TRIAL DETAIL

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

Drug:
Trial Name:
A Study of MEK162 (Binimetinib) in Combination With Pexidartinib in Patients With Advanced Gastrointestinal Stromal Tumor (GIST)
NCT#:
Conditions:
Gastrointestinal Stromal Tumor
Status:
Active, not recruiting
Phase:
1
Start Date 04/15/2017
Age of Trial (yrs) 5.2
Treatment Phase:
Gleevec-resistant
Drug Category:
KIT/PDGFRA inhibitor + MEK inhibitor
Strategy:
Trial Type:
Specifically GIST and only GIST
Other Protocol IDs:
17-056
Sponsor:
Memorial Sloan Kettering Cancer Center
Patient Contact:
Ping Chi, MD, PhD 646-888-4166 chip@mskcc.org William Tap, MD 646-888-4163
Contact email:
Contact Phone:
Randomized:
IV or Oral:
Oral
Trial Notes:
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.

Trial Links

Trial Results

Drug Information

Trial Sites

Name
Address
City
State
Zip
Country
1275 York Ave
New York
NY
10065
USA