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NCT05325281 · ClinicalTrials.gov registry record · Phase 1
CPI-613 (Devimistat) in Combination With Chemoradiation in Patients With Pancreatic Adenocarcinoma
A Phase 1 study, sponsored by Medical College of Wisconsin.
- Terminated
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT05325281: Clinical Trial Phase 1 study, sponsored by Medical College of Wisconsin.
NCT05325281 is a Phase 1 study that was terminated before completion, run by Medical College of Wisconsin. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05325281, a Phase 1 study, was terminated before completion, sponsored by Medical College of Wisconsin.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
This is a single-center, open-label, phase I study designed to determine the maximum tolerated dose (MTD) and safety profile of CPI-613® when used concomitantly with chemoradiation for local control of pancreatic adenocarcinoma (PDAC).
Primary Outcome
MTD will be determined by testing increasing doses of CPI-613®, starting from 500 mg/m\^2 and up to 1,500 mg/m\^2, on dose escalation cohorts of three patients (maximum 24 patients) in combination with Gem-RT therapy. MTD reflects the highest drug dose that does not cause unacceptable adverse effects.
Interventions
- DRUG CPI-613® (Dose level -1.0 250 mg/m^2)
- DRUG CPI-613® (Dose level 1.0 500 mg/m^2)
- DRUG CPI-613® (Dose level 2.0 1,000 mg/m^2)
- DRUG CPI-613® (Dose level 3.0 1,500 mg/m^2)
- DRUG CPI-613® Maximum Tolerated Dose (MTD)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2022-10-31 |
| Est. Completion | 2025-07-08 |
| Phase | Phase 1 |
Why NCT05325281 stopped before completion
NCT05325281 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 5 interventions - of which CPI-613® (Dose level -1.0 250 mg/m^2) is the first listed.
NCT05325281 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05325281 about?
NCT05325281 is a clinical study titled "CPI-613 (Devimistat) in Combination With Chemoradiation in Patients With Pancreatic Adenocarcinoma". This is a single-center, open-label, phase I study designed to determine the maximum tolerated dose (MTD) and safety profile of CPI-613® when used concomitantly with chemoradiation for local control of pancreatic adenocarcinoma (PDAC).
What is the current status of trial NCT05325281?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2022-10-31. Estimated completion is 2025-07-08.
What interventions are being tested in trial NCT05325281?
The interventions under investigation include: CPI-613® (Dose level -1.0 250 mg/m^2) (DRUG), CPI-613® (Dose level 1.0 500 mg/m^2) (DRUG), CPI-613® (Dose level 2.0 1,000 mg/m^2) (DRUG), CPI-613® (Dose level 3.0 1,500 mg/m^2) (DRUG), CPI-613® Maximum Tolerated Dose (MTD) (DRUG).
Who is sponsoring clinical trial NCT05325281?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05325281's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 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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