Gemcitabine and Cisplatin With or Without CPI-613 as First Line Therapy for Patients With Advanced Unresectable Biliary Tract Cancer (BilT-04)
Stopped early · Phase 1/Phase 2
Conditions studied: Biliary Tract Cancer
In brief
The purpose of this research study is to determine the safety and efficacy of CPI-613 (devimistat) in the treatment of advanced biliary tract cancer when used in combination with standard of care chemotherapy (gemcitabine plus cisplatin) compared to gemcitabine plus cisplatin alone. This research study has two parts: In the phase 1 portion of this study, patients will receive a combination of CPI-613 and standard of care chemotherapy. Dose levels of CPI-613 will be adjusted to find the best dose, which will be the recommended phase 2 dose level. In the phase 2 portion of this study, patients will be randomized into two arms. Patients in Arm A will receive the combination of the recommended dose level of CPI-613 and standard of care chemotherapy. Patients in Arm B will receive standard of care chemotherapy. At the end of the study, researchers will compare the health outcomes of the patients that received CPI-613 + standard care to the outcomes of patients that received only standard care.
Key facts
- Study ID
- NCT04203160
- Run by
- University of Michigan Rogel Cancer Center
- People needed
- 75
- Starts
- 2020-06-23
- Expected to finish
- 2024-04-29
- Last updated by the study team
- 2025-12-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of Arizona Cancer Center — Tucson, Arizona, United States
- Northwestern University -- Lurie Comprehensive Cancer Center — Chicago, Illinois, United States
- University of Michigan Rogel Cancer Center — Ann Arbor, Michigan, United States
- Atlantic Health System — Morristown, New Jersey, United States
- University Hospitals - Seidman Cancer Center — Cleveland, Ohio, United States
- Allegheny Health Network — Pittsburgh, Pennsylvania, United States
- Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States
- University of Texas Southwestern -- Simmons Comprehensive Cancer Center — Dallas, Texas, United States
- Fred Hutch/University of Washington Cancer Consortium — Seattle, Washington, United States
- University of Wisconsin - Carbone Cancer Center — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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