Study of Oral Infigratinib for the Adjuvant Treatment of Subjects With Invasive Urothelial Carcinoma With Susceptible FGFR3 Genetic Alterations

Official Title

Phase 3, Multicentre, 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)

Summary:

This is a Phase 3 multicentre, double-blind, randomized, placebo-controlled study to evaluate the efficacy of giving an oral targeted FGFR1-3 inhibitor, infigratinib, as adjuvant treatment following surgery in adult subjects with invasive urothelial carcinoma and susceptible FGFR3 genetic alterations (mutations, and gene fusions or translocations [ie, 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 between infigratinib or placebo with treatment until invasive local or distal disease recurrence.

Trial Description

Primary Outcome:

• Centrally determine disease-free survival (DFS)

• Compare DFS including intraluminal low-risk recurrence
• Compare metastasis-free survival (MFS)
• Compare overall survival (OS)
• Compare investigator-reviewed DFS
• Number of participants with adverse events (AEs) and serious adverse events (SAEs) as a measure of safety and tolerability

View this trial on ClinicalTrials.gov