RecruitingPhase 1NCT06654037

Testing the Addition of an Anti-Cancer Drug, Abemaciclib, to the Usual Chemotherapy Treatment (5-Fluorouracil) for Metastatic, Refractory Colorectal Cancer

A Phase 1 Study of 5-Fluorouracil in Combination With Abemaciclib in Metastatic, Refractory CRC


Sponsor

National Cancer Institute (NCI)

Enrollment

39 participants

Start Date

Apr 18, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This phase I trial tests the safety, side effects, and best dose of abemaciclib in combination with 5-fluorouracil and how well it works in treating patients with colorectal cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and that has not responded to treatment (refractory). Abemaciclib, a type of cyclin-dependent kinase inhibitor, blocks certain proteins, which may help keep tumor cells from growing. 5-fluorouracil, a type of antimetabolite, stops cells from making deoxyribonucleic acid (DNA) and may kill tumor cells. Giving abemaciclib in combination with 5-fluorouracil may be safe, tolerable, and/or effective in treating patients with metastatic and refractory colorectal cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding abemaciclib — a drug that blocks cancer cell growth — to standard chemotherapy (5-fluorouracil, or 5-FU) can help patients with metastatic colorectal cancer that has stopped responding to multiple prior treatments. **You may be eligible if...** - You are 18 or older with confirmed microsatellite stable (MSS) metastatic colorectal cancer - Your cancer has already progressed on standard chemotherapy combinations including 5-FU, oxaliplatin, and irinotecan - You have also progressed on or been intolerant to bevacizumab - If your tumor is left-sided and RAS wild-type, you must also have received anti-EGFR antibody therapy - You have measurable disease and are in adequate overall health **You may NOT be eligible if...** - You have not yet tried standard chemotherapy combinations - Your cancer has a microsatellite instability-high (MSI-H) profile - You are under 18 - Your organ function is too poor Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAbemaciclib

Given PO

PROCEDUREBiopsy Procedure

Undergo tissue biopsy

PROCEDUREBiospecimen Collection

Undergo blood sample collection

DRUGFluorouracil

Given IV

PROCEDURERadiologic Imaging Procedure

Undergo radiologic imaging


Locations(8)

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Irvine, California, United States

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, United States

Montefiore Medical Center-Einstein Campus

The Bronx, New York, United States

Montefiore Medical Center-Weiler Hospital

The Bronx, New York, United States

Montefiore Medical Center - Moses Campus

The Bronx, New York, United States

University of Cincinnati Cancer Center-UC Medical Center

Cincinnati, Ohio, United States

University of Cincinnati Cancer Center-West Chester

West Chester, Ohio, United States

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, United States

View Full Details on ClinicalTrials.gov

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NCT06654037


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