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NCT04203160 · ClinicalTrials.gov registry record · Phase 1
Gemcitabine and Cisplatin With or Without CPI-613 as First Line Therapy for Patients With Advanced Unresectable Biliary Tract Cancer (BilT-04)
A Phase 1 study, sponsored by University of Michigan Rogel Cancer Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 75
- Enrollment target
NCT04203160: Clinical Trial Phase 1 study, sponsored by University of Michigan Rogel Cancer Center.
NCT04203160 is a Phase 1 study that was terminated before completion, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 75 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04203160, a Phase 1 study, was terminated before completion, sponsored by University of Michigan Rogel Cancer Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 75 participants
- Enrollment target
Study 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.
Primary Outcome
Dose limiting toxicities will determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of combination therapy with CPI-613 + gemcitabine and cisplatin. Assessed using the NCI CTCAE v5.0
Interventions
- DRUG Cisplatin
- DRUG Gemcitabine
- DRUG CPI 613
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2020-06-23 |
| Est. Completion | 2024-04-29 |
| Phase | Phase 1 |
Why NCT04203160 stopped before completion
NCT04203160 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% higher).
The record links to 0 conditions, and to 3 interventions - of which Cisplatin is the first listed.
NCT04203160 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04203160 about?
NCT04203160 is a clinical study titled "Gemcitabine and Cisplatin With or Without CPI-613 as First Line Therapy for Patients With Advanced Unresectable Biliary Tract Cancer (BilT-04)". 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 s...
What is the current status of trial NCT04203160?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 75 participants. The study started on 2020-06-23. Estimated completion is 2024-04-29.
What interventions are being tested in trial NCT04203160?
The interventions under investigation include: Cisplatin (DRUG), Gemcitabine (DRUG), CPI 613 (DRUG).
Who is sponsoring clinical trial NCT04203160?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04203160's enrollment target sits among peer trials
75 711th of 2000 higher than 1,276 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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