A Phase Ib/II Study of MEK162 with Imatinib in Patients with Untreated Advanced Gastrointestinal Stromal Tumor

Protocol
13-162
Full Title
A Phase Ib/II Study of MEK162 in Combination with Imatinib Mesylate in Patients with Untreated Advanced Gastrointestinal Stromal Tumor (GIST)
Phase
I/II
Purpose

Imatinib is used to treat gastrointestinal stromal tumor (GIST). In patients with advanced GIST, the tumors initially shrink with imatinib treatment, but eventually most tumors begin to grow again. MEK162 is an investigational drug that has been shown in laboratory studies to help imatinib block the growth of GIST.

In this study, researchers want to find the highest dose of MEK162 that can be given with imatinib in patients with previously untreated advanced GIST, and to evaluate the effectiveness of this drug combination in advanced GIST. MEK162 inhibits a protein called MEK1/2, which drives cancer growth. Both imatinib and MEK162 are taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have previously untreated advanced GIST.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is open to patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Ping Chi at 646-888-4166 or Dr. William Tap at 646-888-4163.

Disease(s)
Sarcomas: Soft Tissue Sarcoma
Upper Gastrointestinal
Locations
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