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: * Stage 1: 23 patients. If ≥4 patients had clinical benefit, an additional 32 patients were to be enrolled. Up to 3 additional patients with platelet-derived growth factor receptor, alpha polypeptide (PDGFRA) mutation were to be enrolled, regardless of the total study enrollment. * Stage 2: 55 patients. Progressing to this stage was dependent on Stage 1 results. Analyzed: * Stage 1: 27 patients were enrolled and analyzed. The study was not expanded to Stage 2 due to insufficient efficacy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
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.
UCLA Medical Center
Los Angeles, California, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Oregon Health and Science University-Knight Cancer Institute
Portland, Oregon, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
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
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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