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A Randomized Phase 2 Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Subjects Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) and FGFR Mutations or Fusions

Trial Profile

A Randomized Phase 2 Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Subjects Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) and FGFR Mutations or Fusions

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 14 Apr 2025

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At a glance

  • Drugs Erdafitinib (Primary) ; Gemcitabine; Metformin; Midazolam; Mitomycin
  • Indications Bladder cancer; Neuroendocrine carcinoma; Squamous cell cancer
  • Focus Therapeutic Use
  • Acronyms THOR-2
  • Sponsors Janssen Research & Development; Janssen-Cilag

Most Recent Events

  • 09 Apr 2025 Status changed from active, no longer recruiting to completed.
  • 31 Jan 2025 Planned End Date changed from 1 Mar 2025 to 3 Mar 2025.
  • 21 May 2024 Planned primary completion date changed from 29 Mar 2024 to 12 Jul 2024.

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