NCT01991379

MEK162 in Combination With Imatinib Mesylate in Patients With Untreated Advanced Gastrointestinal Stromal Tumor (GIST)

A Phase Ib/II Study of MEK162 in Combination With Imatinib Mesylate in Patients With Untreated Advanced Gastrointestinal Stromal Tumor (GIST)

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effects, good and/or bad, of MEK162 and imatinib on the patient and on Gastrointestinal Stromal Tumor (GIST). Funding Source - FDA OOPD, Array/Pfizer

Conditions

• Gastrointestinal Stromal Tumor (GIST)

Interventions

Type	Name	Description
DRUG	MEK162	Patients should take the study drug with a glass of water. MEK162 can be taken with or without food.
DRUG	Imatinib Mesylate (Gleevec®; STI571; NSC #716051)
OTHER	Blood draws
PROCEDURE	biopsy	Following informed consent, the first 20 mandatory patients, except for patients who have already been treated with imatinib prior to consent, and subsequent voluntary patients enrolled on the phase II portion of the trial will undergo research biopsies. Patients should hold both imatinib and MEK162 doses on the day they undergo a biopsy.

Timeline

• Start date: 2013-11-01
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2013-11-25
• Last updated: 2025-12-04

Locations

1 site across 1 country: United States