๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-07-30

Testing the Addition of an Anti-Cancer Drug, Abemaciclib, to the Usual Chemotherapy Treatment (5-Fluorouracil) for Metastatic, Refractory Colorectal Cancer (NCT06654037)

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

๐ŸŸข Recruiting Phase1 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: National Cancer Institute (NCI)

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care โ€” Irvine, California

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (8 Sites)

  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care โ€” Irvine, California
  • UC Irvine Health/Chao Family Comprehensive Cancer Center โ€” Orange, California
  • Montefiore Medical Center-Einstein Campus โ€” The Bronx, New York
  • Montefiore Medical Center-Weiler Hospital โ€” The Bronx, New York
  • Montefiore Medical Center - Moses Campus โ€” The Bronx, New York
  • University of Cincinnati Cancer Center-UC Medical Center โ€” Cincinnati, Ohio
  • University of Cincinnati Cancer Center-West Chester โ€” West Chester, Ohio
  • UPMC Hillman Cancer Center โ€” Pittsburgh, Pennsylvania

๐Ÿ“ž Contact the Study Coordinator

Phone: (877) 827-8839

Email: ucstudy@uci.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Metastatic Microsatellite Stable Colorectal Carcinoma

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—