At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 13 enrolled
Drug / intervention
anakinra +3 moredrug
Likely dose
anakinra 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Pilot, Prospective, Non-randomized Evaluation of the Safety of Anakinra Plus Standard Chemotherapy Regimens in Metastatic Pancreatic Ductal Adenocarcinoma Patients
In Brief
A Phase 1 clinical trial evaluating anakinra, Oxaliplatin, and 2 other interventions for Pancreas Cancer. Completed, enrolled 13 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPancreas Cancer
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartDec 2013
First PostedDec 2013
Primary CompletionDec 2017
Study CompletionJun 2021
TodayJul 2026
First PostedDec 27, 2013
Enrollment StartDec 1, 2013
Primary CompletionDec 1, 2017
Study CompletionJun 1, 2021
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 12.5 years ago
Interventions
anakinradrug
Dosage Route Administration 100 mg SC Every Other Day
Oxaliplatindrug
Oxaliplatin 85 mg/m2 2-4 hours
Irinotecandrug
Irinotecan 180 mg/m2 90 minutes
fluorouracildrug
fluorouracil 2400 mg/m2 48 hours