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

Part of paid clinical trials in Irvine, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT06654037
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Metastatic Microsatellite Stable Colorectal Carcinoma
  • Refractory Microsatellite Stable Colorectal Carcinoma
  • Stage IV Colorectal Cancer AJCC v8

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Abemaciclib — DRUG
    Given PO
  • Biopsy Procedure — PROCEDURE
    Undergo tissue biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Fluorouracil — DRUG
    Given IV
  • Radiologic Imaging Procedure — PROCEDURE
    Undergo radiologic imaging

Study Details

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.

Key Dates

Start date
Apr 18, 2025
Status verified
Apr 2026
Primary completion
Apr 1, 2027
Completion
Apr 1, 2027

Study Design

Enrollment
39 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (abemaciclib, 5-FU)
    Patients receive abemaciclib PO BID on days 1-28 and 5-FU IV over 46 hours on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection and radiologic imaging throughout the study and may additionally undergo a tissue biopsy before treatment and on cycle 1 day 16.

Primary Outcome Measure

Dose-limiting toxicity (DLT) [ Time Frame: Within first cycle (cycle length = 28 days) ]

Locations (8)

FacilityCityStateZIPSite coordinators
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory CareIrvineCalifornia92612
Site Public Contact
[email protected]
877-827-8839
Farshid Dayyani (PRINCIPAL_INVESTIGATOR)
UC Irvine Health/Chao Family Comprehensive Cancer CenterOrangeCalifornia92868
Site Public Contact
[email protected]
877-827-8839
Farshid Dayyani (PRINCIPAL_INVESTIGATOR)
Montefiore Medical Center - Moses CampusThe BronxNew York10467
Site Public Contact
[email protected]
718-379-6866
Chaoyuan Kuang (PRINCIPAL_INVESTIGATOR)
Montefiore Medical Center-Einstein CampusThe BronxNew York10461
Site Public Contact
[email protected]
718-379-6866
Chaoyuan Kuang (PRINCIPAL_INVESTIGATOR)
Montefiore Medical Center-Weiler HospitalThe BronxNew York10461
Site Public Contact
[email protected]
718-379-6866
Chaoyuan Kuang (PRINCIPAL_INVESTIGATOR)
University of Cincinnati Cancer Center-UC Medical CenterCincinnatiOhio45219
Site Public Contact
[email protected]
513-584-7698
Davendra P. Sohal (PRINCIPAL_INVESTIGATOR)
University of Cincinnati Cancer Center-West ChesterWest ChesterOhio45069
Site Public Contact
[email protected]
513-584-7698
Davendra P. Sohal (PRINCIPAL_INVESTIGATOR)
University of Pittsburgh Cancer Institute (UPCI)PittsburghPennsylvania15232
Site Public Contact
412-647-8073
Janie Y. Zhang (PRINCIPAL_INVESTIGATOR)

Find similar trials in Irvine, CA

By research site
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care· Irvine, CAUC Irvine Health/Chao Family Comprehensive Cancer Center· Orange, CAMontefiore Medical Center - Moses Campus· The Bronx, NYMontefiore Medical Center-Einstein Campus· The Bronx, NYMontefiore Medical Center-Weiler Hospital· The Bronx, NYUniversity of Cincinnati Cancer Center-UC Medical Center· Cincinnati, OH

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