Clinical trialNCT06654037RecruitingPhase 1Interventional

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

SponsorNational Cancer Institute (NCI)Enrollment39Metastatic Microsatellite Stable Colorectal CarcinomaRefractory Microsatellite Stable Colorectal CarcinomaStage IV Colorectal Cancer AJCC v8

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Janie Y Zhang
UPMC Hillman Cancer Center LAO
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

8 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Uci Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, United States
Farshid Dayyani →
Recruiting
Uc Irvine Health/chao Family Comprehensive Cancer Center
Orange, California, United States
Farshid Dayyani →
Recruiting
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States
Chaoyuan Kuang
Recruiting
Montefiore Medical Center-Einstein Campus
The Bronx, New York, United States
Chaoyuan Kuang
Recruiting
Montefiore Medical Center-Weiler Hospital
The Bronx, New York, United States
Chaoyuan Kuang
Recruiting
University of Cincinnati Cancer Center-Uc Medical Center
Cincinnati, Ohio, United States
Davendra P. Sohal
Recruiting
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, United States
Davendra P. Sohal
Recruiting
Upmc Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Janie Y. Zhang
Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

AbemaciclibFluorouracil

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 18 Apr 2025
Primary completion: 1 Apr 2027
Completion: 1 Apr 2027
Last update posted: 31 Jul 2026
Registered enrollment: 39
Registry id: NCT06654037

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.