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

Active:	No
Cancer Type:	Bladder Cancer Unknown Primary	NCT ID:	NCT04197986
Trial Phases:	Phase III	Protocol IDs:	QBGJ398-302 (primary) NCI-2020-00610 2019-003248-63
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	QED Therapeutics, Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT04197986

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.

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