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Evaluating NALIRIFOX vs Modified Gemcitabine, Nab-Paclitaxel and Cisplatin in Patients With Locally Advanced and Metastatic Pancreatic Adenocarcinoma

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study sites: 1 to 2v5
  2. Notable Start date: Nov 7, 2025 to Apr 2, 2026v4
  3. Notable Trial status: Not Yet Recruiting to Recruiting Primary completion date: Mar 2026 to May 2028 · Completion date: Mar 2027 to Nov 2029 · Start date changed from estimate of Jan 1, 2026 to Nov 7, 2025 · 1 morev3 Show 4 more changesShow less
    • Primary completion date: Mar 2026 to May 2028
    • Completion date: Mar 2027 to Nov 2029
    • Start date changed from estimate of Jan 1, 2026 to Nov 7, 2025
    • Site details revised
  4. Notable Start date: Sep 2025 to Jan 1, 2026 Study description shortened, about 8 words · Eligibility criteria expanded, about 3 wordsv2 Show 2 more changesShow less
    • Study description shortened, about 8 words
    • Eligibility criteria expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  5. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a single-center, open-label, randomized Phase 2 trial to evaluate the efficacy of NALIRIFOX (Arm 1) vs mGAP (Arm 2) in previously untreated patients with locally advanced (unresectable) and metastatic pancreatic ductal adenocarcinoma (PDAC).
Trial Details
NCT Number NCT07076212
Lead Sponsor Medical University of South Carolina
Conditions Metastatic Pancreatic Adenocarcinoma, Locally Advanced Pancreatic Adenocarcinoma
Enrollment 52 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov