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NCT02021422 · ClinicalTrials.gov registry record · Phase 1
A Pilot, Prospective, Non-randomized Evaluation of the Safety of Anakinra Plus Standard Chemotherapy
A Phase 1 study, sponsored by Baylor Research Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT02021422: Completed Phase 1 study, sponsored by Baylor Research Institute.
NCT02021422 is a Phase 1 study that has completed, run by Baylor Research Institute. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02021422, a Phase 1 study, has completed, sponsored by Baylor Research Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
Study Summary
The study's overall objectives are to evaluate the safety of anakinra in combination with standard chemotherapy regimens in patients with pancreatic ductal adenocarinoma, as well as to collect preliminary immune modulation and clinical activity information, overall survival, and serious adverse events related to the study drug.
Primary Outcome
Test the safety of Anakinra in combination with standard chemotherapy in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) as evidenced by the Number of Participants with serious adverse events (SAEs) and adverse events (AEs).
Interventions
- DRUG Oxaliplatin
- DRUG Irinotecan
- DRUG anakinra
- DRUG fluorouracil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2013-12 |
| Est. Completion | 2021-06 |
| Phase | Phase 1 |
What the finished NCT02021422 record still lists
NCT02021422 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 4 interventions - of which Oxaliplatin is the first listed.
NCT02021422 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02021422 about?
NCT02021422 is a clinical study titled "A Pilot, Prospective, Non-randomized Evaluation of the Safety of Anakinra Plus Standard Chemotherapy". The study's overall objectives are to evaluate the safety of anakinra in combination with standard chemotherapy regimens in patients with pancreatic ductal adenocarinoma, as well as to collect preliminary immune modulation and clinical activity information, overall survival, and serious adverse even...
What is the current status of trial NCT02021422?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2013-12. Estimated completion is 2021-06.
What interventions are being tested in trial NCT02021422?
The interventions under investigation include: Oxaliplatin (DRUG), Irinotecan (DRUG), anakinra (DRUG), fluorouracil (DRUG).
Who is sponsoring clinical trial NCT02021422?
This trial is sponsored by Baylor Research Institute, which has 180 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02021422's enrollment target sits among peer trials
13 1847th of 2000 higher than 149 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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