Linsitinib in Treating Patients With Gastrointestinal Stromal Tumors
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|ClinicalTrials.gov Identifier: NCT01560260|
Recruitment Status : Completed
First Posted : March 22, 2012
Results First Posted : January 19, 2017
Last Update Posted : January 19, 2017
|Condition or disease||Intervention/treatment||Phase|
|Carney Complex Chondrosarcoma Gastrointestinal Stromal Tumor Paraganglioma||Other: Laboratory Biomarker Analysis Drug: Linsitinib Other: Pharmacological Study||Phase 2|
I. To determine the response rate to treatment with OSI-906 (linsitinib) 150mg BIO 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of Linsitinib (OSI-906) in Pediatric and Adult Wild Type Gastrointestinal Stromal Tumors|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||October 2015|
Experimental: Treatment (linsitinib)
Patients receive linsitinib 150mg PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
- Response Rate (CR or PR) Using Response Evaluation Criteria in Solid Tumors Guideline Version 1.1 [ Time Frame: At 6 months ]
- Clinical Benefit Rate Defined as SD >= 9 Months, PR or CR [ Time Frame: Up to 2 years ]
- Failure-free Survival [ Time Frame: Up to 37 weeks ]Analyzed using Kaplan-Meier curves for the all treated and per protocol populations.
- OS [ Time Frame: Up to 37 weeks ]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 ]Analyzed using Kaplan-Meier curves for the all treated and per protocol populations.
- Response Duration [ Time Frame: Up to 37 weeks ]Analyzed using Kaplan-Meier curves for the all treated and per protocol populations.
- Time to Progression [ Time Frame: Up to 2 years ]Evaluated using cumulative incidence.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Clinical Center|
|Bethesda, Maryland, United States, 20892|
|United States, Massachusetts|
|Dana-Farber/Harvard Cancer Center|
|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|