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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.
Must not have
Patients have a severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection).
Patients have a history or current evidence of Central Serous Retinopathy (CSR) or retinal vein occlusion (RVO) or predisposing factors to CSR or RVO (i.e. uncontrolled glaucoma or ocular hypertension, uncontrolled diabetes mellitus, hyperviscosity or hypercoagulability syndromes).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
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.
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.
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 belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a severe illness like uncontrolled diabetes, kidney disease, or an active infection.
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I have or am at risk for eye conditions like CSR or RVO due to factors like uncontrolled diabetes or glaucoma.
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I have a long-term liver condition, such as cirrhosis.
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I have a history of eye diseases that cause vision loss.
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I have been diagnosed with Gilbert's syndrome.
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I am not pregnant or breastfeeding.
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I have had serious heart issues or procedures in the last 6 months.
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My high blood pressure is not controlled despite taking medication.
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I have a muscle disorder that causes high levels of an enzyme in my blood.
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I had major surgery less than 3 weeks ago or am still recovering from it.
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I have been treated with a MEK inhibitor before.
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I have brain metastasis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Best Response Rate (phase II portion)
maximum tolerated dose (MTD) (phase 1b portion)
Secondary study objectives
Progression Free Survival (PFS)
RR by CHOI criteria (phase II portion)
RR by EORTC criteria
+1 moreSide effects data
From 2019 Phase 3 trial • 402 Patients • NCT0176316444%
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%
RETINAL DETACHMENT
13%
PYREXIA
13%
EJECTION FRACTION DECREASED
13%
DECREASED APPETITE
13%
HYPERTENSION
10%
EYELID OEDEMA
10%
MYALGIA
10%
DYSPNOEA
10%
PRURITUS
10%
SKIN FISSURES
9%
ABDOMINAL PAIN
9%
ALANINE AMINOTRANSFERASE INCREASED
9%
ALOPECIA
9%
RASH MACULO-PAPULAR
8%
DRY MOUTH
8%
DYSGEUSIA
7%
HEADACHE
7%
ANAEMIA
7%
VISION BLURRED
7%
SUBRETINAL FLUID
7%
INTRAOCULAR PRESSURE INCREASED
7%
BACK PAIN
7%
ARTHRALGIA
7%
COUGH
7%
RASH PUSTULAR
6%
MACULAR OEDEMA
6%
ABDOMINAL PAIN UPPER
6%
PERIPHERAL SWELLING
6%
NECK PAIN
6%
MUSCULAR WEAKNESS
6%
DIZZINESS
6%
INSOMNIA
6%
ERYTHEMA
6%
NASOPHARYNGITIS
6%
ERYSIPELAS
5%
PERIORBITAL OEDEMA
5%
FACE OEDEMA
5%
WEIGHT DECREASED
4%
GENERAL PHYSICAL HEALTH DETERIORATION
4%
PAIN IN EXTREMITY
3%
LYMPHOPENIA
3%
GAMMA-GLUTAMYLTRANSFERASE INCREASED
1%
CELLULITIS
1%
PNEUMONITIS
1%
SKIN INFECTION
1%
RENAL FAILURE
1%
PULMONARY EMBOLISM
1%
HYPERTENSIVE CRISIS
1%
RETINAL VEIN THROMBOSIS
1%
PYELONEPHRITIS ACUTE
1%
SEPSIS
1%
SOFT TISSUE INFECTION
1%
UROSEPSIS
1%
INTERVERTEBRAL DISC PROTRUSION
1%
SPINAL CORD COMPRESSION
1%
HAEMORRHAGE
1%
CONFUSIONAL STATE
1%
NEUTROPENIA
1%
THROMBOCYTOPENIA
1%
PLATELET COUNT DECREASED
1%
RETINAL VEIN OCCLUSION
100%
80%
60%
40%
20%
0%
Study treatment Arm
Binimetinib (MEK162)
Dacarbazine
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
~1770
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,964 Previous Clinical Trials
596,862 Total Patients Enrolled
Ping Chi, MD, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
2 Previous Clinical Trials
28 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.My stomach and bowel functions are under control, despite having a condition.I had major surgery less than 3 weeks ago or am still recovering from it.I am a man who will use a condom during and 15 days after treatment to prevent drug exposure.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.I am 18 years old or older.I have another cancer, but it's not expected to affect my treatment.I have a severe illness like uncontrolled diabetes, kidney disease, or an active infection.I have or am at risk for eye conditions like CSR or RVO due to factors like uncontrolled diabetes or glaucoma.I have a long-term liver condition, such as cirrhosis.I have a history of eye diseases that cause vision loss.I have been diagnosed with Gilbert's syndrome.I am not pregnant or breastfeeding.I am fully active or restricted in physically strenuous activity but can do light work.My kidney, liver, and blood tests are within normal ranges.I am not pregnant and agree to use birth control during and for 3 months after the study.My heart is strong enough for the trial (LVEF ≥50% and QTc ≤480 ms).I can take pills by mouth.I have been treated with a MEK inhibitor before.I have brain metastasis.I have GIST and haven't had systemic therapy except for imatinib recently.
Research Study Groups:
This trial has the following groups:- Group 1: MEK162 in Combination With Imatinib Mesylate
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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