Palbociclib + Cetuximab for Colon Cancer

Overseen by Hanna K. Sanoff

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: UNC Lineberger Comprehensive Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial is testing a combination of two drugs, cetuximab and palbociclib, to treat patients with advanced colon cancer. The drugs work together to block cancer cell growth and division. The study focuses on patients whose cancer has specific protein characteristics and who have either not been treated with similar drugs before or have developed resistance after initial treatment.

Research Team

Hanna K. Sanoff

Principal Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

Adults with metastatic colorectal cancer who've had at least two prior chemotherapy regimens can join this trial. They must not be pregnant, able to swallow pills, and have no major surgeries in the last 4 weeks. Participants need normal organ function tests and cannot have active infections or CNS metastases. Prior CDK inhibitor treatment is a disqualifier.

Inclusion Criteria

I can take care of myself and am up and about more than half of my waking hours.

I haven't had any major surgeries in the last 4 weeks and all my surgical wounds have healed.

I am not pregnant and can prove it with a test taken in the last 72 hours.

Exclusion Criteria

I am currently being treated for an infection.

I have been treated with a drug targeting CDK before.

I am not taking any medications that can cause long QT syndrome, except for low-dose Ondansetron.

Treatment Details

Interventions

• Cetuximab (Monoclonal Antibodies)
• Palbociclib (CDK4/6 Inhibitor)

Trial Overview The study is testing the combination of Palbociclib (a drug that inhibits certain proteins) and Cetuximab (an antibody that targets cancer cells) in patients with advanced colon cancer to see if it's effective.

Participant Groups

Group I: Open-label, single arm, Phase II Experimental Treatment 2 Interventions

Cetuximab and palbociclib

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials

377

Recruited

95,900+

Dr. Shelley Earp

UNC Lineberger Comprehensive Cancer Center

Chief Medical Officer since 2018

MD from Johns Hopkins Medical School

Dr. Robert L. Ferris

UNC Lineberger Comprehensive Cancer Center

Chief Executive Officer

PhD in Immunology and MD from Johns Hopkins Medical School; Bachelor's in Chemistry from UNC-Chapel Hill

Amgen

Industry Sponsor

Trials

1,508

Recruited

1,433,000+

Founded

1980

Headquarters

Thousand Oaks, USA

Known For

Human Therapeutics

Top Products

Enbrel, Prolia, Neulasta, Otezla

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London

Pfizer

Industry Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University