{"preliminary_commentary":{"by_channel":{"x_thread":3},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":false},"commentary_summary":null,"name":"CBGJ398X2204","nct_id":"NCT02150967","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=cbgj398x2204-nct02150967. 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":null,"arms":[{"description":"To estimate the anti-tumor activity of BGJ398 (infigratinib)","label":"BGJ398 (infigratinib)","type":"EXPERIMENTAL"}],"collaborators":["Helsinn Healthcare SA"],"completion_date":{"date":"2022-02-07","type":"ACTUAL"},"conditions":["Advanced Cholangiocarcinoma","FGFR2 Gene Mutation"],"enrollment":{"count":143,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"BGJ398 (infigratinib)","otherNames":[],"type":"DRUG"}],"last_update":"2023-07-03","lead_sponsor":"QED Therapeutics, a BridgeBio company","official_title":"A Phase II Multicenter, Single Arm Study of Oral BGJ398 in Adult Patients With Advanced or Metastatic Cholangiocarcinoma With FGFR2 Gene Fusions or Other FGFR Genetic Alterations Who Failed or Are Intolerant to Platinum-based Chemotherapy","overall_status":"TERMINATED","phases":["PHASE2"],"primary_completion_date":{"date":"2021-03-01","type":"ACTUAL"},"primary_outcomes":[{"measure":"Overall Response Rate (ORR) as Assessed by Blinded Independent Central Imaging Review (BICR)","timeFrame":"Analysis was conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021."}],"references":[{"citation":"Javle M, Roychowdhury S, Kelley RK, Sadeghi S, Macarulla T, Weiss KH, Waldschmidt DT, Goyal L, Borbath I, El-Khoueiry A, Borad MJ, Yong WP, Philip PA, Bitzer M, Tanasanvimon S, Li A, Pande A, Soifer HS, Shepherd SP, Moran S, Zhu AX, Bekaii-Saab TS, Abou-Alfa GK. Infigratinib (BGJ398) in previously treated patients with advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements: mature results from a multicentre, open-label, single-arm, phase 2 study. Lancet Gastroenterol Hepatol. 2021 Oct;6(10):803-815. doi: 10.1016/S2468-1253(21)00196-5. Epub 2021 Aug 3.","pmid":"34358484","type":"DERIVED"},{"citation":"Javle M, Lowery M, Shroff RT, Weiss KH, Springfeld C, Borad MJ, Ramanathan RK, Goyal L, Sadeghi S, Macarulla T, El-Khoueiry A, Kelley RK, Borbath I, Choo SP, Oh DY, Philip PA, Chen LT, Reungwetwattana T, Van Cutsem E, Yeh KH, Ciombor K, Finn RS, Patel A, Sen S, Porter D, Isaacs R, Zhu AX, Abou-Alfa GK, Bekaii-Saab T. Phase II Study of BGJ398 in Patients With FGFR-Altered Advanced Cholangiocarcinoma. J Clin Oncol. 2018 Jan 20;36(3):276-282. doi: 10.1200/JCO.2017.75.5009. Epub 2017 Nov 28.","pmid":"29182496","type":"DERIVED"},{"citation":"Borad MJ, Gores GJ, Roberts LR. Fibroblast growth factor receptor 2 fusions as a target for treating cholangiocarcinoma. Curr Opin Gastroenterol. 2015 May;31(3):264-8. doi: 10.1097/MOG.0000000000000171.","pmid":"25763789","type":"DERIVED"}],"start_date":{"date":"2014-07-23","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Phase II, Single Arm Study of BGJ398 in Patients With Advanced Cholangiocarcinoma","url":"https://clinicaltrials.gov/study/NCT02150967"},"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/cbgj398x2204-nct02150967"}