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
05/31/2022
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