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Study identifier: NCT06654037 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Metastatic Microsatellite Stable Colorectal Carcinoma · Refractory Microsatellite Stable Colorectal Carcinoma · Stage IV Colorectal Cancer AJCC v8  ·  Sponsor: National Cancer Institute (NCI)

PhasePhase 1
Planned participants39
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Contact details are listed per location below or on the registry record.

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Locations (8)

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory CareIrvine, California, United StatesRecruiting
UC Irvine Health/Chao Family Comprehensive Cancer CenterOrange, California, United StatesRecruiting
Montefiore Medical Center-Einstein CampusThe Bronx, New York, United StatesRecruiting
Montefiore Medical Center-Weiler HospitalThe Bronx, New York, United StatesRecruiting
Montefiore Medical Center - Moses CampusThe Bronx, New York, United StatesRecruiting
University of Cincinnati Cancer Center-UC Medical CenterCincinnati, Ohio, United StatesRecruiting
University of Cincinnati Cancer Center-West ChesterWest Chester, Ohio, United StatesRecruiting
University of Pittsburgh Cancer Institute (UPCI)Pittsburgh, Pennsylvania, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT06654037