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Assessing a Regorafenib-irinotecan Combination Versus Regorafenib Alone in Metastatic Colorectal Cancer Patients

Study acronym: NEXT-REGIRI
StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. Study completion date: Sep 2025 to Sep 2026v16
  2. Results first posted: Jul 18, 2025v15 Show 5 more changesShow less
    • Enrollment target: 66 to 377
    • Eligibility criteria expanded, about 20 words
    • Secondary endpoints revised (6)
    • Primary endpoint revised
    • Study description shortened, about 161 words
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 78 to confirmed 66
    • Primary completion date changed from estimate of Oct 2024 to Sep 4, 2024
    • Site details revised at 11 of 11 sites
    v14
  4. Re-verified, no change to tracked fieldsv13
  5. Study completion date: Oct 2024 to Sep 2025v12
Show 10 earlier versionsHide 10 earlier versions
  1. Primary and study completion dates: Aug 2024 to Oct 2024v11
  2. Primary and study completion dates: Aug 2023 to Aug 2024v10
  3. Primary completion date: Jun 2022 to Aug 2023
    • Study sites: 12 to 11
    • Study completion date: Jun 2023 to Aug 2023
    • Eligibility criteria expanded, about 8 words
    v9
  4. Study sites: 1 to 12v8
  5. Eligibility criteria expanded, about 33 words
    • Secondary endpoints: 5 to 6
    v7
  6. Re-verified, no change to tracked fieldsv6
  7. Start date changed from estimate of Apr 2019 to Mar 28, 2019v5
  8. Secondary endpoints: details revised at 5 of 5 entriesv4
  9. Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Jun 2021 to Jun 2022
    • Study completion date: Jun 2022 to Jun 2023
    • Site details revised
    v3
  10. Start date: Feb 2019 to Apr 2019v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Patients with metastatic colorectal cancer (mCRC) who have received all approved standard treatments (except Regorafenib and Lonsurf) no longer have treatment options available while maintaining a good performance status which would allow them to receive a new treatment
Trial Details
NCT Number NCT03829462
Lead Sponsor Institut du Cancer de Montpellier - Val d'Aurelle
Conditions
(from sponsor)		 Metastatic Colorectal Cancer (mCRC)
Related terms Colorectal Neoplasms
Enrollment 377 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov