Linsitinib in Treating Patients With Gastrointestinal Stromal Tumors

Linsitinib in Treating Patients With Gastrointestinal Stromal Tumors

Gastrointestinal Stromal Tumor

Completed

2

Start Date 03/15/2012

Age of Trial (yrs) 13.2

Gleevec-resistant

IGF1R inhibitor

Block related tumor signal paths

Specifically GIST plus other cancers

CDR0000728619, SARC-022

Sarcoma Alliance for Research through Collaboration (SARC)

See contact for each trial site.

Oral

This is the first trial of of IGF1R inhibitor for GIST.

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, and then annually thereafter.