A Phase 2 Study of OSI-906 in Patients With Pediatric and Adult Wild Type Gastrointestinal Stromal Tumors
- To determine the response rate (complete response [CR] and partial response [PR]) to
treatment with linsitinib (OSI-906) in patients with advanced wild-type (WT)
gastrointestinal stromal tumor (GIST) as determined by Response Evaluation Criteria in
Solid Tumors (RECIST) 1.1.
- To determine the clinical benefit rate (stable disease [SD] ≥ 9 months, PR, or CR) in
patients with advanced WT GIST treated with linsitinib.
- To determine the response duration, progression-free survival (PFS), and overall
survival in patients with advanced WT GIST treated with linsitinib.
- To determine the tolerability and adverse event profile of linsitinib in patients with
- To explore patterns of protein expression in serum and tumor tissues as predictors of
response and PFS in advanced WT GIST treated with linsitinib.
- To evaluate the metabolic response to linsitinib using fludeoxyglucose F 18
(FDG)-positron emission tomography (PET).
- To determine if tumor metabolic response correlates with anatomic response and clinical
- 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. (exploratory)
- To investigate correlations between glucose, insulin, and candidate tumor tissue and
blood biomarkers with FDG-PET metabolic response. (exploratory)
OUTLINE: This is a multicenter study. Patients are stratified according to type of
gastrointestinal stromal tumor (GIST): Pediatric wild-type (WT) GIST: diagnosed at a young
age (< 18) or having characteristics consistent with Carney triad of Carney-Stretakis
syndrome vs Adult WT GIST: all others.
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.
Patients undergo blood sample collection at baseline and periodically during treatment for
biomarker studies. Tumor tissue samples from biopsy or time of relapse may also be collected
for correlative studies.
After completion of study treatment, patients are followed up for 30 days, every 12 weeks
for 2 years (from date of first dose of linsitinib), and then annually thereafter.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate (CR or PR) at 6 months
Margaret von Mehren, MD
Fox Chase Cancer Center
United States: Food and Drug Administration
|University of Michigan Comprehensive Cancer Center||Ann Arbor, Michigan 48109-0752|
|Fox Chase Cancer Center - Philadelphia||Philadelphia, Pennsylvania 19111-2497|
|Oregon Health and Science University||Portland, Oregon 97201|
|Stanford Comprehensive Cancer Center||Stanford, California 94305|
|Dana Farber||Boston, Massachusetts 02115-6084|