Phase 1 Study of Binimetinib Plus Pexidartinib for GIST
Researchers are investigating the safety and tolerability of binimetinib plus pexidartinib among patients with a gastrointestinal stromal tumor.
Title: A Phase I Study of Binimetinib in Combination With Pexidartinib in Patients With Advanced Gastrointestinal Stromal Tumor (GIST)1
Principal Investigators: Ping Chi, MD, PhD, Memorial Sloan Kettering Cancer Center
Description: For this open-label phase 1 study (ClinicalTrials.gov Identifier: NCT03158103), researchers are investigating the safety and tolerability of binimetinib (an MEK inhibitor) plus pexidartinib (a CSF-1R inhibitor) among patients with a GIST.
Patients will receive oral pexidartinib twice daily (400 mg in the morning and 200 mg in the evening) for 2 weeks followed by binimetinib 30 mg twice daily with pexidartinib throughout a 28-day treatment cycle. Varying doses of each medication will be administered.
The primary outcome is to determine the recommended phase 2 dose (RP2D) after 1 year of treatment; the 3+3 format will be used to guide dose escalation based on toxicities observed in the first cycle of therapy. Secondary outcome measures include the number of participants with a complete or partial response.
The estimated study enrollment is 40 patients.
For more study information, including inclusion and exclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/NCT03158103.
Status: Open and recruiting patients as of November 22, 2017.
This study is sponsored by Memorial Sloan Kettering Cancer Center, in collaboration with Array BioPharma and Plexxikon.
- Clinicaltrials.gov. A Study of MEK162 (Binimetinib) in combination with pexidartinib in patients with advanced gastrointestinal stromal tumor (GIST). NCT03158103. https://clinicaltrials.gov/ct2/show/NCT03158103. Accessed November 21, 2017.