MEK162 + Imatinib for Gastrointestinal Stromal Tumor

Recruiting in Palo Alto (17 mi)

Overseen byPing Chi

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?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

Eligibility Criteria

Adults with confirmed Gastrointestinal Stromal Tumor (GIST) who can take pills, have not been treated before or are off previous treatment for 3 months. They must be in good health based on specific blood tests and heart function, agree to use birth control if necessary, and cannot have a history of certain eye diseases, uncontrolled medical conditions like diabetes or hypertension, recent major surgery side effects, or active infections.

Inclusion Criteria

My diagnosis is a gastrointestinal stromal tumor (GIST).

My GIST has worsened despite taking imatinib.

I am newly diagnosed with GIST or haven't taken imatinib for 3+ months.

+8 more

Exclusion Criteria

I have had serious heart issues or procedures in the last 6 months.

My high blood pressure is not controlled despite taking medication.

I have a muscle disorder that causes high levels of an enzyme in my blood.

+15 more

Participant Groups

The trial is testing the combination of two drugs: MEK162 and Imatinib Mesylate (Gleevec), which patients will take orally. The study aims to see how well these drugs work together against untreated advanced GIST by monitoring their effects through biopsies and regular blood draws.

1Treatment groups

Experimental Treatment

Group I: MEK162 in Combination With Imatinib MesylateExperimental Treatment4 Interventions

Pts will be treated with the combination therapy of MEK162 \& imatinib. The phase Ib portion of the study, pts will receive imatinib at 400 mg once daily \& MEK162 at the standard 3+3 escalation doses. Phase Ib expansion cohort, pts will receive the RP2D: imatinib 400 mg once daily (standard of care first line imatinib dose) \& MEK162 at the RP2D twice daily. The phase II portion of the study, pts will receive imatinib at 400 mg once daily \& MEK162 at the RP2D. The MEK162 RP2D was originally determined based on the phase Ib escalation data \& it was established as 45 mg BID. After the completion of the phase Ib dose expansion \& initiation of phase II, the MEK162 RP2D was reduced to 30 mg BID30 for better long term tolerability. Patient's will now begin MEK162 at the revised RP2D of 30 mg BID. 1 cycle is 28 days. If no progression of the tumor is seen, pts will continue on therapy. Pts who have progression of disease will proceed directly to second line therapy as per standard of care.

Imatinib Mesylate is already approved in United States, European Union, Canada, Japan, China, Switzerland for the following indications:

🇺🇸 Approved in United States as Gleevec for: