{"preliminary_commentary":{"by_channel":{"x_thread":6},"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":[["derazantinib"]],"indication":"FGFR2 fusion-, mutation- or amplification-positive advanced intrahepatic cholangiocarcinoma","name":"FIDES-01","nct_id":"NCT03230318","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=fides-01-nct03230318. The price is an estimate of verified statements from the commentary indexed so far. Final coverage is set when the report is built. You never pay more than quoted: if the report is delivered at a smaller size, you pay that size's price, and anything paid above it is refunded. 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_rule":"Never more than quoted: the buyer pays the smaller of price_usd and the price the delivered edition is sold at.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"FIDES-01","arms":[{"description":"Oral administration","label":"derazantinib","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2022-10-25","type":"ACTUAL"},"conditions":["Intrahepatic Cholangiocarcinoma","Combined Hepatocellular and Cholangiocarcinoma"],"enrollment":{"count":148,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"derazantinib","otherNames":[],"type":"DRUG"}],"last_update":"2023-12-19","lead_sponsor":"Basilea Pharmaceutica","official_title":"A Pivotal Study of Derazantinib in Patients With Inoperable or Advanced Intrahepatic Cholangiocarcinoma and FGFR2 Gene Fusions or FGFR2 Gene Mutations or Amplifications","overall_status":"COMPLETED","phases":["PHASE2"],"primary_completion_date":{"date":"2022-10-25","type":"ACTUAL"},"primary_outcomes":[{"measure":"Substudy 1: Objective Response Rate (ORR)","timeFrame":"From first dose and up to 54 months"},{"measure":"Substudy 2: Progression Free Survival at 3 Months (PFS 3)","timeFrame":"From first dose and up to 3 months"}],"references":[{"citation":"Mazzaferro V, El-Rayes BF, Droz Dit Busset M, Cotsoglou C, Harris WP, Damjanov N, Masi G, Rimassa L, Personeni N, Braiteh F, Zagonel V, Papadopoulos KP, Hall T, Wang Y, Schwartz B, Kazakin J, Bhoori S, de Braud F, Shaib WL. Derazantinib (ARQ 087) in advanced or inoperable FGFR2 gene fusion-positive intrahepatic cholangiocarcinoma. Br J Cancer. 2019 Jan;120(2):165-171. doi: 10.1038/s41416-018-0334-0. Epub 2018 Nov 13.","pmid":"30420614","type":"DERIVED"}],"start_date":{"date":"2017-09-28","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Derazantinib in Subjects With FGFR2 Gene Fusion-, Mutation- or Amplification- Positive Inoperable or Advanced Intrahepatic Cholangiocarcinoma","url":"https://clinicaltrials.gov/study/NCT03230318"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.2","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/fides-01-nct03230318"}