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Tyrosine Kinase Inhibitor

MEK162 + Imatinib for Gastrointestinal Stromal Tumor

Phase 1 & 2

Waitlist Available

Led By Ping Chi, MD, PhD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have pathologically confirmed GIST.

In the Phase Ib portion, patients must have locally advanced or metastatic GIST and have progressed on imatinib.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is testing the effects of two drugs, MEK162 and imatinib, on Gastrointestinal Stromal Tumor (GIST). The funding for this trial comes from the FDA Office of Orphan Products Development and Array/Pfizer.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Possible side effects include typical reactions from cancer medications such as fatigue, nausea, skin rash, vision changes due to potential eye-related risks associated with MEK162. There may also be liver function changes and muscle pain related to elevated creatinine phosphokinase levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My diagnosis is a gastrointestinal stromal tumor (GIST).

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My GIST has worsened despite taking imatinib.

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I am 18 years old or older.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My kidney, liver, and blood tests are within normal ranges.

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My heart is strong enough for the trial (LVEF ≥50% and QTc ≤480 ms).

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I can take pills by mouth.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Best Response Rate (phase II portion)

maximum tolerated dose (MTD) (phase 1b portion)

Secondary outcome measures

Progression Free Survival (PFS)

RR by CHOI criteria (phase II portion)

RR by EORTC criteria

+1 more

Side effects data

From 2019 Phase 3 trial • 402 Patients • NCT01763164

44%

BLOOD CREATINE PHOSPHOKINASE INCREASED

41%

DIARRHOEA

39%

DERMATITIS ACNEIFORM

36%

OEDEMA PERIPHERAL

36%

RASH

32%

NAUSEA

25%

FATIGUE

22%

VOMITING

16%

ASTHENIA

14%

CONSTIPATION

14%

ASPARTATE AMINOTRANSFERASE INCREASED

14%

DRY SKIN

13%

PYREXIA

13%

RETINAL DETACHMENT

13%

EJECTION FRACTION DECREASED

13%

DECREASED APPETITE

13%

HYPERTENSION

10%

EYELID OEDEMA

10%

SKIN FISSURES

10%

MYALGIA

10%

DYSPNOEA

10%

PRURITUS

ABDOMINAL PAIN

ALANINE AMINOTRANSFERASE INCREASED

ALOPECIA

RASH MACULO-PAPULAR

DRY MOUTH

DYSGEUSIA

ANAEMIA

SUBRETINAL FLUID

BACK PAIN

ARTHRALGIA

HEADACHE

RASH PUSTULAR

VISION BLURRED

INTRAOCULAR PRESSURE INCREASED

COUGH

ABDOMINAL PAIN UPPER

PERIPHERAL SWELLING

MACULAR OEDEMA

NECK PAIN

DIZZINESS

MUSCULAR WEAKNESS

ERYTHEMA

NASOPHARYNGITIS

INSOMNIA

ERYSIPELAS

PERIORBITAL OEDEMA

FACE OEDEMA

WEIGHT DECREASED

PAIN IN EXTREMITY

GENERAL PHYSICAL HEALTH DETERIORATION

LYMPHOPENIA

GAMMA-GLUTAMYLTRANSFERASE INCREASED

SKIN INFECTION

PULMONARY EMBOLISM

RENAL FAILURE

HYPERTENSIVE CRISIS

RETINAL VEIN THROMBOSIS

SPINAL CORD COMPRESSION

CELLULITIS

SEPSIS

INTERVERTEBRAL DISC PROTRUSION

NEUTROPENIA

THROMBOCYTOPENIA

HAEMORRHAGE

CONFUSIONAL STATE

PNEUMONITIS

PYELONEPHRITIS ACUTE

SOFT TISSUE INFECTION

UROSEPSIS

PLATELET COUNT DECREASED

RETINAL VEIN OCCLUSION

100%

80%

60%

40%

20%

Study treatment Arm

Binimetinib (MEK162)

Dacarbazine

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

biopsy

2002

Completed Phase 4

~8270

MEK162

2013

Completed Phase 3

~1520