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

NCT04203160

Institution Name

University of Michigan Rogel Cancer Center

Full Institution Address

1500 E Medical Center Dr. Ann Arbor Michigan 48109 United States

Institution Phone

(800) 865-1125

Institution Website

https://clinicaltrials.gov/ct2/show/NCT04203160

Additional Institutions

University of Texas Southwestern University of Washington

Principal Investigator

Vaibhav Sahai, MBBS, MS

Principal Investigator Phone

(800) 865-1125

Principal Investigator Email

[email protected]

Additional Principal Investigators

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

[email protected]

Study Overview

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 Information

78

Study Start Date

20200601

Study End Date

20250630

Study Purpose

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

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

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 Study

Blood tests, CT or MR scans

Potential Side Effects

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

Financial Assistance Available

No

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