Spots Global Cancer Trial Database for Gemcitabine and Cisplatin With or Without CPI-613 as First Line Therapy for Patients With Advanced Unresectable Biliary Tract Cancer (BilT-04)
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Trial Identification
Brief Title: Gemcitabine and Cisplatin With or Without CPI-613 as First Line Therapy for Patients With Advanced Unresectable Biliary Tract Cancer (BilT-04)
Official Title: A Multi-Center Randomized Phase IB/II Study of Gemcitabine and Cisplatin With or Without CPI-613 as First Line Therapy for Patients With Advanced Unresectable Biliary Tract Cancer (BilT-04)
Study ID: NCT04203160
Conditions
Study Description
Brief Summary: 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Contact Details
Name: Vaibhav Sahai, MBBS, MS
Affiliation: University of Michigan Rogel Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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