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A Pilot, Prospective, Non-randomized Evaluation of the Safety of Anakinra Plus Standard Chemotherapy Regimens in Metastatic Pancreatic Ductal Adenocarcinoma Patients
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.
Details
| Lead sponsor | Baylor Research Institute |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 13 |
| Start date | 2013-12 |
| Completion | 2021-06 |
Conditions
- Pancreas Cancer
Interventions
- anakinra
- Oxaliplatin
- Irinotecan
- fluorouracil
Primary outcomes
- The Number of Participants with SAEs and AEs. — 6 months
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).
Countries
United States