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NAPOLI-2: Fluorouracil, Leucovorin, and Nanoliposomal Irinotecan in Biliary Cancer

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 50 to confirmed 48 · Primary completion date changed from estimate of Dec 30, 2025 to Sep 3, 2025 · Completion date: Dec 31, 2025 to Dec 31, 2026 · 1 morev12 Show 4 more changesShow less
    • Enrollment target: estimated 50 to confirmed 48
    • Primary completion date changed from estimate of Dec 30, 2025 to Sep 3, 2025
    • Completion date: Dec 31, 2025 to Dec 31, 2026
    • Site details revised at 4 of 4 sites
  2. Primary completion date: Apr 30, 2025 to Dec 30, 2025v11
  3. Enrollment target: 44 to 50 Site details revised at 1 of 4 sitesv10 Show 1 more changeShow less
    • Site details revised at 1 of 4 sites
  4. Primary completion date: May 30, 2024 to Apr 30, 2025 Completion date: Jul 31, 2024 to Dec 31, 2025 · Site details revised at 2 of 4 sitesv9 Show 2 more changesShow less
    • Completion date: Jul 31, 2024 to Dec 31, 2025
    • Site details revised at 2 of 4 sites
  5. Primary completion date: Nov 30, 2023 to May 30, 2024 Study sites: 3 to 4 · Secondary endpoints revised (7)v8 Show 2 more changesShow less
    • Study sites: 3 to 4
    • Secondary endpoints revised (7)

    See this version in full on ClinicalTrials.gov ↗

Show 6 earlier versionsHide 6 earlier versions
  1. Primary completion date: Nov 30, 2022 to Nov 30, 2023 Completion date: Jul 31, 2023 to Jul 31, 2024v7 Show 1 more changeShow less
    • Completion date: Jul 31, 2023 to Jul 31, 2024
  2. Primary completion date: Jul 31, 2022 to Nov 30, 2022v6
  3. Primary completion date: Jul 31, 2021 to Jul 31, 2022 Study sites: 1 to 3 · Completion date: Jul 31, 2022 to Jul 31, 2023v5 Show 2 more changesShow less
    • Study sites: 1 to 3
    • Completion date: Jul 31, 2022 to Jul 31, 2023
  4. Site contact updatedv4
  5. Re-verified, no change to tracked fieldsv3
  6. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1v2 Show 1 more changeShow less
    • Study sites: 0 to 1
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 study to evaluate the clinical activity of the combination of fluorouracil, leucovorin, and nanoliposomal irinotecan as second-line treatment in patients with advanced biliary tract cancers following gemcitabine and platinum chemotherapy.
Trial Details
NCT Number NCT04005339
Lead Sponsor Georgetown University
Collaborators: Ipsen
Conditions Advanced Biliary Tract Cancer
Enrollment 48 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov