Drug Combination for Advanced 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

No Placebo-Only Group

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.

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.

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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety and adverse events (AEs)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Cetuximab

2011

Completed Phase 3

~2480

Defactinib

2013