TRIAL DETAIL

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

Drug:
Trial Name:
MEK162 in Combination With Imatinib Mesylate in Patients With Untreated Advanced Gastrointestinal Stromal Tumor (GIST)
NCT#:
Conditions:
Gastrointestinal Stromal Tumor
Status:
Recruiting
Phase:
2
Start Date 11/01/2013
Age of Trial (yrs) 5.9
Treatment Phase:
Gleevec-resistant
Drug Category:
KIT/PDGFRA inhibitor + MEK inhibitor
Strategy:
Block KIT + Block KIT Signal Path
Trial Type:
Specifically GIST and only GIST
Other Protocol IDs:
13-162 R01FD005731 ( U.S. FDA Grant/Contract )
Sponsor:
Memorial Sloan-Kettering Cancer Center
Patient Contact:
Ping Chi, MD 646-888-3338 William Tap, MD 646-888-4163
Contact email:
Contact Phone:
Randomized:
IV or Oral:
Oral
Trial Notes:
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.

We have listed it as Phase 2 because of the age of the trial and the likelihood that it is now in Phase 2.

"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."


Collaborators include the University of Pittsburgh

Trial Links

 
 

Trial Results

Drug Information

Trial Sites

Name
Address
City
State
Zip
Country
1275 York Ave
New York
NY
10065
USA