CR: disappearance of all target lesions and non-target lesions and no new lesions * PR: at least a 30% decrease in the sum of the longest diameter of target lesions, no disease progression for non-target lesions, and no new lesions |
| Secondary | Kaplan-Meier Estimate of Progression Free Survival (PFS) | Day 1 up to Week 47 | PFS was defined as the time from the baseline CT scan to disease progression per RECIST or death for any cause. Progressive disease (PD) was defined as * at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or * the appearance of 1 or more new lesions or * the unequivocal progression of existing nontarget lesions |
| Secondary | Kaplan-Meier Estimate of Overall Survival | Day 1 up to week 97 | Overall survival was defined as the time from first dose to death or the date last known alive. |
| Secondary | Percentage of Participants Showing a Tumor Response During Cycle 1 in Selected Participants Measured by Positron Emission Tomography (PET) | Day 2 to Day 10 | PET imaging was completed on selected patients only from one investigative site. Treatment phase PET and biopsy was completed on any day from Cycle 1 Day 2 through Day 10. PET imaging data were analyzed utilizing the European Organization for Research and Treatment of Cancer (EORTC) PET Study Group guidelines \[Young H, Eur J Cancer, 1999\]. Tumor response was considered a complete response (CR) or a partial response (PR). |
| Secondary | Count of Participants With Treatment-Emergent Adverse Events (AEs) | Day 1 up to Week 51 | Treatment-emergent AEs were defined as AEs that occurred from the time of first dose through 30 days after the last dose of study medication. The Investigator graded the severity of AEs according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria: Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death A Serious AE is defined as any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or constitutes an important medical event. Dose modification includes dose delay and dose reduction. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Showing Clinical Benefit Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 | Week 16 up to Week 47 | Full analysis set which included participants receiving at least one dose of study medication. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Showing an Objective Response Based on RECIST Version 1.0 | Week 16 up to Week 47 | Full analysis set | percentage of participants | NUMBER |
| SECONDARY | Kaplan-Meier Estimate of Progression Free Survival (PFS) | Day 1 up to Week 47 | Full analysis set | months | MEDIAN |
| SECONDARY | Kaplan-Meier Estimate of Overall Survival | Day 1 up to week 97 | Full analysis set | months | MEDIAN |
| SECONDARY | Percentage of Participants Showing a Tumor Response During Cycle 1 in Selected Participants Measured by Positron Emission Tomography (PET) | Day 2 to Day 10 | Participants from one investigative site who provided consent for the PET/CT imaging. | percentage of participants | NUMBER |
| SECONDARY | Count of Participants With Treatment-Emergent Adverse Events (AEs) | Day 1 up to Week 51 | Full analysis set | 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 |
|---|---|---|---|---|---|
| Percentage of Participants Showing Clinical Benefit Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 | Ganetespib 200 mg/m^2 | 18.5 | percentage of participants | ||
| Percentage of Participants Showing an Objective Response Based on RECIST Version 1.0 | Ganetespib 200 mg/m^2 | 0 | percentage of participants | ||
| Kaplan-Meier Estimate of Progression Free Survival (PFS) | Ganetespib 200 mg/m^2 | 1.8 | 95% Confidence Interval 1.6 to 3.5 | months | |
| Kaplan-Meier Estimate of Overall Survival | Ganetespib 200 mg/m^2 | 10.3 | 95% Confidence Interval 5.8 to 13.6 | months | |
| Percentage of Participants Showing a Tumor Response During Cycle 1 in Selected Participants Measured by Positron Emission Tomography (PET) | Ganetespib 200 mg/m^2 | 66.7 | percentage of participants | ||
| Count of Participants With Treatment-Emergent Adverse Events (AEs) | Ganetespib 200 mg/m^2 | >=1 AE | 27 | participants | |
| Count of Participants With Treatment-Emergent Adverse Events (AEs) | Ganetespib 200 mg/m^2 | >=1 AE with severity grade >=3 | 15 | participants | |
| Count of Participants With Treatment-Emergent Adverse Events (AEs) | Ganetespib 200 mg/m^2 | >= 1 SAE | 10 | participants | |
| Count of Participants With Treatment-Emergent Adverse Events (AEs) | Ganetespib 200 mg/m^2 | >=1 AE leading to dose modification | 10 | participants | |
| Count of Participants With Treatment-Emergent Adverse Events (AEs) | Ganetespib 200 mg/m^2 | >=1 AE leading to dose interruption | 1 | participants |
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 |
|---|---|---|---|---|
| Treatment | STARTED | Ganetespib 200 mg/m^2 | 27 | |
| Treatment | COMPLETED | Ganetespib 200 mg/m^2 | 0 | |
| Treatment | NOT COMPLETED | Ganetespib 200 mg/m^2 | 27 | |
| Survival Follow-up | STARTED | Ganetespib 200 mg/m^2 | 27 | |
| Survival Follow-up | COMPLETED | Ganetespib 200 mg/m^2 | 0 | |
| Survival Follow-up | NOT COMPLETED | Ganetespib 200 mg/m^2 | 27 |
Source ClinicalTrials.gov
Adverse events157
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 | Anaemia | Blood and lymphatic system disorders | Ganetespib 200 mg/m^2 | 9 | 27 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Ganetespib 200 mg/m^2 | 2 | 27 | |
| other | Leukopenia | Blood and lymphatic system disorders | Ganetespib 200 mg/m^2 | 1 | 27 | |
| other | Neutropenia | Blood and lymphatic system disorders | Ganetespib 200 mg/m^2 | 1 | 27 | |
| other | Tachycardia | Cardiac disorders | Ganetespib 200 mg/m^2 | 3 | 27 | |
| other | Arrhythmia superventribular | Cardiac disorders | Ganetespib 200 mg/m^2 | 1 | 27 | |
| other | Ear discomfort | Ear and labyrinth disorders | Ganetespib 200 mg/m^2 | 1 | 27 | |
| other | Eye pain | Eye disorders | Ganetespib 200 mg/m^2 | 1 | 27 | |
| other | Vision blurred | Eye disorders | Ganetespib 200 mg/m^2 | 1 | 27 | |
| other | Diarrhoea | Gastrointestinal disorders | Ganetespib 200 mg/m^2 | 22 | 27 |
1 to 10 of 157Source ClinicalTrials.gov
See all 157 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ganetespib 200 mg/m^2 | ||
| Total, other adverse events | Ganetespib 200 mg/m^2 | 27 | 27 |
| Total, serious adverse events | Ganetespib 200 mg/m^2 | 10 | 27 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01039519
GET https://conductscience.org/api/trials/v1/NCT01039519/events?page=2