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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: Recruiting Phase 1 study of Stage IV Colorectal Cancer AJCC v8 and Metastatic Microsatellite Stable Colorectal Carcinoma, sponsored by National Cancer Institute (NCI).
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Will be tabulated using Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0 for each dose level.
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 |
What NCT06654037 shows while recruiting
NCT06654037 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 107-participant average among 22 other Stage IV Colorectal Cancer AJCC v8 trials with a reported enrollment target (64% lower).
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 lists 8 locations in 4 states (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.
Learn More About Clinical Trials
Similar trials for Stage IV Colorectal Cancer AJCC v8
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06654037's enrollment target sits among peer trials
39 10th of 22 higher than 13 of 22 other Stage IV Colorectal Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage IV Colorectal Cancer AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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