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Efficacy of Gembrax Followed by Folfirinox Versus Folfirinox Alone in First Metastatic Line Pancreatic Cancer Patients

Study acronym: GABRINOX2
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Notable Primary completion pushed from Mar 30, 2026 to Dec 30, 2026
    • Study completion pushed from Oct 30, 2027 to Jun 30, 2028
    v12
  2. Minor Publications: details revised at 1 of 7 entriesv11
  3. Minor Eligibility criteria shortened, about 9 words
    • Secondary endpoints revised (7)
    v10
  4. Notable Primary completion date: Mar 30, 2027 to Mar 30, 2026v9 Show 5 more changesShow less
    • Study completion date: Nov 30, 2027 to Oct 30, 2027
    • Interventions: FOLFIRINOX (Combination Product), GABRINOX (Combination Product) to FOLFIRINOX Arm B (Combination Product), GEMBRAX/FOLFIRINOX Arm A (Combination Product)
    • Eligibility criteria expanded, about 138 words
    • Secondary endpoints: details revised at 1 of 7 entries
    • Site contacts updated at 1 of 8 sites
  5. Minor Site details revised at 1 of 8 sitesv8
Show 6 earlier versionsHide 6 earlier versions
  1. Minor Start date: Jan 30, 2022 to Jan 11, 2022
    • Publications: 6 to 7
    v7
  2. Minor Study sites: 6 to 8v6
  3. Minor Site details revised at 3 of 6 sitesv5
  4. Notable Primary completion date: Jul 2023 to Mar 30, 2027
    • Start date: Nov 30, 2021 to Jan 30, 2022
    • Study completion date: Jan 2025 to Nov 30, 2027
    v4
  5. Minor Enrollment target: 210 to 162
    • Study sites: 1 to 6
    • Eligibility criteria shortened, about 29 words
    v3
  6. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Nov 2021 to Nov 30, 2021
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The aim of this study is to evaluate the efficacy of sequential treatment (Gabrinox) comprising Gembrax regimen (Gemcitabine -Abraxane) followed by the Folfirinox regimen (5FU, Oxaliplatin and Irinotecan) compared to folfirinox alone in patients treated in first metastatic line pancreatic cancer
Trial Details
NCT Number NCT05065801
Lead Sponsor Institut du Cancer de Montpellier - Val d'Aurelle
Conditions
(from sponsor)
Metastatic Pancreatic Cancer
Related terms Neoplasms, Pancreatic Neoplasms
Enrollment 162 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov