Linsitinib in Treating Patients With 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.
Gastrointestinal Stromal Tumor
Other: Pharmacological Study
Other: Laboratory Biomarker Analysis
|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 ]
- 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.
- 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.
- 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.
- 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.
- Time to progression [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]Evaluated using cumulative incidence.
|Study Start Date:||March 2012|
|Primary Completion Date:||December 2013 (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 Names:Other: Pharmacological Study
Other Name: pharmacological studiesOther: Laboratory Biomarker Analysis
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 University Hospitals and Clinics|
|Stanford, California, United States, 94305|
|United States, Iowa|
|University of Iowa Hospitals and Clinics|
|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|
|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|