{"preliminary_commentary":{"by_channel":{"x_thread":20,"youtube":6,"podcast":2},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build."},"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 free public preview; the full report is still bought."},"name":"PROOF 302","nct_id":"NCT04197986","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=proof-302-nct04197986. The price is an estimate of verified HCP statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":1950,"size":"deep","size_rule":"Deep: 301+ verified HCP statements, estimated at 14 per indexed commentary source"},"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","otherNames":["IP","Study drug"],"type":"DRUG"},{"name":"Placebo","otherNames":[],"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":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/proof-302-nct04197986"}