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NCT06654037 · ClinicalTrials.gov registry record · Phase 1
Testing the Addition of an Anti-Cancer Drug, Abemaciclib, to the Usual Chemotherapy Treatment (5-Fluorouracil) for Metastatic, Refractory Colorectal Cancer
A Phase 1 study of Stage IV Colorectal Cancer AJCC v8 and Metastatic Microsatellite Stable Colorectal Carcinoma, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 39
- Enrollment target
- 8
- Study locations
NCT06654037 is a Phase 1 study of Stage IV Colorectal Cancer AJCC v8 and Metastatic Microsatellite Stable Colorectal Carcinoma that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 39 participants, below the 107-participant average among 22 other Stage IV Colorectal Cancer AJCC v8 trials with a reported enrollment target (64% lower). The trial reports 8 study locations across 4 states.
The verdict
NCT06654037, a Phase 1 study of Stage IV Colorectal Cancer AJCC v8 and Metastatic Microsatellite Stable Colorectal Carcinoma, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 39 participants
- Enrollment target
- 8
- Study locations
Study Summary
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 Studied
Interventions
- PROCEDURE Biospecimen Collection
- DRUG Fluorouracil
- PROCEDURE Biopsy Procedure
- DRUG Abemaciclib
- PROCEDURE Radiologic Imaging Procedure
Study Locations (8)
New York
- Montefiore Medical Center-Einstein Campus - The Bronx
- Montefiore Medical Center-Weiler Hospital - The Bronx
- Montefiore Medical Center - Moses Campus - The Bronx
California
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care - Irvine
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
Ohio
- University of Cincinnati Cancer Center-UC Medical Center - Cincinnati
- University of Cincinnati Cancer Center-West Chester - West Chester
Pennsylvania
- University of Pittsburgh Cancer Institute (UPCI) - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2025-04-18 |
| Est. Completion | 2026-04-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06654037
The ClinicalTrials.gov registry entry for NCT06654037 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 107-participant average among 22 other Stage IV Colorectal Cancer AJCC v8 trials with a reported enrollment target (64% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Stage IV Colorectal Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06654037 reports 8 study locations spanning 4 distinct geographic areas - top geographies include New York, California, Ohio.
Frequently Asked Questions
What is clinical trial NCT06654037 about?
NCT06654037 is a clinical study titled "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 re...
What is the current status of trial NCT06654037?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2025-04-18. Estimated completion is 2026-04-01.
What conditions does trial NCT06654037 study?
This clinical trial studies the following conditions: Stage IV Colorectal Cancer AJCC v8, Metastatic Microsatellite Stable Colorectal Carcinoma, Refractory Microsatellite Stable Colorectal Carcinoma.
What interventions are being tested in trial NCT06654037?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Fluorouracil (DRUG), Biopsy Procedure (PROCEDURE), Abemaciclib (DRUG), Radiologic Imaging Procedure (PROCEDURE).
Who is sponsoring clinical trial NCT06654037?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06654037 being conducted?
This trial has 8 study locations across California, New York, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Stage IV Colorectal Cancer AJCC v8
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Metastatic Microsatellite Stable Colorectal Carcinoma
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.