deltatrials
Terminated PHASE3 INTERVENTIONAL 2-arm NCT03773302

Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations

A Phase 3 Multicenter, Open-Label, Randomized, Controlled Study of Oral Infigratinib Versus Gemcitabine With Cisplatin in Subjects With Advanced/Metastatic or Inoperable Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations: The PROOF Trial

Sponsor: Helsinn Healthcare SA

Conditions Advanced Cholangiocarcinoma FGFR2 Gene Mutation
Interventions BGJ398 Cisplatin Gemcitabine
Updated 25 times since 2019 Last updated: Apr 15, 2024 Started: Dec 27, 2019 Primary completion: Mar 2, 2023 Completion: Mar 2, 2023
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

The sponsor has decided to close the study due to the discontinuation of infigratinib development in oncology within the sponsor's territory. The discontinuation of the study was not due to safety issues.

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A PHASE3 clinical study on Advanced Cholangiocarcinoma and FGFR2 Gene Mutation, this trial is terminated or withdrawn. The trial is conducted by Helsinn Healthcare SA and has accumulated 25 data snapshots since 2019. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~Jan 2019 – ~Mar 2019 · 59 days · monthly snapshot~Mar 2019 – ~Apr 2019 · 31 days · monthly snapshot~Apr 2019 – ~May 2019 · 30 days · monthly snapshot~May 2019 – ~Feb 2020 · 9 months · monthly snapshot~Feb 2020 – ~Apr 2020 · 2 months · monthly snapshot~Apr 2020 – ~May 2020 · 30 days · monthly snapshot~May 2020 – ~Jul 2020 · 2 months · monthly snapshot~Jul 2020 – ~Aug 2020 · 31 days · monthly snapshot~Aug 2020 – ~Nov 2020 · 3 months · monthly snapshot~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Sep 2021 · 7 months · monthly snapshot~Sep 2021 – ~Nov 2021 · 2 months · monthly snapshot~Nov 2021 – ~Dec 2021 · 30 days · monthly snapshot~Dec 2021 – ~Apr 2022 · 4 months · monthly snapshot~Apr 2022 – ~May 2022 · 30 days · monthly snapshot~May 2022 – ~Sep 2022 · 4 months · monthly snapshot~Sep 2022 – ~Nov 2022 · 2 months · monthly snapshot~Nov 2022 – ~May 2023 · 6 months · monthly snapshot~May 2023 – ~Jun 2024 · 13 months · monthly snapshot~Jun 2024 – ~Jul 2024 · 30 days · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – ~Dec 2025 · 3 months · monthly snapshot~Dec 2025 – present · 7 months · monthly snapshot

Change History

25 versions recorded

  1. Dec 2025 — Present [monthly]

    Terminated PHASE3

  2. Sep 2025 — Dec 2025 [monthly]

    Terminated PHASE3

  3. Sep 2024 — Sep 2025 [monthly]

    Terminated PHASE3

  4. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE3

  5. Jun 2024 — Jul 2024 [monthly]

    Terminated PHASE3

▶ Show 20 earlier versions

  1. May 2023 — Jun 2024 [monthly]

    Terminated PHASE3

    Status: Active Not Recruiting → Terminated

  2. Nov 2022 — May 2023 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  3. Sep 2022 — Nov 2022 [monthly]

    Recruiting PHASE3

  4. May 2022 — Sep 2022 [monthly]

    Recruiting PHASE3

  5. Apr 2022 — May 2022 [monthly]

    Recruiting PHASE3

  6. Dec 2021 — Apr 2022 [monthly]

    Recruiting PHASE3

  7. Nov 2021 — Dec 2021 [monthly]

    Recruiting PHASE3

  8. Sep 2021 — Nov 2021 [monthly]

    Recruiting PHASE3

  9. Feb 2021 — Sep 2021 [monthly]

    Recruiting PHASE3

  10. Jan 2021 — Feb 2021 [monthly]

    Recruiting PHASE3

  11. Nov 2020 — Jan 2021 [monthly]

    Recruiting PHASE3

  12. Aug 2020 — Nov 2020 [monthly]

    Recruiting PHASE3

  13. Jul 2020 — Aug 2020 [monthly]

    Recruiting PHASE3

  14. May 2020 — Jul 2020 [monthly]

    Recruiting PHASE3

  15. Apr 2020 — May 2020 [monthly]

    Recruiting PHASE3

  16. Feb 2020 — Apr 2020 [monthly]

    Recruiting PHASE3

  17. May 2019 — Feb 2020 [monthly]

    Recruiting PHASE3

  18. Apr 2019 — May 2019 [monthly]

    Recruiting PHASE3

    Status: Not Yet Recruiting → Recruiting

  19. Mar 2019 — Apr 2019 [monthly]

    Not Yet Recruiting PHASE3

  20. Jan 2019 — Mar 2019 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Helsinn Healthcare SA
  • QED Therapeutics, a BridgeBio company
Data source: QED Therapeutics, a BridgeBio company

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

Study Locations

Adelaide, Australia , Almada, Portugal , Badalona, Spain , Bangkok, Thailand , Barcelona, Spain , Bebington, United Kingdom , Beijing, China , Bentleigh East, Australia , Boston, United States , Brussels, Belgium and 78 more locations