deltatrials
Active Not Recruiting PHASE3 INTERVENTIONAL 2-arm NCT03829462

Assessing a Regorafenib-irinotecan Combination Versus Regorafenib Alone in Metastatic Colorectal Cancer Patients (NEXT-REGIRI)

A Randomized Phase III Trial Assessing a Regorafenib-irinotecan Combination (REGIRI) Versus Regorafenib Alone in Metastatic Colorectal Cancer Patients After Failure of Standard Therapies, According to the A/A Genotype of Cyclin D1

Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

Conditions Metastatic Colorectal Cancer (mCRC)
Interventions Irinotecan Regorafenib
Updated 18 times since 2019 Last updated: Nov 14, 2025 Started: Mar 28, 2019 Primary completion: Sep 4, 2024 Completion: Sep 30, 2026
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on Metastatic Colorectal Cancer (mCRC), this trial is ongoing. The trial is conducted by Institut du Cancer de Montpellier - Val d'Aurelle and has accumulated 18 data snapshots since 2019. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~Mar 2019 – ~Apr 2019 · 31 days · monthly snapshot~Apr 2019 – ~May 2019 · 30 days · monthly snapshot~May 2019 – ~Jun 2019 · 31 days · monthly snapshot~Jun 2019 – ~Jul 2020 · 13 months · monthly snapshot~Jul 2020 – ~Jan 2021 · 6 months · monthly snapshot~Jan 2021 – ~May 2021 · 4 months · monthly snapshot~May 2021 – ~Jun 2021 · 31 days · monthly snapshot~Jun 2021 – ~Jan 2022 · 7 months · monthly snapshot~Jan 2022 – ~Dec 2022 · 11 months · monthly snapshot~Dec 2022 – ~Feb 2023 · 2 months · monthly snapshot~Feb 2023 – ~Aug 2023 · 6 months · monthly snapshot~Aug 2023 – ~Oct 2023 · 2 months · monthly snapshot~Oct 2023 – ~Jul 2024 · 9 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Oct 2024 · 30 days · monthly snapshot~Oct 2024 – ~Aug 2025 · 10 months · monthly snapshot~Aug 2025 – ~Dec 2025 · 4 months · monthly snapshot~Dec 2025 – present · 7 months · monthly snapshot

Change History

18 versions recorded

  1. Dec 2025 — Present [monthly]

    Active Not Recruiting PHASE3

  2. Aug 2025 — Dec 2025 [monthly]

    Active Not Recruiting PHASE3

  3. Oct 2024 — Aug 2025 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  4. Sep 2024 — Oct 2024 [monthly]

    Recruiting PHASE3

  5. Jul 2024 — Sep 2024 [monthly]

    Recruiting PHASE3

▶ Show 13 earlier versions

  1. Oct 2023 — Jul 2024 [monthly]

    Recruiting PHASE3

  2. Aug 2023 — Oct 2023 [monthly]

    Recruiting PHASE3

  3. Feb 2023 — Aug 2023 [monthly]

    Recruiting PHASE3

  4. Dec 2022 — Feb 2023 [monthly]

    Recruiting PHASE3

  5. Jan 2022 — Dec 2022 [monthly]

    Recruiting PHASE3

  6. Jun 2021 — Jan 2022 [monthly]

    Recruiting PHASE3

  7. May 2021 — Jun 2021 [monthly]

    Recruiting PHASE3

  8. Jan 2021 — May 2021 [monthly]

    Recruiting PHASE3

  9. Jul 2020 — Jan 2021 [monthly]

    Recruiting PHASE3

  10. Jun 2019 — Jul 2020 [monthly]

    Recruiting PHASE3

  11. May 2019 — Jun 2019 [monthly]

    Recruiting PHASE3

    Status: Not Yet Recruiting → Recruiting

  12. Apr 2019 — May 2019 [monthly]

    Not Yet Recruiting PHASE3

  13. Mar 2019 — Apr 2019 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Institut du Cancer de Montpellier - Val d'Aurelle
Data source: Institut du Cancer de Montpellier - Val d'Aurelle

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations