Phase 3 Multicenter, Double-Blind, randomized, placebo-controlled trail of Infigratinib for the Adjuvant Treatment of Subjects with Invasive Urothelial Carcinoma with Susceptible FGFR3 Genetic Alterations (PROOF 302)

Investigator: Raj Satkunasivam, MD

Study Coordinator:

Status: Enrolling

ClinicalTrials.gov Number: NCT04197986

Phone:

Protocol Number: PRO00023986

Description

This is a Phase 3, Multicenter, Double-blind, Randomized, Placebo-Controlled Trial to evaluate the efficacy of Infigratinib in adult patients with invasive urothelial carcinoma with susceptible FGFR3 genetic alterations (mutations, and gene fusions or translocations)who are within 120 days following nephrouretectomy,distal uretectomy, or cystectomy and ineligible for cisplatin-based (neo) adjuvant chemotherapy or with residual disease after neoadjuvant therapy. NCT: NCT04197986
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