Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial of Infigratinib for the Adjuvant Treatment of Subjects With Invasive Urothelial Carcinoma With Susceptible FGFR3 Genetic Alterations (PROOF 302)

  • STATUS
    Recruiting
  • End date
    Jan 31, 2025
  • participants needed
    218
  • sponsor
    QED Therapeutics, Inc.
Updated on 22 September 2022

Summary

This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study to evaluate the efficacy of infigratinib (an oral targeted FGFR1-3 inhibitor) versus placebo, as adjuvant treatment following surgery in adult subjects with invasive urothelial carcinoma and susceptible FGFR3 genetic alterations (mutations, and gene fusions or rearrangements) who have disease that is considered at high risk for recurrence with surgery alone. The study enrolls subjects with either bladder cancer post radical cystectomy or upper tract urothelial cancer post distal ureterectomy and/or nephrectomy. Study treatment is randomized 1:1 between infigratinib or placebo with treatment up to 1 year or until invasive local, distal, or metastatic disease recurrence confirmed by independent imaging reviewer.

Details
Condition Upper Tract Urothelial Carcinomas, Urothelial Bladder Cancer
Treatment Placebo, Infigratinib
Clinical Study IdentifierNCT04197986
SponsorQED Therapeutics, Inc.
Last Modified on22 September 2022

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