Linsitinib in Treating Patients With Gastrointestinal Stromal Tumors
Gastrointestinal Stromal Tumor
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 2 Study of Linsitinib (OSI-906) in Pediatric and Adult Wild Type Gastrointestinal Stromal Tumors|
- Response rate (CR or PR) using Response Evaluation Criteria in Solid Tumors guideline version 1.1 [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
- Clinical benefit rate defined as SD >= 9 months, PR or CR [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
- Failure-free survival [ Time Frame: Up to 37 weeks ] [ Designated as safety issue: No ]Analyzed using Kaplan-Meier curves for the all treated and per protocol populations.
- OS [ Time Frame: Up to 37 weeks ] [ Designated as safety issue: No ]Analyzed using Kaplan-Meier curves for the all treated and per protocol populations.
- PFS [ Time Frame: Time from date of enrollment to time of progression or death due to any cause, assessed up to 37 weeks ] [ Designated as safety issue: No ]Analyzed using Kaplan-Meier curves for the all treated and per protocol populations.
- Response duration [ Time Frame: Up to 37 weeks ] [ Designated as safety issue: No ]Analyzed using Kaplan-Meier curves for the all treated and per protocol populations.
- Time to progression [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]Evaluated using cumulative incidence.
|Study Start Date:||March 2012|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Experimental: Treatment (linsitinib)
Patients receive linsitinib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
Correlative studiesDrug: Linsitinib
Other Names:Other: Pharmacological Study
I. To determine the response rate to treatment with OSI-906 (linsitinib) in patients with advanced wild-type (WT) gastrointestinal stromal tumor (GIST).
I. To determine the clinical benefit rate (stable disease [SD] >= 9 months, partial response [PR], or complete response [CR]) in patients with advanced WT GIST treated with OSI-906.
II. To determine the response duration, progression free survival, and overall survival in patients with advanced WT GIST treated with OSI-906.
III. To determine the tolerability and adverse event profile of OSI-906 in patients with advanced GIST.
IV. To explore patterns of protein expression in serum and tumor tissues as predictors of response and progression-free survival (PFS) in advanced WT GIST treated with OSI-906.
V. To evaluate the metabolic response to OSI-906 using fludeoxyglucose F 18 (FDG)-positron emission tomography (PET).
VI. To determine if tumor metabolic response correlates with anatomic response and clinical benefit.
VII. To measure changes in tumor metabolism by FDG-PET qualitatively and semi-quantitatively with standard uptake value (SUV) and tumor body ratio (TBR) from baseline to first computed tomography (CT)-response evaluation and correlate the findings with size changes as defined by conventional cross-sectional imaging scans.
VIII. To investigate correlations between glucose, insulin, and candidate tumor tissue and blood biomarkers with FDG-PET metabolic response.
Patients receive linsitinib orally (PO) twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days, every 12 weeks for 2 years, and then annually thereafter.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01560260
|United States, California|
|Stanford Cancer Institute|
|Palo Alto, California, United States, 94304|
|United States, Iowa|
|University of Iowa/Holden Comprehensive Cancer Center|
|Iowa City, Iowa, United States, 52242|
|United States, Maryland|
|National Institutes of Health|
|Bethesda, Maryland, United States, 20892|
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|United States, Michigan|
|Sarcoma Alliance for Research Through Collaboration|
|Ann Arbor, Michigan, United States, 48106|
|University of Michigan Comprehensive Cancer Center|
|Ann Arbor, Michigan, United States, 48109|
|United States, Oregon|
|Oregon Health and Science University|
|Portland, Oregon, United States, 97239|
|United States, Pennsylvania|
|Fox Chase Cancer Center|
|Philadelphia, Pennsylvania, United States, 19111|
|Principal Investigator:||Margaret von Mehren||Sarcoma Alliance for Research through Collaboration|