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RAF/MEK Inhibitor
Expansion for Colorectal Cancer
Phase 2
Waitlist Available
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year.
Awards & highlights
Study Summary
"This trial is testing whether a combination of three drugs can help to control advanced colorectal cancer that cannot be surgically removed and has not responded to standard treatment."
Who is the study for?
This trial is for patients with advanced colorectal cancer that can't be surgically removed and hasn't responded to anti-EGFR therapy. Participants should meet specific health criteria not detailed here.Check my eligibility
What is being tested?
The study tests avutometinib combined with defactinib and cetuximab to see if they can manage advanced colorectal cancer that's resistant to previous treatments.See study design
What are the potential side effects?
Potential side effects may include skin reactions, fatigue, nausea, diarrhea, liver enzyme changes, and increased risk of infections. Each patient's experience may vary.
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
Safety and adverse events (AEs)
Trial Design
2Treatment groups
Experimental Treatment
Group I: Safety Run InExperimental Treatment3 Interventions
If you are enrolled in the Safety Run In group, the dose of avutometinib you receive will depend on when you join this study. Up to 3 dose levels of avutometinib will be tested, and between 3-6 participants will be enrolled at each dose level.
The first group of participants will receive the planned starting dose level of avutometinib. Then, if no intolerable side effects are seen, a second group of participants will be enrolled to receive a higher dose. If intolerable side effects are seen, the second group will receive a lower dose. One of these 3 doses will be selected as the recommended dose of avutometinib in combination with cetuximab and defactinib.
Group II: ExpansionExperimental Treatment3 Interventions
If you are enrolled in the Expansion, you will receive avutometinib at the recommended dose that was found in Safety Run In.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Defactinib
2013
Completed Phase 1
~60
Cetuximab
2011
Completed Phase 3
~2480
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,975 Previous Clinical Trials
1,789,486 Total Patients Enrolled
Christine Parseghian, MDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
27 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the enrollment for this medical study currently accepting new participants?
"According to data from clinicaltrials.gov, this particular trial is not actively seeking new participants. Originally posted on October 31st, 2024 and last updated on April 12th, 2024, it has concluded patient recruitment. However, there are presently 963 other ongoing trials available for enrollment."
Answered by AI
Has Expansion been granted approval by the FDA?
"Based on our assessment at Power, we have assigned a safety rating of 2 to Expansion in this Phase 2 trial. This reflects existing data supporting safety without evidence yet available for efficacy."
Answered by AI
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