A Phase 2 interventional study of Ganetespib in Gastrointestinal Stromal Tumor, sponsored by Synta Pharmaceuticals Corp.. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-03-10.
Sponsored by Synta Pharmaceuticals Corp. · Phase 2, Interventional, and Treatment
The purpose of this study is to determine if STA-9090 is effective in the treatment of patients with metastatic and/or unresectable GIST.
Planned:
Analyzed:
333 studies on the registry are indexed under Gastrointestinal Stromal Tumors; 61 are open to participants now.
This study's enrollment of 27 is below the median of 50 across 243 interventional studies indexed under Gastrointestinal Stromal Tumors.
Browse Gastrointestinal Stromal Tumors studies →Synta Pharmaceuticals Corp. is the lead sponsor of 24 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Ganetespib (STA-9090) 200 mg/m\^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.
Drug: Ganetespib
Ganetespib 200 mg/m\^2 during an approximately 1-hour infusion once weekly for three consecutive weeks followed by a treatment-free week. Participants who demonstrate acceptable tolerability and objective clinical benefit (defined by at least stable disease or objective response per RECIST) can continue to receive ganetespib until disease progression or appearance of unacceptable toxicity.
Also known as: STA-9090
Percentage of Participants Showing Clinical Benefit Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0
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
Time frame: Week 16 up to Week 47
Percentage of Participants Showing an Objective Response Based on RECIST Version 1.0
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
Time frame: Week 16 up to Week 47
Kaplan-Meier Estimate of Progression Free Survival (PFS)
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
Time frame: Day 1 up to Week 47
Kaplan-Meier Estimate of Overall Survival
Overall survival was defined as the time from first dose to death or the date last known alive.
Time frame: Day 1 up to week 97
Percentage of Participants Showing a Tumor Response During Cycle 1 in Selected Participants Measured by Positron Emission Tomography (PET)
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).
Time frame: Day 2 to Day 10
Count of Participants With Treatment-Emergent Adverse Events (AEs)
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.
Time frame: Day 1 up to Week 51
| Milestone | Ganetespib 200 mg/m^2 |
|---|---|
| Started | 27 |
| Completed | 0 |
| Not completed | 27 |
| Withdrew: Progressive disease | 20 |
| Withdrew: Treatment failure | 2 |
| Withdrew: Adverse event | 3 |
| Withdrew: Physician decision | 2 |
| Milestone | Ganetespib 200 mg/m^2 |
|---|---|
| Started | 27 |
| Completed | 0 |
| Not completed | 27 |
| Withdrew: Death | 23 |
| Withdrew: Sponsor decision | 4 |
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
| percentage of participants | Ganetespib 200 mg/m^2 |
|---|---|
| Percentage of Participants Showing Clinical Benefit Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 | 18.5 |
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
| percentage of participants | Ganetespib 200 mg/m^2 |
|---|---|
| Percentage of Participants Showing an Objective Response Based on RECIST Version 1.0 | 0 |
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
| months | Ganetespib 200 mg/m^2 |
|---|---|
| Kaplan-Meier Estimate of Progression Free Survival (PFS) | 1.8 (1.6 to 3.5) |
Overall survival was defined as the time from first dose to death or the date last known alive.
| months | Ganetespib 200 mg/m^2 |
|---|---|
| Kaplan-Meier Estimate of Overall Survival | 10.3 (5.8 to 13.6) |
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).
| percentage of participants | Ganetespib 200 mg/m^2 |
|---|---|
| Percentage of Participants Showing a Tumor Response During Cycle 1 in Selected Participants Measured by Positron Emission Tomography (PET) | 66.7 |
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.
| participants | Ganetespib 200 mg/m^2 |
|---|---|
| >=1 AE | 27 |
| >=1 AE with severity grade >=3 | 15 |
| >= 1 SAE | 10 |
| >=1 AE leading to dose modification | 10 |
| >=1 AE leading to dose interruption | 1 |
| >=1 AE leading to study drug discontinuation | 3 |
| >=1 AE with an outcome of death | 1 |
Collected over Day 1 up to Week 51. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ganetespib 200 mg/m^2 | — | 10/27 (37%) | 27/27 (100%) |
| Event | Ganetespib 200 mg/m^2 |
|---|---|
| AnaemiaBlood and lymphatic system disorders | 2/27 |
| Abdominal painGastrointestinal disorders | 2/27 |
| Colonic fistulaGastrointestinal disorders | 1/27 |
| Gastrointestinal haemorrhageGastrointestinal disorders | 1/27 |
| IntussusceptionGastrointestinal disorders | 1/27 |
| NauseaGastrointestinal disorders | 1/27 |
| Oesophageal ulcerGastrointestinal disorders | 1/27 |
| VomitingGastrointestinal disorders | 1/27 |
| Hepatic painHepatobiliary disorders | 1/27 |
| InfectionInfections and infestations | 1/27 |
| Event | Ganetespib 200 mg/m^2 |
|---|---|
| DiarrhoeaGastrointestinal disorders | 22/27 |
| FatigueGeneral disorders | 15/27 |
| NauseaGastrointestinal disorders | 13/27 |
| VomitingGastrointestinal disorders | 10/27 |
| HeadacheNervous system disorders | 10/27 |
| AnaemiaBlood and lymphatic system disorders | 9/27 |
| InsomniaPsychiatric disorders | 8/27 |
| ConstipationGastrointestinal disorders | 7/27 |
| Blood alkaline phosphatase increasedInvestigations | 7/27 |
| Abdominal distensionGastrointestinal disorders | 6/27 |
Full analysis set, which includes participants given at least one dose of study medication.
| Age, Continuous(years) | Ganetespib 200 mg/m^2 |
|---|---|
| Mean | 54.4 ± 8.35 |
| Sex: Female, Male(Participants) | Ganetespib 200 mg/m^2 |
|---|---|
| Female | 12 |
| Male | 15 |
| Ethnicity (NIH/OMB)(Participants) | Ganetespib 200 mg/m^2 |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 27 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Ganetespib 200 mg/m^2 |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 4 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 21 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Weight(kg) | Ganetespib 200 mg/m^2 |
|---|---|
| Mean | 74.94 ± 22.095 |
| Height(cm) | Ganetespib 200 mg/m^2 |
|---|---|
| Mean | 171.57 ± 10.295 |
| Body Surface Area (BSA)(m^2) | Ganetespib 200 mg/m^2 |
|---|---|
| Mean | 1.863 ± 0.2909 |
| Time from Initial Gastrointestinal Stromal Tumor (GIST) Diagnosis to Consent(months) | Ganetespib 200 mg/m^2 |
|---|---|
| Mean | 68.71 ± 34.699 |
6 further baseline measures are reported on the registry.
This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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Gastrointestinal Stromal Tumors→
Synta Pharmaceuticals Corp.