Actively Recruiting
Testing the Addition of an Anti-Cancer Drug, Abemaciclib, to the Usual Chemotherapy Treatment (5-Fluorouracil) for Metastatic, Refractory Colorectal Cancer
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
39
Participants Needed
8
Research Sites
101 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Testing the Addition of an Anti-Cancer Drug, Abemaciclib, to the Usual Chemotherapy Treatment (5-Fluorouracil) for Metastatic, Refractory Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Histologically or cytologically confirmed microsatellite stable metastatic colorectal cancer with progression on standard therapies including 5-FU or capecitabine, oxaliplatin, and irinotecan
- Progression or intolerance to bevacizumab and anti-EGFR antibodies for left-sided, RAS-wildtype colorectal cancer
- Measurable disease
- ECOG performance status of 2 or less (Karnofsky 60% or higher)
- Hemoglobin 8 g/dL or higher
- Absolute neutrophil count 1,500/mcL or higher
- Platelet count 100,000/mcL or higher
- Total bilirubin less than or equal to 1.5 times institutional upper limit of normal
- AST/ALT less than or equal to 3 times upper limit for patients without liver metastases, or less than or equal to 5 times for those with liver metastases
- Glomerular filtration rate 50 mL/min/1.73 m2 or higher
- HIV-infected patients on effective antiretroviral therapy with undetectable viral load within 6 months
- Patients with controlled chronic hepatitis B or cured hepatitis C virus infection
- Patients with treated brain metastases showing no progression on follow-up imaging
- Patients with prior or concurrent malignancy not interfering with study assessments
- Cardiac function classified as New York Heart Association class II or better
- Availability of archival tumor tissue or willingness to undergo biopsy
- Completion of previous systemic therapy at least two weeks or five half-lives prior to study
- No major surgery within 14 days before randomization
- No serious or uncontrolled preexisting medical conditions that would interfere with study participation
- Recovery from any prior radiotherapy effects with at least 14 days washout
- Ability to swallow oral medications
- No personal history of certain serious cardiac arrhythmias or sudden cardiac arrest
- No active systemic bacterial or fungal infection requiring IV antibiotics
- Agreement to use adequate contraception during and for 3 months after study participation
- Ability to understand and sign informed consent
You will not qualify if you...
- Unresolved adverse events from prior anticancer therapy greater than grade 1, except alopecia or grade 2 peripheral neuropathy
- Current use of any other investigational agents without required washout
- History of allergic reactions or intolerance to abemaciclib, 5-FU, capecitabine, or related compounds
- Prior treatment with CDK4/6 inhibitors
- Gastrointestinal conditions affecting oral medication absorption
- Peritoneal metastases with ascites requiring frequent therapeutic paracentesis
- Use of strong CYP3A enzyme inhibitors or inducers before or during study
- Uncontrolled intercurrent illness or conditions posing unreasonable risk
- Pregnant or breastfeeding women due to potential risks from study drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, United States, 92612
Actively Recruiting
2
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Actively Recruiting
3
Montefiore Medical Center-Einstein Campus
The Bronx, New York, United States, 10461
Actively Recruiting
4
Montefiore Medical Center-Weiler Hospital
The Bronx, New York, United States, 10461
Actively Recruiting
5
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States, 10467
Actively Recruiting
6
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, United States, 45219
Actively Recruiting
7
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, United States, 45069
Actively Recruiting
8
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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