NCT04197986

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

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: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: QED Therapeutics, a BridgeBio company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Upper Tract Urothelial Carcinomas
• Urothelial Bladder Cancer

Interventions

Type	Name	Description
DRUG	Infigratinib	Participants randomly assigned to infigratinib will receive hard gelatin capsules for oral administration of infigratinib 125 mg once a day (administered as one 100-mg capsule and one 25-mg capsule) using a 3 weeks on (Days 1-21) /1 week off (Days 22-28) dosing schedule.
DRUG	Placebo	Participants randomly assigned to placebo will receive placebo matching in appearance the investigational product (infigratinib), which will be provided as hard gelatin capsules for oral use and will be administered once daily on a 3 weeks on (Days 1-21) /1 week off (Days 22-28) dosing schedule.

Timeline

• Start date: 2020-03-11
• Primary completion: 2023-02-28
• Completion: 2023-02-28
• First posted: 2019-12-13
• Last updated: 2024-03-13
• Results posted: 2024-03-13

Locations

143 sites across 11 countries: United States, Belgium, Bulgaria, Canada, France, Germany, Greece, Italy, Netherlands, Spain, United Kingdom

Regulatory

• FDA-regulated drug study