{"preliminary_commentary":{"by_channel":{"x_thread":3,"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":false},"name":"FORT-1","nct_id":"NCT03410693","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=fort-1-nct03410693. The price is an estimate of verified 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":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"FORT-1","arms":[{"description":"Rogaratinib treatment study arm, comprising\n\n1. Pre-treatment period, including FGFR testing and screening,\n2. Treatment period, and\n3. Follow-up period, including active follow-up and long-term follow-up. Patients will be considered \"on study\" during the pre-treatment, treatment and active followup periods. During the long-term follow-up period the patients will be considered \"off study\".","label":"Rogaratinib","type":"EXPERIMENTAL"},{"description":"Chemotherapy treatment study arm, comprising\n\n1. Pre-treatment period, including FGFR testing and screening,\n2. Treatment period, and\n3. Follow-up period, including active follow-up and long-term follow-up. Patients will be considered \"on study\" during the pre-treatment, treatment and active followup periods. During the long-term follow-up period the patients will be considered \"off study\".","label":"Chemotherapy","type":"ACTIVE_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2020-10-27","type":"ACTUAL"},"conditions":["Carcinoma, Transitional Cell"],"enrollment":{"count":175,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Rogaratinib (BAY1163877)","otherNames":[],"type":"DRUG"},{"name":"Chemotherapy","otherNames":[],"type":"DRUG"}],"last_update":"2022-09-28","lead_sponsor":"Bayer","official_title":"A Randomized, Open Label, Multicenter Phase 2/3 Study to Evaluate the Efficacy and Safety of Rogaratinib (BAY1163877) Compared to Chemotherapy in Patients With FGFR-positive Locally Advanced or Metastatic Urothelial Carcinoma Who Have Received Prior Platinum-containing Chemotherapy","overall_status":"COMPLETED","phases":["PHASE2","PHASE3"],"primary_completion_date":{"date":"2020-10-27","type":"ACTUAL"},"primary_outcomes":[{"measure":"Objective Response Rate (ORR) - Central Assessment","timeFrame":"From start of treatment up to end of active follow-up, approximately 29 months"}],"references":[{"citation":"Sternberg CN, Petrylak DP, Bellmunt J, Nishiyama H, Necchi A, Gurney H, Lee JL, van der Heijden MS, Rosenbaum E, Penel N, Pang ST, Li JR, Garcia Del Muro X, Joly F, Papai Z, Bao W, Ellinghaus P, Lu C, Sierecki M, Coppieters S, Nakajima K, Ishida TC, Quinn DI. FORT-1: Phase II/III Study of Rogaratinib Versus Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma Selected Based on FGFR1/3 mRNA Expression. J Clin Oncol. 2023 Jan 20;41(3):629-639. doi: 10.1200/JCO.21.02303. Epub 2022 Oct 14.","pmid":"36240478","type":"DERIVED"},{"citation":"Grunewald S, Politz O, Bender S, Heroult M, Lustig K, Thuss U, Kneip C, Kopitz C, Zopf D, Collin MP, Boemer U, Ince S, Ellinghaus P, Mumberg D, Hess-Stumpp H, Ziegelbauer K. Rogaratinib: A potent and selective pan-FGFR inhibitor with broad antitumor activity in FGFR-overexpressing preclinical cancer models. Int J Cancer. 2019 Sep 1;145(5):1346-1357. doi: 10.1002/ijc.32224. Epub 2019 Mar 13.","pmid":"30807645","type":"DERIVED"}],"start_date":{"date":"2018-05-31","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Study of Rogaratinib (BAY1163877) vs Chemotherapy in Patients With FGFR (Fibroblast Growth Factor Receptor)-Positive Locally Advanced or Metastatic Urothelial Carcinoma","url":"https://clinicaltrials.gov/study/NCT03410693"},"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/fort-1-nct03410693"}