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Monoclonal Antibodies
Ulixertinib + Cetuximab / Encorafenib for Colorectal Cancer
Phase 1
Recruiting
Led By Christine Parseghian, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18 years at the time of informed consent.
Histologically (or cytologically) confirmed diagnosis of adenocarcinoma of the colon or rectum, with clinical confirmation of unresectable and/or metastatic disease that is measurable according to RECIST1.1 criteria.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year
Awards & highlights
Study Summary
This trial aims to find the best dose of ulixertinib for patients with advanced colorectal cancer who have had EGFR or BRAF-directed therapy.
Who is the study for?
Adults over 18 with unresectable/metastatic colorectal cancer who've had prior EGFR or BRAF therapy can join. They must have adequate organ function, be able to take oral meds, and use effective contraception if of childbearing potential. Exclusions include previous ERK1/2 inhibitor exposure, certain infections like hepatitis B/C, heart conditions, uncontrolled hypertension, recent major surgery, pregnancy/nursing status.Check my eligibility
What is being tested?
The trial is testing the optimal dose of ulixertinib alone or combined with cetuximab and/or encorafenib in patients with advanced colorectal cancer previously treated with EGFR/BRAF therapies. It's an open-label study where everyone knows what treatment they're getting.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to medication components (especially for those with red meat allergies), liver issues due to high bilirubin levels, cardiovascular problems such as arrhythmias or heart failure symptoms, and increased risk of infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
To provide a clear and concise summary, I would need more information about the specific prior treatments mentioned in the criterion. Could you please provide the complete criterion?
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion; an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort AExperimental Treatment2 Interventions
1 of these 2 doses will be selected as the recommended dose of ulixertinib that can be given in combination with cetuximab alone.
Group II: BRAF Expansion CohortExperimental Treatment3 Interventions
1 of these 2 doses will be selected as the recommended dose of ulixertinib that can be given in combination with cetuximab and encorafenib.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ulixertinib
2020
Completed Phase 1
~20
Encorafenib
2021
Completed Phase 3
~960
Cetuximab
2011
Completed Phase 3
~2480
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,319 Total Patients Enrolled
BioMed Valley Discoveries, IncIndustry Sponsor
16 Previous Clinical Trials
711 Total Patients Enrolled
Eli Lilly and CompanyIndustry Sponsor
2,620 Previous Clinical Trials
3,216,572 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of a condition called retinal vein occlusion or central serous retinopathy, or you are at risk of developing these conditions.You had a severe allergic reaction or couldn't tolerate cetuximab or panitumumab in the past.You have a heart condition or other serious cardiovascular problems.You have experienced a severe allergic reaction or could not tolerate encorafenib or other medications that target the BRAF gene.You have visible signs of cancer spread to your brain that are causing symptoms.You have a condition that affects your ability to digest and absorb medication, such as ulcerative diseases or problems with vomiting or nutrient absorption in the intestines.You have had allergic reactions to drugs that are similar to cetuximab, or you have a history of allergic reactions to red meat or tick bites.To provide a clear and concise summary, I would need more information about the specific prior treatments mentioned in the criterion. Could you please provide the complete criterion?You have a history of fainting due to heart problems, abnormal heart rhythm like ventricular tachycardia or ventricular fibrillation, or sudden cardiac arrest.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort A
- Group 2: BRAF Expansion Cohort
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 safety protocols are in place for participants of the BRAF Expansion Cohort?
"The BRAF Expansion Cohort received a score of 1 due to the limited amount of data that exists on its efficacy and safety profile."
Answered by AI
Are there still vacancies for prospective test subjects to join this clinical trial?
"The clinicaltrials.gov website indicates that this trial, which was first established on January 31st 2024 and updated lastly on August 9th 2023, is no longer actively recruiting participants. However, there are currently 937 other studies in the midst of recruitment processes."
Answered by AI
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