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

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 abemacicl

Trial Details

NCT ID

NCT06654037

Phase

PHASE1

Sponsor

National Cancer Institute (NCI)

Status

RECRUITING

Cancer Type

Colorectal Cancer

Interventions

Abemaciclib
Biopsy Procedure
Biospecimen Collection
Fluorouracil
Radiologic Imaging Procedure

Locations (sample)

Irvine, California, United States|33.66946,-117.82311
Orange, California, United States|33.78779,-117.85311
The Bronx, New York, United States|40.84985,-73.86641
The Bronx, New York, United States|40.84985,-73.86641
The Bronx, New York, United States|40.84985,-73.86641

Key Eligibility Criteria

Patients must have histologically or cytologically confirmed microsatellite stability (MSS) metastatic colorectal cancer where patients have progre…
Patients must have measurable disease
Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of abemaciclib in combination with 5-FU in patients \< 1…
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)

For full eligibility, visit ClinicalTrials.gov.

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