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Pexidartinib will be administered orally by the patients on a twice daily basis throughout the treatment cycle. Pexidartinib is available in 200mg tablets. MEK162 wiIl be administered orally on a twice daily basis throughout the treatment cycle. MEK162 is available in 15mg tablets. In this phase I study all patients will have a 2-week lead in of pexidartinib therapy alone. Thereafter, pexidartinib will be administered in combination with MEK162 on a consecutive daily basis. A treatment cycle consists of 28 days. In the dose escalation portion the dose of pexidartinib and MEK 162 will depend on the dose level cohort onto which the patient is enrolled.

MEK162

pexidartinib 600mg daily (400mg in the morning, 200mg at night) for 4 weeks (1 cycle)

Pexidartinib

Ping Chi, MD, PhD

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.

The phase I study consists of a dose-escalation cohort and a dose-expansion cohort.

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

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

The dose escalation study will be pursued in standard 3+3 format, based on toxicities encountered during the first cycle of therapy.

Array BioPharma

Plexxikon

Memorial Sloan Kettering Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of MEK162 (Binimetinib) in Combination With Pexidartinib in Patients With Advanced Gastrointestinal Stromal Tumor (GIST)	NCT03158103	Gastrointestina...	MEK162 Pexidartinib	18 Years -	Memorial Sloan Kettering Cancer Center
A Study of MEK162 (Binimetinib) in Combination With Pexidartinib in Patients With Advanced Gastrointestinal Stromal Tumor (GIST)	NCT03158103	Gastrointestina...	MEK162 Pexidartinib	18 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for mek162 (binimetinib)