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MEK Inhibitor
MEK162 + mFOLFIRI for Colorectal Cancer
Phase 1
Waitlist Available
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG Performance Status 0-1
Patients with histologically confirmed RAS (HRAS, NRAS, or KRAS) positive metastatic colorectal cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up patient safety will be evaluated throughout the treatment period (treatment with mek162 and mfolfiri which is expected to last 6-10 months for each patient)
Awards & highlights
Study Summary
This trial is testing a new cancer drug to see what dose is tolerated by patients and how well it works with another cancer drug. They will also be looking at safety parameters.
Who is the study for?
Adults over 18 with advanced RAS-positive metastatic colorectal cancer, who have progressed after first-line chemotherapy or can't take oxaliplatin. Participants must be in good physical condition (ECOG 0-1), able to consent, and have adequate organ function and cardiac health. They should not be pregnant/nursing, must agree to use contraception, and cannot join if they've had certain other cancers within 3 years or specific medical conditions that could affect safety or compliance.Check my eligibility
What is being tested?
The trial is testing the combination of a drug called MEK162 with mFOLFIRI chemotherapy to find the highest dose patients can tolerate without severe side effects (MTD). It's an early-phase study (Phase 1b) where everyone gets both treatments. The goal is also to see how well this combo works against colorectal cancer by measuring response rates.See study design
What are the potential side effects?
Potential side effects include typical reactions from chemotherapy like nausea, fatigue, hair loss, and blood cell count changes. MEK162 may cause skin rash, vision changes due to retinal vein occlusion risks, increased muscle enzymes indicating muscle damage, heart issues such as chest pain or heart attack risk increase especially for those with past heart problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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My colorectal cancer is RAS positive.
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My cancer got worse after or during my first treatment with specific chemotherapy, or I can't take a certain chemo drug due to side effects.
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I am older than 18 years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ patient safety will be evaluated throughout the treatment period (treatment with mek162 and mfolfiri which is expected to last 6-10 months for each patient)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~patient safety will be evaluated throughout the treatment period (treatment with mek162 and mfolfiri which is expected to last 6-10 months for each patient)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of dose limiting toxicities (DLTs) of combination MEK162 and mFOLFIRI
Trial Design
1Treatment groups
Experimental Treatment
Group I: MEK162 and mFOLFIRI, all patientsExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MEK162 and mFOLFIRI
2016
Completed Phase 1
~30
Find a Location
Who is running the clinical trial?
University of UtahLead Sponsor
1,099 Previous Clinical Trials
1,778,697 Total Patients Enrolled
PfizerIndustry Sponsor
4,568 Previous Clinical Trials
10,911,861 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have two copies of the UGT1A1 *28 gene variant.I haven't had cancer treatment or experimental therapy in the last 4 to 6 weeks.I had radiotherapy less than 2 weeks ago, except for treatment on bone metastasis.I had skin cancer or early-stage cervical cancer but am now treated.I have not had a heart attack or other major heart issues in the last 6 months.I have heart issues but not recent serious arrhythmias except for atrial fibrillation or supraventricular tachycardia.I do not have severe stomach or bowel problems that could affect drug absorption.I am fully active or can carry out light work.My blood tests and organ functions are within normal ranges.My heart is healthy according to the study's standards.I have recovered from side effects of previous cancer treatments, except for hair loss or mild nerve damage.I am willing and able to follow the study's requirements and can take pills.My cancer did not respond to previous irinotecan treatment, but I can handle its standard doses.I do not have a history of eye blood vessel blockage or conditions that could cause it.I have prostate cancer treated with surgery or hormone therapy, without signs of it getting worse.I had major surgery less than 3 weeks ago or am still dealing with its side effects.I will not start a new hard exercise plan after beginning the study treatment.I am a man who will use a condom during sex while on the study drug and for 90 days after, and I won't father a child or donate sperm during this time.I am able to understand and follow the study's requirements.My colorectal cancer is RAS positive.My cancer got worse after or during my first treatment with specific chemotherapy, or I can't take a certain chemo drug due to side effects.I am older than 18 years.I had a positive pregnancy test due to cancer, confirmed by an ultrasound before starting MEK162.I have been cancer-free for 3 years from another cancer, except for certain types.Additional reasons to include more participants in the study.My blood pressure is high (>150/100 mmHg) despite taking medication.I have a muscle disorder that causes high CK levels.I am using effective birth control if I can become pregnant.I do not have serious heart problems.You have a condition called Gilbert's syndrome in your medical history.I have been treated with a MEK inhibitor before.
Research Study Groups:
This trial has the following groups:- Group 1: MEK162 and mFOLFIRI, all patients
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What clinical indications are MEK162 and mFOLFIRI typically prescribed for?
"MEK162 and mFOLFIRI can be effective treatments for those with a BRAF V600K mutation, metastatic melanoma, or an unresectable form of the disease."
Answered by AI
Have the drugs MEK162 and mFOLFIRI been given regulatory approval by the US Food & Drug Administration?
"MEK162 and mFOLFIRI have minimal empirical evidence to support their safety, so they were given a score of 1."
Answered by AI
How many participants have been enlisted for this clinical experiment?
"Affirmative, according to the information on clinicaltrials.gov this medical trial is actively enrolling participants. The study was initially posted in August of 2016 and most recently modified in April 2022; they are currently looking for 30 patients at one location."
Answered by AI
Are there any prior experiments exploring the effects of MEK162 and mFOLFIRI?
"Currently, 59 investigations are underway to better understand the effects of MEK162 and mFOLFIRI. 3 of these studies fall under Phase 3, with 3073 sites across Melbourne, Victoria running trials on this medication."
Answered by AI
Is this research currently seeking participants?
"According to the clinicaltrials.gov listing, this research endeavour is actively looking for participants. It was initiated on August 19th 2016 and modified most recently on April 21st 2022."
Answered by AI
Is this experiment the inaugural one of its type?
"Since 2011, MEK162 and mFOLFIRI have been subject to clinical research. The initial study was conducted by Pfizer in 2011 with 183 participants; the drug received its Phase 2 approval following that trial. Nowadays, there are 59 independent studies running around the world in 1120 cities across 39 different nations."
Answered by AI
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