Clinical Trial: Linsitinib in Treating Patients With Gastrointestinal Stromal Tumors

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 2 Study of Linsitinib (OSI-906) in Pediatric and Adult Wild Type Gastrointestinal Stromal Tumors

Brief Summary: 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.

Detailed Summary:

PRIMARY OBJECTIVES:

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).

SECONDARY OBJECTIVES:

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
Sponsor: National Cancer Institute (NCI)

Current Primary Outcome: Response Rate (CR or PR) Using Response Evaluation Criteria in Solid Tumors Guideline Version 1.1 [ Time Frame: At 6 months ]

Original Primary Outcome: Response rate (CR or PR) at 6 months

Current Secondary Outcome:

  • 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.


Original Secondary Outcome:

  • Clinical benefit rate defined as SD ≥ 9 months
  • Response duration, PFS, overall survival, and failure-free survival up to 37 weeks of treatment using Kaplan-Meier curves
  • Adverse event profile of OSI-906 in an ongoing basis


Information By: National Cancer Institute (NCI)

Dates:
Date Received: March 20, 2012
Date Started: March 2012
Date Completion:
Last Updated: November 18, 2016
Last Verified: November 2016