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NCT05417386 · ClinicalTrials.gov registry record · Phase 1
FOLFIRINOX + NIS793 in Pancreatic Cancer
A Phase 1 study, sponsored by Colin D. Weekes, M.D., PhD.
- Terminated
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
NCT05417386: Clinical Trial Phase 1 study, sponsored by Colin D. Weekes, M.D., PhD.
NCT05417386 is a Phase 1 study that was terminated before completion, run by Colin D. Weekes, M.D., PhD. The registered enrollment target is 4 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05417386, a Phase 1 study, was terminated before completion, sponsored by Colin D. Weekes, M.D., PhD.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
Study Summary
This research is being done to evaluate the safety and effectiveness of the drug NIS793 in combination with the standard of care treatment FOLFIRINOX (consists of the drugs 5-Fluorouracil (5-FU), Oxaliplatin, Irinotecan, and Leucovorin), chemoradiation and surgery for people with metastatic pancreas adenocarcinoma. The drugs involved in this study are: * NIS793 * FOLFIRINOX (consists of the drugs 5-Fluorouracil (5-FU), Oxaliplatin, Irinotecan, and Leucovorin) Other interventions include * chemoradiation * surgery.
Primary Outcome
Primary endpoint of safety run-in cohort is to define the recommended phase 2 dose as analyzed by 2-dimensional imaging (Computed Tomography, CT) or MRI utilizing Response Evaluation Criteria in Solid Tumors (RECIST v.1.1), obtained at 4-cycle therapy intervals.
Interventions
- DRUG Leucovorin
- DRUG 5-Fluorouracil (5-FU)
- DRUG Oxaliplatin
- DRUG Irinotecan
- DRUG FOLFIRINOX
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2022-08-09 |
| Est. Completion | 2023-07-10 |
| Phase | Phase 1 |
Why NCT05417386 stopped before completion
NCT05417386 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 5 interventions - of which Leucovorin is the first listed.
NCT05417386 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05417386 about?
NCT05417386 is a clinical study titled "FOLFIRINOX + NIS793 in Pancreatic Cancer". This research is being done to evaluate the safety and effectiveness of the drug NIS793 in combination with the standard of care treatment FOLFIRINOX (consists of the drugs 5-Fluorouracil (5-FU), Oxaliplatin, Irinotecan, and Leucovorin), chemoradiation and surgery for people with metastatic pancreas...
What is the current status of trial NCT05417386?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2022-08-09. Estimated completion is 2023-07-10.
What interventions are being tested in trial NCT05417386?
The interventions under investigation include: Leucovorin (DRUG), 5-Fluorouracil (5-FU) (DRUG), Oxaliplatin (DRUG), Irinotecan (DRUG), FOLFIRINOX (DRUG).
Who is sponsoring clinical trial NCT05417386?
This trial is sponsored by Colin D. Weekes, M.D., PhD, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05417386's enrollment target sits among peer trials
4 1995th of 2000 higher than 2 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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