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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04203160
The ClinicalTrials.gov registry entry for NCT04203160 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan Rogel Cancer Center, which has 292 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Cisplatin is the first listed.
NCT04203160 reports 0 study locations.
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.
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