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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.

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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

FieldValue
Enrollment Target 13 participants
Start Date 2013-12
Est. Completion 2021-06
Phase Phase 1
Baylor Research Institute

180 total trials

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.

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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Source: ClinicalTrials.gov NCT02021422, the US trial registry maintained by the National Library of Medicine. NCT02021422 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.