Gemcitabine and Cisplatin With or Without CPI-613 (Devimistat)as First Line Therapy for Patients With Advanced Unresectable Biliary Tract Cancer (BilT-04)

Study Name
	Gemcitabine and Cisplatin With or Without CPI-613 (Devimistat)as First Line Therapy for Patients With Advanced Unresectable Biliary Tract Cancer (BilT-04)
ClinicalTrials.gov Identifier (if applicable)
	NCT04203160
Clinical Trial Category (check all that apply)
	First Line Therapy
Study Center
Institution Name
	University of Michigan Rogel Cancer Center
Institution Address
	1500 E Medical Center Dr.
City
	Ann Arbor
State
	Michigan
Zip Code
	48109
Country
	United States
Phone
	(800) 865-1125
Website
	https://clinicaltrials.gov/ct2/show/NCT04203160
List additional Institutions (include address, phone number, and website)
	University of Texas Southwestern University of Washington
Study Contacts
Principal Investigator
	Vaibhav Sahai, MBBS, MS
P.I. Phone
	(800) 865-1125
P.I. Email
	CancerAnswerLine@med.umich.edu
List additional Principal Investigators (include phone number and email)
	Muhammad Shalaan Beg, MD at UT Southwestern David Zhen, MD at University of Washington
Study Coordinator
	Meghan Johnson
Study Coordinator Phone
	(800) 865-1125
Study Coordinator Email
	CancerAnswerLine@med.umich.edu
OVERVIEW – in layman’s terms (150 words max)
	Patients with advanced biliary cancer (gallbladder or cholangiocarcinoma) previously untreated with systemic chemotherapy will receive gemcitabine + cisplatin + CPI-613 (targets enzymes that are involved in cancer cell energy metabolism).
Enrollment
	78
Study Start Date
	06/01/2020
Estimated Completion Date
	6/30/2025
Purpose of the Study – in Layman’s Terms (use the “+” to add more list items)
	Improve survival of patients with advanced biliary cancer Identify safe dose of CPI-613 (devimistat) when given in combination with gemcitabine and cisplatin
Inclusion Criteria – Patients Must:
	Tissue diagnosis of advanced, surgically inoperable biliary cancer No prior systemic chemotherapy for advanced cancer May have previously undergone radiation, liver directed therapy or surgery Must have measurable disease on CT or MR scans Age >= 18 years Performance status ECOG 0 or 1 Must be able to tolerate CT or MRI scans Adequate organ function (per protocol)
Exclusion Criteria – Patients Must NOT:
	No brain metastasis unless treated and stable for 3 months Underwent a major surgical procedure < 4 weeks prior to enrollment No prior organ transplantation No ongoing or uncontrolled infection Must not be pregnant or breast feeding No other active cancer (with some exceptions such as localized skin cancer) No active heart disease including symptomatic heart failure (NYHA class 3 or 4), unstable angina pectoris, uncontrolled cardiac arrhythmia or interstitial lung disease No prisoners or subjects who are involuntarily incarcerated, or compulsorily detained Prolonged QTcF interval >480 msec on ECG Psychiatric illness, other significant medical illness, or social situation which may limit compliance
REQUIRED TESTS PRIOR TO BEGINNING STUDY TREATMENT – in layman’s terms
	Blood tests, CT or MR scans
POTENTIAL SIDE-EFFECTS – in layman’s terms
	Tiredness (fatigue) Low blood counts (e.g. anemia) Nausea (usually mild to moderate) from cisplatin and/or gemcitabine Potential for kidney damage from cisplatin and/or gemcitabine Potential for hearing loss / ringing in ears from cisplatin Low appetite from gemcitabine and/or cisplatin