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NCT05209074 · ClinicalTrials.gov registry record · Phase 1
Ivosidenib + mFOLFIRINOX in Patients With Resectable Pancreatic Adenocarcinoma
A Phase 1 study of Pancreatic Ductal Adenocarcinoma and Resectable Pancreatic Cancer, sponsored by Case Comprehensive Cancer Center.
- Active
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT05209074: Active Phase 1 study of Pancreatic Ductal Adenocarcinoma and Resectable Pancreatic Cancer, sponsored by Case Comprehensive Cancer Center.
NCT05209074 is a Phase 1 study of Pancreatic Ductal Adenocarcinoma and Resectable Pancreatic Cancer that is active but no longer recruiting, run by Case Comprehensive Cancer Center. The registered enrollment target is 16 participants, below the 600-participant average among 84 other Pancreatic Ductal Adenocarcinoma trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05209074, a Phase 1 study of Pancreatic Ductal Adenocarcinoma and Resectable Pancreatic Cancer, is active but no longer recruiting, sponsored by Case Comprehensive Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is a single-arm, phase I trial, up to 16 participants with resectable PDA. The study will examine the efficacy of the mutant IDH1 inhibitor ivosidenib, in conjunction with standard-of-care mFOLFIRINOX in the neoadjuvant setting.
Primary Outcome
Evaluate by the Bayesian optimal interval (BOIN) strategy to identify the MTD.
Conditions Studied
Interventions
- DRUG mFOLFIRINOX
- DRUG Ivosidenib
Study Locations (1)
Ohio
- University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2022-09-08 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 1 |
What the registry record for NCT05209074 still lists
NCT05209074 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 600-participant average among 84 other Pancreatic Ductal Adenocarcinoma trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with Pancreatic Ductal Adenocarcinoma appearing as the primary indexed condition, and to 2 interventions - of which mFOLFIRINOX is the first listed.
NCT05209074 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT05209074 about?
NCT05209074 is a clinical study titled "Ivosidenib + mFOLFIRINOX in Patients With Resectable Pancreatic Adenocarcinoma". This study is a single-arm, phase I trial, up to 16 participants with resectable PDA. The study will examine the efficacy of the mutant IDH1 inhibitor ivosidenib, in conjunction with standard-of-care mFOLFIRINOX in the neoadjuvant setting.
What is the current status of trial NCT05209074?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2022-09-08. Estimated completion is 2026-12-31.
What conditions does trial NCT05209074 study?
This clinical trial studies the following conditions: Pancreatic Ductal Adenocarcinoma, Resectable Pancreatic Cancer.
What interventions are being tested in trial NCT05209074?
The interventions under investigation include: mFOLFIRINOX (DRUG), Ivosidenib (DRUG).
Who is sponsoring clinical trial NCT05209074?
This trial is sponsored by Case Comprehensive Cancer Center, which has 407 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05209074 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05209074's enrollment target sits among peer trials
16 80th of 84 higher than 4 of 84 other Pancreatic Ductal Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pancreatic Ductal Adenocarcinoma 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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