{"preliminary_commentary":{"by_channel":{"x_thread":7},"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,"drugs_tested":[["infigratinib"]],"indication":"first-line advanced cholangiocarcinoma with FGFR2 gene fusions/translocations","name":"PROOF 301","nct_id":"NCT03773302","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=proof-301-nct03773302. 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":"Infigratinib (BGJ398) 125 mg orally daily, 3 weeks on, 1 week off.","label":"Infigratinib (BGJ398) 125 mg","type":"EXPERIMENTAL"},{"description":"Participants who experience disease progression while receiving gemcitabine + cisplatin will be allowed to cross over and receive infigratinib if certain criteria are met.","label":"Gemcitabine + Cisplatin","type":"ACTIVE_COMPARATOR"}],"collaborators":["Helsinn Healthcare SA"],"completion_date":{"date":"2023-03-02","type":"ACTUAL"},"conditions":["Advanced Cholangiocarcinoma","FGFR2 Gene Mutation"],"enrollment":{"count":48,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"BGJ398","otherNames":["Infigratinib"],"type":"DRUG"},{"name":"Gemcitabine","otherNames":[],"type":"DRUG"},{"name":"Cisplatin","otherNames":[],"type":"DRUG"}],"last_update":"2024-05-08","lead_sponsor":"QED Therapeutics, a BridgeBio company","official_title":"A Phase 3 Multicenter, Open-Label, Randomized, Controlled Study of Oral Infigratinib Versus Gemcitabine With Cisplatin in Subjects With Advanced/Metastatic or Inoperable Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations: The PROOF Trial","overall_status":"TERMINATED","phases":["PHASE3"],"primary_completion_date":{"date":"2023-03-02","type":"ACTUAL"},"primary_outcomes":[{"measure":"Progression-free Survival (Central Imaging Assessment)","timeFrame":"From the time of randomization to end of treatment due to confirmed disease progression or death. Note: PFS is an event driven endpoint. Subjects without confirmed disease progression at the end of study were censored at their last valid tumor assessment."}],"references":[{"citation":"Makawita S, K Abou-Alfa G, Roychowdhury S, Sadeghi S, Borbath I, Goyal L, Cohn A, Lamarca A, Oh DY, Macarulla T, T Shroff R, Howland M, Li A, Cho T, Pande A, Javle M. Infigratinib in patients with advanced cholangiocarcinoma with FGFR2 gene fusions/translocations: the PROOF 301 trial. Future Oncol. 2020 Oct;16(30):2375-2384. doi: 10.2217/fon-2020-0299. Epub 2020 Jun 25.","pmid":"32580579","type":"DERIVED"}],"start_date":{"date":"2019-12-27","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations","url":"https://clinicaltrials.gov/study/NCT03773302"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.1","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/proof-301-nct03773302"}