Title: A Phase Ib/II Study of MEK162 in Combination With Imatinib Mesylate in Patients With Untreated Advanced Gastrointestinal Stromal Tumor (GIST)1
Principal Investigator: Ping Chi, MD, PhD, Memorial Sloan Kettering Cancer Center
Description: For this phase 1b/2 interventional study, researchers are investigating the safety and efficacy of MEK162 plus imatinib among patients with gastrointestinal stromal tumors (GIST).
For the phase 1b portion of the study, eligible patients must have locally advanced or metastatic GIST and must have progressed on imatinib.
Patients in the phase 1b portion of the study will receive imatinib 400 mg once daily plus MEK162 at standard 3+3 escalation doses, and in the phase 1b expansion will receive MEK162 30 mg twice daily and imatinib 400 mg once daily.
For the phase 2 portion of the study, eligible patients must have newly diagnosed GIST, be treatment-naive, or have received the last dose of adjuvant imatinib therapy at least 3 months prior to enrolment.
Phase 2 patients will receive imatinib 400 mg once daily plus MEK162 30 mg twice daily.
The primary outcome for the phase 1b portion of the study is maximum tolerated dose and for the phase 2 portion is best response rate assessed within 32 weeks of treatment. Secondary measures are response rate and progression-free survival.
The estimated enrollment is 62.
For more study information, including inclusion and exclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/NCT01991379.
Status: This study is open and recruiting patients as of September 26, 2017.
This study is sponsored by Memorial Sloan Kettering Cancer Center in collaboration with Array BioPharma and the University of Pittsburgh.
- Clinicaltrials.gov. MEK162 in combination with imatinib mesylate in patients with untreated advanced gastrointestinal stromal tumor (GIST). NCT01991379. https://clinicaltrials.gov/ct2/show/NCT01991379. Accessed September 26, 2017.