Testing the Addition of an Anti-Cancer Drug, Abemaciclib, to the Usual Chemotherapy Treatment (5-Fluorouracil) for Metastatic, Refractory Colorectal Cancer
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Rak jelita grubego, który się rozprzestrzenił i nie reaguje na standardowe leczenie (w tym 5-FU, kapecytabina, oksaliplatyna, irynotekan) lub jest na nie nietolerowany.
- •Pacjent ma widoczne zmiany nowotworowe w badaniach obrazowych.
- •Wiek powyżej 18 lat.
- •Ogólny stan zdrowia pozwalający na aktywność (skala ECOG ≤ 2 lub Karnofsky ≥ 60%).
- •Poziom hemoglobiny co najmniej 8 g/dL.
- •Odpowiednia liczba białych krwinek (neutrofili) – co najmniej 1500/mcL.
- •Odpowiednia liczba płytek krwi – co najmniej 100 000/mcL.
- •Wątrobowe enzymy (bilirubina, AST/ALT) w normie lub nieznacznie podwyższone w zależności od przerzutów do wątroby.
✗ Disqualifies
- •Pacjenci poniżej 18 roku życia.
- •Pacjenci, u których rak jelita grubego jest oporny na leczenie (nie ma odpowiedzi na dotychczasowe terapie).
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- July 31, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (8)
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, United States
Montefiore Medical Center-Einstein Campus
The Bronx, United States
Montefiore Medical Center-Weiler Hospital
The Bronx, United States
Montefiore Medical Center - Moses Campus
The Bronx, United States
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, United States
University of Cincinnati Cancer Center-West Chester
West Chester, United States
UPMC Hillman Cancer Center
Pittsburgh, United States
Trial contact
Site Public Contact
Farshid Dayyani
PRINCIPAL_INVESTIGATOR
Site Public Contact
Chaoyuan Kuang
PRINCIPAL_INVESTIGATOR
Site Public Contact
Davendra P. Sohal
PRINCIPAL_INVESTIGATOR
Site Public Contact
Janie Y. Zhang
PRINCIPAL_INVESTIGATOR
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/1/2026.
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