{"commentary":{"count":26,"free_build_floor":8,"listing_floor":3,"by_channel":{"x_thread":18,"youtube":6,"podcast":2},"note":"Indexed podcasts, YouTube videos and X posts that name this trial. A report screens them, searches for more and cites what clinicians said when it is built."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT04197986\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's public preview; the full report is still bought."},"name":"PROOF302","nct_id":"NCT04197986","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=proof302-nct04197986. The price is fixed at order. We build the report after the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":1250,"size":"standard","size_rule":"Standard: 13–40 commentary sources"},"registry":{"acronym":"PROOF302","arms":[{"description":"Participants will be randomly assigned (1:1) to receive oral infigratinib administered once daily for the first 3 weeks (21 days) of each 28-day cycle for a maximum of 52 weeks","label":"Infigratinib 125 mg","type":"EXPERIMENTAL"},{"description":"Participants will be randomly assigned (1:1) to receive oral placebo administered once daily for the first 3 weeks (21 days) of each 28-day cycle for a maximum of 52 weeks","label":"Placebo","type":"PLACEBO_COMPARATOR"}],"collaborators":["Helsinn Healthcare SA"],"completion_date":{"date":"2023-02-28","type":"ACTUAL"},"conditions":["Upper Tract Urothelial Carcinomas","Urothelial Bladder Cancer"],"enrollment":{"count":39,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Infigratinib","type":"DRUG"},{"name":"Placebo","type":"DRUG"}],"last_update":"2024-03-13","lead_sponsor":"QED Therapeutics, a BridgeBio company","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)","overall_status":"TERMINATED","phases":["PHASE3"],"primary_completion_date":{"date":"2023-02-28","type":"ACTUAL"},"primary_outcomes":[{"measure":"Centrally Determined Disease-free Survival (DFS)","timeFrame":"The number of months from date of randomization to local/regional invasive or metastatic recurrence or death due to any cause."}],"references":[{"citation":"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.","pmid":"36058810","type":"DERIVED"},{"citation":"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.","pmid":"35608106","type":"DERIVED"}],"start_date":{"date":"2020-03-11","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Oral Infigratinib for the Adjuvant Treatment of Subjects With Invasive Urothelial Carcinoma With Susceptible FGFR3 Genetic Alterations","url":"https://clinicaltrials.gov/study/NCT04197986"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"2.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/proof302-nct04197986"}