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NCT03699319 · ClinicalTrials.gov registry record · Phase 1
CPI-613 in Combination With Modified FOLFIRINOX in Locally Advanced Pancreatic Cancer
A Phase 1 study, sponsored by David Bajor, MD.
- Completed
- Registry status
- Phase 1
- Development phase
- 49
- Enrollment target
NCT03699319: Completed Phase 1 study, sponsored by David Bajor, MD.
NCT03699319 is a Phase 1 study that has completed, run by David Bajor, MD. The registered enrollment target is 49 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03699319, a Phase 1 study, has completed, sponsored by David Bajor, MD.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 49 participants
- Enrollment target
Study Summary
The purpose of this study is to treat participants with the combination of CPI-613 (the study drug) with FOLFIRINOX (the standard combination of drugs) to determine if it is safe and effective for participants with localized and unresectable pancreatic cancer. This study is specifically for participants who have a pancreatic cancer that is localized and not considered resectable or removable by a surgeon, without additional treatment.
Primary Outcome
Interval between enrollment and death for participants for all participants. Median OS will be estimated using the Kaplan-Meier method along with a two-sided 80% confidence interval (CI). OS will be documented and reported separately per cohort
Interventions
- DRUG Oxaliplatin
- DRUG Irinotecan
- DRUG Folinic acid
- DRUG CPI 613
- DRUG 5-flurouracil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2018-12-07 |
| Est. Completion | 2024-09-23 |
| Phase | Phase 1 |
What the finished NCT03699319 record still lists
NCT03699319 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% lower).
The record links to 0 conditions, and to 5 interventions - of which Oxaliplatin is the first listed.
NCT03699319 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03699319 about?
NCT03699319 is a clinical study titled "CPI-613 in Combination With Modified FOLFIRINOX in Locally Advanced Pancreatic Cancer". The purpose of this study is to treat participants with the combination of CPI-613 (the study drug) with FOLFIRINOX (the standard combination of drugs) to determine if it is safe and effective for participants with localized and unresectable pancreatic cancer. This study is specifically for particip...
What is the current status of trial NCT03699319?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 49 participants. The study started on 2018-12-07. Estimated completion is 2024-09-23.
What interventions are being tested in trial NCT03699319?
The interventions under investigation include: Oxaliplatin (DRUG), Irinotecan (DRUG), Folinic acid (DRUG), CPI 613 (DRUG), 5-flurouracil (DRUG).
Who is sponsoring clinical trial NCT03699319?
This trial is sponsored by David Bajor, MD, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03699319's enrollment target sits among peer trials
49 1017th of 2000 higher than 976 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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