ClinicalTrials.gov record
Terminated Phase 1Phase 2 Interventional Results available

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

ClinicalTrials.gov ID: NCT04203160

Public ClinicalTrials.gov record NCT04203160. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 18, 2026, 5:35 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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 identification

NCT ID
NCT04203160
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
University of Michigan Rogel Cancer Center
Other
Enrollment
75 participants

Conditions and interventions

Interventions

  • CPI 613 Drug
  • Cisplatin Drug
  • Gemcitabine Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 22, 2020
Primary completion
Apr 15, 2024
Completion
Apr 28, 2024
Last update posted
Dec 30, 2025

2020 – 2024

United States locations

U.S. sites
10
U.S. states
10
U.S. cities
10
Facility City State ZIP Site status
University of Arizona Cancer Center Tucson Arizona 85724
Northwestern University -- Lurie Comprehensive Cancer Center Chicago Illinois 60611
University of Michigan Rogel Cancer Center Ann Arbor Michigan 48109
Atlantic Health System Morristown New Jersey 07960
University Hospitals - Seidman Cancer Center Cleveland Ohio 44106
Allegheny Health Network Pittsburgh Pennsylvania 15224
Vanderbilt-Ingram Cancer Center Nashville Tennessee 37232
University of Texas Southwestern -- Simmons Comprehensive Cancer Center Dallas Texas 75390
Fred Hutch/University of Washington Cancer Consortium Seattle Washington 98109
University of Wisconsin - Carbone Cancer Center Madison Wisconsin 53705

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04203160, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 30, 2025 · Synced May 18, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04203160 live on ClinicalTrials.gov.

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