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NCT05546411 · ClinicalTrials.gov registry record · Phase 2
A Trial of NIS793 With FOLFIRINOX in Pancreatic Cancer
A Phase 2 study, sponsored by Kimberly Perez, MD.
- Terminated
- Registry status
- Phase 2
- Development phase
- 8
- Enrollment target
NCT05546411: Clinical Trial Phase 2 study, sponsored by Kimberly Perez, MD.
NCT05546411 is a Phase 2 study that was terminated before completion, run by Kimberly Perez, MD. The registered enrollment target is 8 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05546411, a Phase 2 study, was terminated before completion, sponsored by Kimberly Perez, MD.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 8 participants
- Enrollment target
Study Summary
This study is being done to evaluate the safety and efficacy of adding NIS793 to standard of care FOLFIRINOX treatment for pancreatic cancer. The names of the study interventions involved in this study are: * NIS793 * FOLFIRINOX (Folinic acid/Leucovorin, 5-Fluorouracil, Irinotecan, and Oxaliplatin) Other interventions may include: * Chemoradiation Therapy * Surgery
Primary Outcome
Major pathological response (MPR) defined as \<5% residual tumor cells visible in the pancreatic resection specimen. The major pathological response rate will be analyzed among all patients who start protocol therapy, including those not resected due to early progression, death or off study.
Interventions
- DRUG Leucovorin
- DRUG 5-Fluorouracil (5-FU)
- DRUG Oxaliplatin
- DRUG mFOLFIRINOX
- DRUG Irinotecan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2023-01-06 |
| Est. Completion | 2023-10-13 |
| Phase | Phase 2 |
Why NCT05546411 stopped before completion
NCT05546411 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 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 5 interventions - of which Leucovorin is the first listed.
NCT05546411 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05546411 about?
NCT05546411 is a clinical study titled "A Trial of NIS793 With FOLFIRINOX in Pancreatic Cancer". This study is being done to evaluate the safety and efficacy of adding NIS793 to standard of care FOLFIRINOX treatment for pancreatic cancer. The names of the study interventions involved in this study are: * NIS793 * FOLFIRINOX (Folinic acid/Leucovorin, 5-Fluorouracil, Irinotecan, and Oxaliplatin...
What is the current status of trial NCT05546411?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2023-01-06. Estimated completion is 2023-10-13.
What interventions are being tested in trial NCT05546411?
The interventions under investigation include: Leucovorin (DRUG), 5-Fluorouracil (5-FU) (DRUG), Oxaliplatin (DRUG), mFOLFIRINOX (DRUG), Irinotecan (DRUG).
Who is sponsoring clinical trial NCT05546411?
This trial is sponsored by Kimberly Perez, MD, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05546411's enrollment target sits among peer trials
8 1990th of 2000 higher than 5 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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