Gastrointestinal Stromal Tumor Clinical Trial
Official title:
A Phase 2 Study of Linsitinib (OSI-906) in Pediatric and Adult Wild Type Gastrointestinal Stromal Tumors
This phase II trial studies how well linsitinib works in treating younger and adult patients with gastrointestinal stromal tumors. Linsitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
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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