OncoMatch/Clinical Trials/NCT06654037
Testing the Addition of an Anti-Cancer Drug, Abemaciclib, to the Usual Chemotherapy Treatment (5-Fluorouracil) for Metastatic, Refractory Colorectal Cancer
Is NCT06654037 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Abemaciclib and Fluorouracil for metastatic microsatellite stable colorectal carcinoma.
Treatment: Abemaciclib · Fluorouracil — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: MMR microsatellite stable
microsatellite stability (MSS)
Required: KRAS wild-type
anti-EGFR antibodies (cetuximab or panitumumab) in patients who have left-sided and RAS-wildtype CRC
Required: NRAS wild-type
anti-EGFR antibodies (cetuximab or panitumumab) in patients who have left-sided and RAS-wildtype CRC
Required: HRAS wild-type
anti-EGFR antibodies (cetuximab or panitumumab) in patients who have left-sided and RAS-wildtype CRC
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: antimetabolite (5-fluorouracil, capecitabine)
progressed on standard therapies which would have included 5-FU or capecitabine
Must have received: platinum-based chemotherapy (oxaliplatin)
progressed on standard therapies which would have included...oxaliplatin
Must have received: topoisomerase inhibitor (irinotecan)
progressed on standard therapies which would have included...irinotecan
Must have received: VEGF inhibitor (bevacizumab)
progression of disease (PD) or intolerance to bevacizumab
Must have received: EGFR-targeted therapy (cetuximab, panitumumab)
progression of disease (PD) or intolerance to...anti-EGFR antibodies (cetuximab or panitumumab) in patients who have left-sided and RAS-wildtype CRC
Cannot have received: CDK4/6 inhibitor
Patients who have received previous treatment with a CDK4/6 inhibitor
Lab requirements
Blood counts
Hemoglobin ≥ 8 g/dL; Absolute neutrophil count ≥ 1,500/mcL; Platelets ≥ 100,000/mcL
Kidney function
Glomerular filtration rate (GFR) ≥ 50 mL/min/1.73 m^2
Liver function
Total bilirubin ≤ 1.5 x institutional ULN; AST/ALT ≤ 3 x institutional ULN for patients without liver metastases, and ≤ 5 x institutional ULN for patients with liver metastases
Cardiac function
NYHA class II or better; no personal history of syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin, or sudden cardiac arrest
Hemoglobin ≥ 8 g/dL; Absolute neutrophil count ≥ 1,500/mcL; Platelets ≥ 100,000/mcL; Total bilirubin ≤ 1.5 x institutional ULN; AST/ALT ≤ 3 x institutional ULN for patients without liver metastases, and ≤ 5 x institutional ULN for patients with liver metastases; Glomerular filtration rate (GFR) ≥ 50 mL/min/1.73 m^2; NYHA class II or better; no personal history of syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin, or sudden cardiac arrest
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care · Irvine, California
- UC Irvine Health/Chao Family Comprehensive Cancer Center · Orange, California
- Montefiore Medical Center-Einstein Campus · The Bronx, New York
- Montefiore Medical Center-Weiler Hospital · The Bronx, New York
- Montefiore Medical Center - Moses Campus · The Bronx, New York
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