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Chemotherapy + Anakinra in Patients With Pancreatic Adenocarcinoma (PDAC)

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Jun 2026 → Jun 2027
See other at-risk trials from Baylor Research Institute

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Jun 2026 to Jun 2027
    • Eligibility criteria expanded, about 47 words
    • Secondary endpoints: details revised at 2 of 7 entries
  2. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary completion date: Jun 2025 to Jun 2026
    • Study completion date: Jun 2026 to Jun 2027
    • Start date changed from estimate of Jun 2021 to Jul 23, 2021
    • Site details revised
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04926467
Lead Sponsor Baylor Research Institute
Conditions
(from sponsor)		 Pancreatic Adenocarcinoma
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov