A Study of MEK162 (Binimetinib) in Combination With Pexidartinib in Patients With Advanced Gastrointestinal Stromal Tumor (GIST)

A Study of MEK162 (Binimetinib) in Combination With Pexidartinib in Patients With Advanced Gastrointestinal Stromal Tumor (GIST)

Gastrointestinal Stromal Tumor

Active, not recruiting

1

Start Date 04/15/2017

Age of Trial (yrs) 7.6

Gleevec-resistant

KIT/PDGFRA inhibitor + MEK inhibitor

Specifically GIST and only GIST

17-056

Memorial Sloan Kettering Cancer Center

Ping Chi, MD, PhD 646-888-4166 chip@mskcc.org William Tap, MD 646-888-4163

Oral

Brief Summary:
The purpose of this study is to test the safety and tolerability of the combination of pexidartinib and MEK162. This study tests different doses of pexidartinib in combination with different doses of MEK162 to see which dose combination of these drugs is safe and best tolerated in people.

Inclusion Criteria:

Patients must have pathologically confirmed GIST.
In the Phase I dose escalation study, must have locally advanced, unresectable or metastatic GIST and have progressed on imatinib.
In the dose expansion portion of the phase I study, patients must have locally advanced, unresectable or metastatic GIST that is resistant to imatinib. This population includes patients who have not been treated with imatinib (imatinib-naïve) but considered to have primary resistance to imatinib, i.e. KIT/PDGFRA wild-type GIST, and patients with imatinib-refractory disease, i.e. has had prior treatment with imatinib.