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

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

Gastrointestinal Stromal Tumor

Active, not recruiting

1b/2

Start Date 11/01/2013

Age of Trial (yrs) 11.5

Gleevec-resistant First-line

KIT/PDGFRA inhibitor + MEK inhibitor

Block KIT + Block KIT Signal Path

Specifically GIST and only GIST

13-162 R01FD005731 ( U.S. FDA Grant/Contract )

Memorial Sloan-Kettering Cancer Center

Ping Chi, MD 646-888-3338 William Tap, MD 646-888-4163

Oral

This trial will test a new drug that uses a MEK inhibitor to target ETV1 in combination with imatinib on a small group of newly diagnosed GIST patients with advanced disease.
The trial is different because most new GIST clinical trials recruit patients that already have taken imatinib, sunitinib or other drugs and have already developed resistance to those drugs. This trial will try to show that treatment with a combination of imatinib and the MEK inhibitor from the start will be even more effective in combating GIST and will reduce the likelihood of secondary mutations that cause resistance.
The trial does have two different "phases"; Phase 1 for patients that have failed imatinib and Phase 2 for patients that have never had or never failed imatinib.



"Exclusion Criteria:

In the phase II portion of the study, patients that have been previously treated with any systemic therapy for GIST are not permitted to enroll, with the exception of adjuvant imatinib systemic therapy or exposure to imatinib within 4 weeks of signing consent."