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Kinase Inhibitor
Binimetinib + Palbociclib/TAS-102 for Colorectal Cancer
Phase 2
Waitlist Available
Led By Scott Kopetz
Research Sponsored by Academic and Community Cancer Research United
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status (PS) of 0 or 1
Documented mutation in KRAS or NRAS (codon 12, 13, 59, 61, 117, or 146) in tumor tissue from primary or metastatic site, tested by a Clinical Laboratory Improvement Act (CLIA)-certified laboratory
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
Study Summary
This trial is studying how well binimetinib and palbociclib work compared to TAS-102 in treating patients with metastatic or unresectable colorectal cancer.
Who is the study for?
This trial is for adults with colorectal cancer that has spread and can't be surgically removed, who have specific KRAS or NRAS mutations. They must have normal organ function, no history of certain heart conditions or brain metastases, not be pregnant or breastfeeding, and willing to use contraception.Check my eligibility
What is being tested?
The effectiveness of binimetinib combined with palbociclib versus TAS-102 is being tested in patients with advanced colorectal cancer carrying KRAS/NRAS mutations. The study aims to see if these drugs can better inhibit tumor growth compared to the standard chemotherapy drug TAS-102.See study design
What are the potential side effects?
Potential side effects include fatigue, nausea, diarrhea, low blood cell counts leading to increased infection risk and bleeding problems. There may also be liver issues indicated by altered blood tests and possible heart complications.
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 cancer has a specific mutation in the KRAS or NRAS gene.
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My cancer has a specific mutation in the KRAS or NRAS gene.
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I have been treated with specific chemotherapy drugs and a therapy targeting blood vessel growth.
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My heart is healthy and I haven't had major heart issues in the last 6 months.
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I can swallow pills without any issues.
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My colorectal cancer has spread and cannot be removed by surgery.
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My high blood pressure is not controlled, even with medication.
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I am fully active or restricted in physically strenuous activity but can do light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression Free Survival (PFS)
Secondary outcome measures
Number of Participants With Adverse Events
Overall Response Rate
Overall Survival (OS)
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm B (trifluridine and tipiracil hydrochloride)Experimental Treatment1 Intervention
Patients receive trifluridine and tipiracil hydrochloride PO BID on days 1-5 and 8-12. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients with disease progression may optionally crossover to Arm A.
Group II: Arm A (binimetinib, palbociclib)Experimental Treatment2 Interventions
Patients receive binimetinib PO BID on days 1-28 and palbociclib PO QD on days 1-21. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Palbociclib
2017
Completed Phase 3
~3760
Trifluridine and Tipiracil Hydrochloride
2019
Completed Phase 2
~70
Binimetinib
2018
Completed Phase 3
~1100
Find a Location
Who is running the clinical trial?
Academic and Community Cancer Research UnitedLead Sponsor
53 Previous Clinical Trials
5,034 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,680 Previous Clinical Trials
40,928,417 Total Patients Enrolled
Scott KopetzPrincipal InvestigatorAcademic and Community Cancer Research United
1 Previous Clinical Trials
96 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or can carry out light work.I have a muscle disorder that causes high CPK levels.You have a condition that can be measured and tracked during the study.I have been treated with trifluridine/tipiracil before.You have a medical, mental health, or substance use condition that may affect your ability to understand information about the study, participate in the study, or complete the study.My cancer has a specific mutation in the KRAS or NRAS gene.My cancer has a specific mutation in the KRAS or NRAS gene.I have not had a stroke or significant blood clot in the last 3 months.Your bilirubin levels, which indicate liver function, should not exceed the normal range by more than 1.5 times.I do not have serious heart problems or uncontrolled high blood pressure.I had major surgery less than 3 weeks ago or am still dealing with its side effects.I haven't had cancer, except for certain skin cancers or cancers treated over 3 years ago, in the last 3 years.I haven't had cancer treatment or radiotherapy in the last 3 weeks and any side effects are mild.I have been treated with specific chemotherapy drugs and a therapy targeting blood vessel growth.I do not have a GI condition that affects medication absorption.I have or am at risk for blocked blood vessels in my eye due to conditions like uncontrolled glaucoma.My heart is healthy and I haven't had major heart issues in the last 6 months.You are allergic to the study drug or similar medication.Your platelet count needs to be at least 75 x 10^9/L without any recent blood transfusions (within the last 14 days, unless specified otherwise).My kidney function is normal, based on recent tests.Your blood test shows a healthy level of neutrophils (a type of white blood cell).I have not had pancreatitis in the last 6 months.I am a sexually active male and agree to use contraception during and for 12 weeks after the study.I have had treatment for inflammatory bowel disease or Crohn's within the last year.My cancer has spread to the lining of my brain and spinal cord.I haven't had a stroke or significant blood clot in the last 3 months.I don't have symptoms from brain metastasis without needing steroids or anti-seizure meds.My liver function tests are within the required range.I can swallow pills without any issues.My colorectal cancer has spread and cannot be removed by surgery.My kidney function is normal, based on recent tests.I do not have any severe illnesses that would stop me from following the study's requirements.Your hemoglobin levels must be at least 9 grams per deciliter. This will be checked within 14 days before you start the study.I am committed and able to follow the treatment and check-up schedule.My high blood pressure is not controlled, even with medication.I can become pregnant but agree to use effective birth control during and 8 weeks after the study.I am fully active or restricted in physically strenuous activity but can do light work.I have been treated with drugs targeting BRAF, MEK, ERK, or CDK, but regorafenib is okay.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (binimetinib, palbociclib)
- Group 2: Arm B (trifluridine and tipiracil hydrochloride)
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.
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