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RECRUITING
NCT04926467
PHASE2

Chemotherapy + Anakinra in Patients With Pancreatic Adenocarcinoma (PDAC)

Sponsor: Baylor Research Institute

View on ClinicalTrials.gov

Summary

Based on a central role of inflammation in pancreas cancer, the role of IL 1 in acute and chronic inflammation , the inhibitory effect of IL 1 alfa and beta by anakinra and preliminary experience with anakinra in combination with chemotherapy in metastasis (with FOLFIRINOX) and localized disease (with gemcitabine/abraxane/cisplatin), a phase 2 study with anakinra in combination with perioperative chemotherapy for patients with PDAC is being proposed.

Official title: An Open Label, Phase II Study of Chemotherapy + Anakinra in Patients With Resectable, Locally Advanced or Potentially Resectable Pancreatic Adenocarcinoma (PDAC)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2021-07-23

Completion Date

2027-06

Last Updated

2025-11-10

Healthy Volunteers

No

Interventions

DRUG

Anakinra

Anakinra (100 mg) twice a day (BID), daily, will be self-administered subcutaneously starting on D1 of chemotherapy. Anakinra will be held 2 days prior to surgery. A dosing diary will be given to the patient for anakinra documentation.

Locations (1)

Baylor University Medical Center, Charles A Sammons Cancer Center

Dallas, Texas, United States