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NCT07214298 · ClinicalTrials.gov registry record · Phase 1
Pegcetacoplan in Combination With Modified FOLFIRINOX for the Treatment of Metastatic Pancreatic Ductal Adenocarcinoma
A Phase 1 study of Stage IV Pancreatic Cancer AJCC v8 and Metastatic Pancreatic Ductal Adenocarcinoma, sponsored by Roswell Park Cancer Institute.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
- 1
- Study location
NCT07214298: Recruiting Phase 1 study of Stage IV Pancreatic Cancer AJCC v8 and Metastatic Pancreatic Ductal Adenocarcinoma, sponsored by Roswell Park Cancer Institute.
NCT07214298 is a Phase 1 study of Stage IV Pancreatic Cancer AJCC v8 and Metastatic Pancreatic Ductal Adenocarcinoma that is actively recruiting participants, run by Roswell Park Cancer Institute. The registered enrollment target is 35 participants, below the 88-participant average among 31 other Stage IV Pancreatic Cancer AJCC v8 trials with a reported enrollment target (60% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07214298, a Phase 1 study of Stage IV Pancreatic Cancer AJCC v8 and Metastatic Pancreatic Ductal Adenocarcinoma, is actively recruiting participants, sponsored by Roswell Park Cancer Institute.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I/II trial tests the effect of pegcetacoplan in combination with oxaliplatin, irinotecan, leucovorin, and fluorouracil (mFOLFIRINOX) in treating patients with pancreatic ductal adenocarcinoma (PDAC) that has spread from where it first started (primary site) to other places in the body (metastatic). Pegcetacoplan works by targeting the immune complement process, a part of the immune system that defends against bacteria and may limit tumor progression and improve the immune system's response against tumor cells. Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It damages the cell's deoxyribonucleic acid (DNA) and may kill tumor cells. Irinotecan is in a class of antineoplastic medications called topoisomerase I inhibitors. It blocks a certain enzyme needed for cell division and DNA repair and may kill tumor cells. Leucovorin is a drug used to lessen the toxic effects of substances that block the action of folic acid. Leucovorin is a form of folic acid. It is a type of chemoprotective agent and a type of chemosensitizing agent. Fluorouracil stops cells from making DNA and it may kill tumor cells. It is a type of antimetabolite. Giving pegcetacoplan in combination with mFOLFIRINOX may be safe, tolerable, and/or effecting in treating patients with metastatic PDAC. This trial also evaluates the effect of pegcetacoplan on the incidence of major thrombotic events and the resulting complications. Thrombosis is a common complication in patients with PDAC. Thrombosis occurs when blood clots block veins or arteries. Complications of thrombosis, such as stroke or heart attack, can be life-threatening. Giving pegcetacoplan may help prevent blood clots from forming and decrease the risk of major thrombotic events.
Primary Outcome
Will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 criteria. Will be defined as any grade 3 or higher AE possibly, or definitely related to pegcetacoplan only. Will be summarized as the proportion of evaluable patients with 95% Clopper-Pearson confidence interval.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- DRUG Fluorouracil
- PROCEDURE Biopsy Procedure
- DRUG Irinotecan
Study Locations (1)
New York
- Roswell Park Cancer Institute - Buffalo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2026-03-01 |
| Est. Completion | 2028-10-01 |
| Phase | Phase 1 |
What NCT07214298 shows while recruiting
NCT07214298 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 88-participant average among 31 other Stage IV Pancreatic Cancer AJCC v8 trials with a reported enrollment target (60% lower).
The record links to 2 conditions, with Stage IV Pancreatic Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT07214298 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT07214298 about?
NCT07214298 is a clinical study titled "Pegcetacoplan in Combination With Modified FOLFIRINOX for the Treatment of Metastatic Pancreatic Ductal Adenocarcinoma". This phase I/II trial tests the effect of pegcetacoplan in combination with oxaliplatin, irinotecan, leucovorin, and fluorouracil (mFOLFIRINOX) in treating patients with pancreatic ductal adenocarcinoma (PDAC) that has spread from where it first started (primary site) to other places in the body (me...
What is the current status of trial NCT07214298?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2026-03-01. Estimated completion is 2028-10-01.
What conditions does trial NCT07214298 study?
This clinical trial studies the following conditions: Stage IV Pancreatic Cancer AJCC v8, Metastatic Pancreatic Ductal Adenocarcinoma.
What interventions are being tested in trial NCT07214298?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Fluorouracil (DRUG), Biopsy Procedure (PROCEDURE), Irinotecan (DRUG).
Who is sponsoring clinical trial NCT07214298?
This trial is sponsored by Roswell Park Cancer Institute, which has 365 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07214298 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07214298's enrollment target sits among peer trials
35 19th of 31 higher than 13 of 31 other Stage IV Pancreatic Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage IV Pancreatic Cancer AJCC v8 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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