Linsitinib in Treating Patients With Gastrointestinal Stromal Tumors

Summary

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Description

PRIMARY OBJECTIVES: I. To determine the response rate to treatment with OSI-906 (linsitinib) 150mg BID in patients with advanced wild-type (WT) gastrointestinal stromal tumor (GIST). SECONDARY OBJECTIVES: I. To determine the clinical benefit rate (CBR) (stable disease [SD] >= 9 months, partial respo...

PRIMARY OBJECTIVES: I. To determine the response rate to treatment with OSI-906 (linsitinib) 150mg BID in patients with advanced wild-type (WT) gastrointestinal stromal tumor (GIST). SECONDARY OBJECTIVES: I. To determine the clinical benefit rate (CBR) (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 (PFS), and overall survival (OS) 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. OUTLINE: 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.

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