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Clinical trial · no report yet · Phase 3

PROOF 302

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

We haven't built a report for this trial yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.

Preliminary discovery

Commentary in our index that names this trial so far

Podcasts, YouTube videos and X posts we have indexed. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build.

ChannelFound
X threads20
YouTube6
Podcasts2

The trial

ClinicalTrials.gov
Official title
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)
Phase
Phase 3
Status
Terminated
Conditions
Upper Tract Urothelial Carcinomas; Urothelial Bladder Cancer
Interventions
Infigratinib; Placebo
Arms
  • Infigratinib 125 mg · Experimental
  • Placebo · Placebo comparator
Enrollment
39
Primary outcomes
  • Centrally Determined Disease-free Survival (DFS)
Sponsor
QED Therapeutics, a BridgeBio company with Helsinn Healthcare SA
Start
Mar 11, 2020
Primary completion
Feb 28, 2023
Results posted
Yes
Registry record
NCT04197986 · updated Mar 13, 2024

Publications

linked from the registry
  • Szymaniak J, Porten SP. Which Biomarkers are Useful in the Management of Muscle-invasive Bladder Cancer in 2022? Eur Urol Focus. 2022 Jul;8(4):901-903. doi: 10.1016/j.euf.2022.08.009. Epub 2022 Sep 2. PubMed 36058810
  • Pal SK, Somford DM, Grivas P, Sridhar SS, Gupta S, Bellmunt J, Sonpavde G, Fleming MT, Lerner SP, Loriot Y, Hoffman-Censits J, Valderrama BP, Andresen C, Schnabel MJ, Cole S, Daneshmand S. Targeting FGFR3 alterations with adjuvant infigratinib in invasive urothelial carcinoma: the phase III PROOF 302 trial. Future Oncol. 2022 Jul;18(21):2599-2614. doi: 10.2217/fon-2021-1629. Epub 2022 May 24. PubMed 35608106