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

Trial Profile

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

Recruiting
Phase of Trial: Phase II

Latest Information Update: 15 Mar 2018

At a glance

  • Drugs Erdafitinib (Primary)
  • Indications Urogenital cancer
  • Focus Therapeutic Use
  • Sponsors Janssen Research & Development; Janssen-Cilag
  • Most Recent Events

    • 15 Mar 2018 According to a Johnson & Johnson media release, based on the data from this study, U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for erdafitinib in the treatment of urothelial cancer.
    • 10 Feb 2018 Results of a subgroup analysis presented at the 2018 Genitourinary Cancers Symposium.
    • 10 Feb 2018 Results (n=78) assessing efficacy and safety presented at the 2018 Genitourinary Cancers Symposium
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