deltatrials
Completed PHASE1/PHASE2 INTERVENTIONAL 11-arm NCT02325739

FGF401 in HCC and Solid Tumors Characterized by Positive FGFR4 and KLB Expression

A Phase I/II, Multicenter, Open-label Study of Oral FGF401 in Adult Patients With Hepatocellular Carcinoma or Solid Malignancies Characterized by Positive FGFR4 and KLB Expression

Sponsor: Novartis Pharmaceuticals

Interventions FGF401 PDR001
Updated 23 times since 2017 Last updated: Sep 30, 2024 Started: Dec 29, 2014 Primary completion: May 30, 2019 Completion: May 30, 2019
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE1/PHASE2 clinical study on Hepatocellular Carcinoma (HCC) and Solid Malignancies, this trial is completed. The trial is conducted by Novartis Pharmaceuticals and has accumulated 23 data snapshots since 2014. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Jun 2017 · 4 months · monthly snapshot~Jun 2017 – ~Dec 2017 · 6 months · monthly snapshot~Dec 2017 – ~Mar 2018 · 3 months · monthly snapshot~Mar 2018 – ~Jun 2018 · 3 months · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Sep 2018 · 2 months · monthly snapshot~Sep 2018 – ~Nov 2018 · 2 months · monthly snapshot~Nov 2018 – ~Dec 2018 · 30 days · monthly snapshot~Dec 2018 – ~Feb 2019 · 2 months · monthly snapshot~Feb 2019 – ~Apr 2019 · 59 days · monthly snapshot~Apr 2019 – ~May 2019 · 30 days · monthly snapshot~May 2019 – ~Jun 2019 · 31 days · monthly snapshot~Jun 2019 – ~Sep 2019 · 3 months · monthly snapshot~Sep 2019 – ~Feb 2020 · 5 months · monthly snapshot~Feb 2020 – ~Mar 2020 · 29 days · monthly snapshot~Mar 2020 – ~Jan 2021 · 10 months · monthly snapshot~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Nov 2024 · 2 months · monthly snapshot~Nov 2024 – ~Sep 2025 · 10 months · monthly snapshot~Sep 2025 – ~Dec 2025 · 3 months · monthly snapshot~Dec 2025 – present · 9 months · monthly snapshot

Change History

23 versions recorded
  1. Dec 2025 — Present [monthly]

    Completed PHASE1/PHASE2

  2. Sep 2025 — Dec 2025 [monthly]

    Completed PHASE1/PHASE2

  3. Nov 2024 — Sep 2025 [monthly]

    Completed PHASE1/PHASE2

  4. Sep 2024 — Nov 2024 [monthly]

    Completed PHASE1/PHASE2

  5. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1/PHASE2

    Phase: PHASE1_PHASE2PHASE1/PHASE2

Show 18 earlier versions
  1. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE1_PHASE2

  2. Mar 2020 — Jan 2021 [monthly]

    Completed PHASE1_PHASE2

  3. Feb 2020 — Mar 2020 [monthly]

    Completed PHASE1_PHASE2

  4. Sep 2019 — Feb 2020 [monthly]

    Completed PHASE1_PHASE2

    Status: Active Not RecruitingCompleted

  5. Jun 2019 — Sep 2019 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  6. May 2019 — Jun 2019 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  7. Apr 2019 — May 2019 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  8. Feb 2019 — Apr 2019 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  9. Dec 2018 — Feb 2019 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  10. Nov 2018 — Dec 2018 [monthly]

    Active Not Recruiting PHASE1_PHASE2

    Status: RecruitingActive Not Recruiting

  11. Sep 2018 — Nov 2018 [monthly]

    Recruiting PHASE1_PHASE2

  12. Jul 2018 — Sep 2018 [monthly]

    Recruiting PHASE1_PHASE2

  13. Jun 2018 — Jul 2018 [monthly]

    Recruiting PHASE1_PHASE2

  14. Mar 2018 — Jun 2018 [monthly]

    Recruiting PHASE1_PHASE2

  15. Dec 2017 — Mar 2018 [monthly]

    Recruiting PHASE1_PHASE2

  16. Jun 2017 — Dec 2017 [monthly]

    Recruiting PHASE1_PHASE2

  17. Feb 2017 — Jun 2017 [monthly]

    Recruiting PHASE1_PHASE2

  18. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE1_PHASE2

    First recorded

Dec 2014

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Novartis Pharmaceuticals
Data source: Novartis

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