deltatrials
Active Not Recruiting PHASE2 INTERVENTIONAL 1-arm NCT02365597

An Efficacy and Safety Study of Erdafitinib (JNJ-42756493) in Participants With Urothelial Cancer

A Phase 2, Two-arm Multicenter, Open-Label Study to Determine the Efficacy and the Safety of Two Different Dose Regimens of a Pan-FGFR Tyrosine Kinase Inhibitor JNJ-42756493 in Subjects With Metastatic or Surgically Unresectable Urothelial Cancer With FGFR Genomic Alterations

Sponsor: Janssen Research & Development, LLC

Conditions Urothelial Cancer
Interventions Erdafitinib Metformin Midazolam
Updated 74 times since 2017 Last updated: Jan 15, 2026 Started: Apr 22, 2015 Primary completion: Sep 15, 2022 Completion: Mar 31, 2027
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE2 clinical study on Urothelial Cancer, this trial is ongoing. The trial is conducted by Janssen Research & Development, LLC and has accumulated 74 data snapshots since 2015. 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 – ~May 2017 · 3 months · monthly snapshot~May 2017 – ~Jul 2017 · 2 months · monthly snapshot~Jul 2017 – ~Sep 2017 · 2 months · monthly snapshot~Sep 2017 – ~Oct 2017 · 30 days · monthly snapshot~Oct 2017 – ~Dec 2017 · 2 months · monthly snapshot~Dec 2017 – ~Jan 2018 · 31 days · monthly snapshot~Jan 2018 – ~Jun 2018 · 5 months · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Aug 2018 · 31 days · monthly snapshot~Aug 2018 – ~Sep 2018 · 31 days · monthly snapshot~Sep 2018 – ~Dec 2018 · 3 months · monthly snapshot~Dec 2018 – ~Mar 2019 · 3 months · monthly snapshot~Mar 2019 – ~Apr 2019 · 31 days · monthly snapshot~Apr 2019 – ~Jul 2019 · 3 months · monthly snapshot~Jul 2019 – ~Sep 2019 · 2 months · monthly snapshot~Sep 2019 – ~Oct 2019 · 30 days · monthly snapshot~Oct 2019 – ~Nov 2019 · 31 days · monthly snapshot~Nov 2019 – ~Jan 2020 · 2 months · monthly snapshot~Jan 2020 – ~Feb 2020 · 31 days · monthly snapshot~Feb 2020 – ~Apr 2020 · 2 months · monthly snapshot~Apr 2020 – ~Jul 2020 · 3 months · monthly snapshot~Jul 2020 – ~Aug 2020 · 31 days · monthly snapshot~Aug 2020 – ~Oct 2020 · 2 months · monthly snapshot~Oct 2020 – ~Nov 2020 · 31 days · monthly snapshot~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Mar 2021 · 28 days · monthly snapshot~Mar 2021 – ~Apr 2021 · 31 days · monthly snapshot~Apr 2021 – ~May 2021 · 30 days · monthly snapshot~May 2021 – ~Jun 2021 · 31 days · monthly snapshot~Jun 2021 – ~Sep 2021 · 3 months · monthly snapshot~Sep 2021 – ~Oct 2021 · 30 days · monthly snapshot~Oct 2021 – ~Nov 2021 · 31 days · monthly snapshot~Nov 2021 – ~Dec 2021 · 30 days · monthly snapshot~Dec 2021 – ~Jan 2022 · 31 days · monthly snapshot~Jan 2022 – ~Feb 2022 · 31 days · monthly snapshot~Feb 2022 – ~Mar 2022 · 28 days · monthly snapshot~Mar 2022 – ~Apr 2022 · 31 days · monthly snapshot~Apr 2022 – ~May 2022 · 30 days · monthly snapshot~May 2022 – ~Jun 2022 · 31 days · monthly snapshot~Jun 2022 – ~Jul 2022 · 30 days · monthly snapshot~Jul 2022 – ~Sep 2022 · 2 months · monthly snapshot~Sep 2022 – ~Nov 2022 · 2 months · monthly snapshot~Nov 2022 – ~Dec 2022 · 30 days · monthly snapshot~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshot~Jan 2023 – ~Feb 2023 · 31 days · monthly snapshot~Feb 2023 – ~Mar 2023 · 28 days · monthly snapshot~Mar 2023 – ~Apr 2023 · 31 days · monthly snapshot~Apr 2023 – ~May 2023 · 30 days · monthly snapshot~May 2023 – ~Jun 2023 · 31 days · monthly snapshot~Jun 2023 – ~Aug 2023 · 2 months · monthly snapshot~Aug 2023 – ~Sep 2023 · 31 days · monthly snapshot~Sep 2023 – ~Nov 2023 · 2 months · monthly snapshot~Nov 2023 – ~Jun 2024 · 7 months · monthly snapshot~Jun 2024 – ~Jul 2024 · 30 days · monthly snapshot~Jul 2024 – ~Aug 2024 · 31 days · monthly snapshot~Aug 2024 – ~Sep 2024 · 31 days · monthly snapshot~Sep 2024 – ~Oct 2024 · 30 days · monthly snapshot~Oct 2024 – ~Nov 2024 · 31 days · monthly snapshot~Nov 2024 – ~Jan 2025 · 2 months · monthly snapshot~Jan 2025 – ~Feb 2025 · 31 days · monthly snapshot~Feb 2025 – ~Mar 2025 · 28 days · monthly snapshot~Mar 2025 – ~May 2025 · 2 months · monthly snapshot~May 2025 – ~Jun 2025 · 31 days · monthly snapshot~Jun 2025 – ~Jul 2025 · 30 days · monthly snapshot~Jul 2025 – ~Aug 2025 · 31 days · monthly snapshot~Aug 2025 – ~Sep 2025 · 31 days · monthly snapshot~Sep 2025 – ~Oct 2025 · 30 days · monthly snapshot~Oct 2025 – ~Nov 2025 · 31 days · monthly snapshot~Nov 2025 – ~Dec 2025 · 30 days · monthly snapshot~Dec 2025 – ~Jan 2026 · 31 days · monthly snapshot~Jan 2026 – ~Feb 2026 · 31 days · monthly snapshot~Feb 2026 – present · 7 months · monthly snapshot

Change History

74 versions recorded

  1. Feb 2026 — Present [monthly]

    Active Not Recruiting PHASE2

  2. Jan 2026 — Feb 2026 [monthly]

    Active Not Recruiting PHASE2

  3. Dec 2025 — Jan 2026 [monthly]

    Active Not Recruiting PHASE2

  4. Nov 2025 — Dec 2025 [monthly]

    Active Not Recruiting PHASE2

  5. Oct 2025 — Nov 2025 [monthly]

    Active Not Recruiting PHASE2

▶ Show 69 earlier versions

  1. Sep 2025 — Oct 2025 [monthly]

    Active Not Recruiting PHASE2

  2. Aug 2025 — Sep 2025 [monthly]

    Active Not Recruiting PHASE2

  3. Jul 2025 — Aug 2025 [monthly]

    Active Not Recruiting PHASE2

  4. Jun 2025 — Jul 2025 [monthly]

    Active Not Recruiting PHASE2

  5. May 2025 — Jun 2025 [monthly]

    Active Not Recruiting PHASE2

  6. Mar 2025 — May 2025 [monthly]

    Active Not Recruiting PHASE2

  7. Feb 2025 — Mar 2025 [monthly]

    Active Not Recruiting PHASE2

  8. Jan 2025 — Feb 2025 [monthly]

    Active Not Recruiting PHASE2

  9. Nov 2024 — Jan 2025 [monthly]

    Active Not Recruiting PHASE2

  10. Oct 2024 — Nov 2024 [monthly]

    Active Not Recruiting PHASE2

  11. Sep 2024 — Oct 2024 [monthly]

    Active Not Recruiting PHASE2

  12. Aug 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE2

  13. Jul 2024 — Aug 2024 [monthly]

    Active Not Recruiting PHASE2

  14. Jun 2024 — Jul 2024 [monthly]

    Active Not Recruiting PHASE2

  15. Nov 2023 — Jun 2024 [monthly]

    Active Not Recruiting PHASE2

  16. Sep 2023 — Nov 2023 [monthly]

    Active Not Recruiting PHASE2

  17. Aug 2023 — Sep 2023 [monthly]

    Active Not Recruiting PHASE2

  18. Jun 2023 — Aug 2023 [monthly]

    Active Not Recruiting PHASE2

  19. May 2023 — Jun 2023 [monthly]

    Active Not Recruiting PHASE2

  20. Apr 2023 — May 2023 [monthly]

    Active Not Recruiting PHASE2

  21. Mar 2023 — Apr 2023 [monthly]

    Active Not Recruiting PHASE2

  22. Feb 2023 — Mar 2023 [monthly]

    Active Not Recruiting PHASE2

  23. Jan 2023 — Feb 2023 [monthly]

    Active Not Recruiting PHASE2

  24. Dec 2022 — Jan 2023 [monthly]

    Active Not Recruiting PHASE2

    Status: Recruiting → Active Not Recruiting

  25. Nov 2022 — Dec 2022 [monthly]

    Recruiting PHASE2

    Status: Active Not Recruiting → Recruiting

  26. Sep 2022 — Nov 2022 [monthly]

    Active Not Recruiting PHASE2

    Status: Recruiting → Active Not Recruiting

  27. Jul 2022 — Sep 2022 [monthly]

    Recruiting PHASE2

  28. Jun 2022 — Jul 2022 [monthly]

    Recruiting PHASE2

  29. May 2022 — Jun 2022 [monthly]

    Recruiting PHASE2

  30. Apr 2022 — May 2022 [monthly]

    Recruiting PHASE2

  31. Mar 2022 — Apr 2022 [monthly]

    Recruiting PHASE2

  32. Feb 2022 — Mar 2022 [monthly]

    Recruiting PHASE2

  33. Jan 2022 — Feb 2022 [monthly]

    Recruiting PHASE2

  34. Dec 2021 — Jan 2022 [monthly]

    Recruiting PHASE2

  35. Nov 2021 — Dec 2021 [monthly]

    Recruiting PHASE2

  36. Oct 2021 — Nov 2021 [monthly]

    Recruiting PHASE2

  37. Sep 2021 — Oct 2021 [monthly]

    Recruiting PHASE2

  38. Jun 2021 — Sep 2021 [monthly]

    Recruiting PHASE2

  39. May 2021 — Jun 2021 [monthly]

    Recruiting PHASE2

  40. Apr 2021 — May 2021 [monthly]

    Recruiting PHASE2

  41. Mar 2021 — Apr 2021 [monthly]

    Recruiting PHASE2

  42. Feb 2021 — Mar 2021 [monthly]

    Recruiting PHASE2

  43. Jan 2021 — Feb 2021 [monthly]

    Recruiting PHASE2

  44. Nov 2020 — Jan 2021 [monthly]

    Recruiting PHASE2

  45. Oct 2020 — Nov 2020 [monthly]

    Recruiting PHASE2

    Status: Active Not Recruiting → Recruiting

  46. Aug 2020 — Oct 2020 [monthly]

    Active Not Recruiting PHASE2

  47. Jul 2020 — Aug 2020 [monthly]

    Active Not Recruiting PHASE2

  48. Apr 2020 — Jul 2020 [monthly]

    Active Not Recruiting PHASE2

  49. Feb 2020 — Apr 2020 [monthly]

    Active Not Recruiting PHASE2

  50. Jan 2020 — Feb 2020 [monthly]

    Active Not Recruiting PHASE2

  51. Nov 2019 — Jan 2020 [monthly]

    Active Not Recruiting PHASE2

  52. Oct 2019 — Nov 2019 [monthly]

    Active Not Recruiting PHASE2

  53. Sep 2019 — Oct 2019 [monthly]

    Active Not Recruiting PHASE2

  54. Jul 2019 — Sep 2019 [monthly]

    Active Not Recruiting PHASE2

  55. Apr 2019 — Jul 2019 [monthly]

    Active Not Recruiting PHASE2

  56. Mar 2019 — Apr 2019 [monthly]

    Active Not Recruiting PHASE2

    Status: Enrolling By Invitation → Active Not Recruiting

  57. Dec 2018 — Mar 2019 [monthly]

    Enrolling By Invitation PHASE2

    Status: Recruiting → Enrolling By Invitation

  58. Sep 2018 — Dec 2018 [monthly]

    Recruiting PHASE2

  59. Aug 2018 — Sep 2018 [monthly]

    Recruiting PHASE2

  60. Jul 2018 — Aug 2018 [monthly]

    Recruiting PHASE2

  61. Jun 2018 — Jul 2018 [monthly]

    Recruiting PHASE2

  62. Jan 2018 — Jun 2018 [monthly]

    Recruiting PHASE2

  63. Dec 2017 — Jan 2018 [monthly]

    Recruiting PHASE2

  64. Oct 2017 — Dec 2017 [monthly]

    Recruiting PHASE2

  65. Sep 2017 — Oct 2017 [monthly]

    Recruiting PHASE2

  66. Jul 2017 — Sep 2017 [monthly]

    Recruiting PHASE2

  67. May 2017 — Jul 2017 [monthly]

    Recruiting PHASE2

  68. Feb 2017 — May 2017 [monthly]

    Recruiting PHASE2

  69. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE2

    First recorded

Apr 2015

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Janssen Research & Development, LLC
Data source: Janssen Research & Development, LLC

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

Study Locations

Aalst, Belgium , Angers, France , Aurora, United States , Badalona, Spain , Bangalore, India , Barcelona, Spain , Barnaul, Russia , Beer Yaakov, Israel , Beersheba, Israel , Berlin, Germany and 95 more locations