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A Pilot, Prospective, Non-randomized Evaluation of the Safety of Anakinra Plus Standard Chemotherapy

NCT02021422 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2026-02-18

No results posted yet for this 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.

Conditions

  • Pancreas Cancer

Interventions

DRUG

anakinra

Dosage Route Administration 100 mg SC Every Other Day

DRUG

Oxaliplatin

Oxaliplatin 85 mg/m2 2-4 hours

DRUG

Irinotecan

Irinotecan 180 mg/m2 90 minutes

DRUG

fluorouracil

fluorouracil 2400 mg/m2 48 hours

Sponsors & Collaborators

  • Baylor Research Institute

    lead OTHER

Principal Investigators

  • Carlos Becerra, MD · Baylor Sammons Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2017-12-31
Completion
2021-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02021422 on ClinicalTrials.gov