{"preliminary_commentary":{"by_channel":{"x_thread":14,"youtube":10,"podcast":9},"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":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT02052778\", \"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."},"commentary_summary":null,"name":"FOENIX-CCA2","nct_id":"NCT02052778","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=foenix-cca2-nct02052778. 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":1950,"size":"deep","size_rule":"Deep: 301+ verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Participants with or without fibroblast growth factor \\[FGF\\]/fibroblast growth factor receptor \\[FGFR\\] gene abnormalities received orally TAS-120 8 milligrams (mg) orally every other day (QOD; Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.","label":"Phase 1: Dose Escalation: QOD Dosing: 8 mg","type":"EXPERIMENTAL"},{"description":"Participants with or without FGF/FGFR gene abnormalities received orally TAS-120 16 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.","label":"Phase 1: Dose Escalation: QOD Dosing: 16 mg","type":"EXPERIMENTAL"},{"description":"Participants with or without FGF/FGFR gene abnormalities received orally TAS-120 24 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.","label":"Phase 1: Dose Escalation: QOD Dosing: 24 mg","type":"EXPERIMENTAL"},{"description":"Participants with or without FGF/FGFR gene abnormalities received orally TAS-120 36 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.","label":"Phase 1: Dose Escalation: QOD Dosing: 36 mg","type":"EXPERIMENTAL"},{"description":"Participants with FGF/FGFR gene abnormalities received orally TAS-120 56 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.","label":"Phase 1: Dose Escalation: QOD Dosing: 56 mg","type":"EXPERIMENTAL"},{"description":"Participants with FGF/FGFR gene abnormalities received orally TAS-120 80 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.","label":"Phase 1: Dose Escalation: QOD Dosing: 80 mg","type":"EXPERIMENTAL"},{"description":"Participants with FGF/FGFR gene abnormalities received orally TAS-120 120 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.","label":"Phase 1: Dose Escalation: QOD Dosing: 120 mg","type":"EXPERIMENTAL"},{"description":"Participants with FGF/FGFR gene abnormalities received orally TAS-120 160 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.","label":"Phase 1: Dose Escalation: QOD Dosing: 160 mg","type":"EXPERIMENTAL"},{"description":"Participants with FGF/FGFR gene abnormalities received orally TAS-120 200 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.","label":"Phase 1: Dose Escalation: QOD Dosing: 200 mg","type":"EXPERIMENTAL"},{"description":"Participants with or without FGF/FGFR gene abnormalities received a dose between 4 mg orally once daily (QD) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.","label":"Phase 1: Dose Escalation: QD Dosing: 4 mg","type":"EXPERIMENTAL"},{"description":"Participants with or without FGF/FGFR gene abnormalities received a dose between 8 mg orally QD in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.","label":"Phase 1: Dose Escalation: QD Dosing: 8 mg","type":"EXPERIMENTAL"},{"description":"Participants with or without FGF/FGFR gene abnormalities received a dose between 16 mg orally QD in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.","label":"Phase 1: Dose Escalation: QD Dosing: 16 mg","type":"EXPERIMENTAL"},{"description":"Participants with or without FGF/FGFR gene abnormalities received a dose between 20 mg orally QD in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.","label":"Phase 1: Dose Escalation: QD Dosing: 20 mg","type":"EXPERIMENTAL"},{"description":"Participants with or without FGF/FGFR gene abnormalities received a dose between 24 mg orally QD in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.","label":"Phase 1: Dose Escalation: QD Dosing: 24 mg","type":"EXPERIMENTAL"},{"description":"Participants with intra-hepatic or extrahepatic cholangiocarcinoma (iCCA or eCCA) harboring FGFR2 gene fusions or rearrangements and who were treated or not treated with prior FGFR inhibitors received TAS-120 20 mg tablets orally QD in each of 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.","label":"Phase 1: Dose Expansion Cohort 1","type":"EXPERIMENTAL"},{"description":"Participants with primary central nervous system (CNS) tumors harboring FGFR gene fusions or FGFR1 activating mutations received TAS-120 20 mg tablets orally QD in each of 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.","label":"Phase 1: Dose Expansion: Cohort 2","type":"EXPERIMENTAL"},{"description":"Participants with advanced urothelial carcinoma harboring FGFR3 gene fusions or FGFR3 activating mutations received TAS-120 20 mg tablets orally QD in each of 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.","label":"Phase 1: Dose Expansion: Cohort 3","type":"EXPERIMENTAL"},{"description":"Participants with breast or gastric cancer with harboring FGFR2 amplification received TAS-120 20 mg tablets orally QD in each of 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.","label":"Phase 1: Dose Expansion: Cohort 4","type":"EXPERIMENTAL"},{"description":"Participants with tumor types harboring FGFR gene fusions or activating mutations received TAS-120 20 mg tablets orally QD in each of 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.","label":"Phase 1:Dose Expansion: Cohort 5","type":"EXPERIMENTAL"},{"description":"Participants who were not included in Cohorts 1 to 5 received TAS-120 20 mg tablets orally QD in each of 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.","label":"Phase 1: Dose Expansion: Cohort 6","type":"EXPERIMENTAL"},{"description":"Participants with iCCA who were enrolled prior to the confirmation of the recommended Phase 2 dose (RP2D) received TAS-120 16 mg tablets orally QD in each of 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.","label":"Phase 1: Dose Expansion: Sub-cohort 1","type":"EXPERIMENTAL"},{"description":"Participants with other tumor types who were enrolled prior to the confirmation of the RP2D received TAS-120 16 mg tablets orally QD in each of 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.","label":"Phase 1: Dose Expansion: Sub-cohort 2","type":"EXPERIMENTAL"},{"description":"Participants with iCCA with tumors harboring FGFR2 gene rearrangements received TAS-120 20 mg tablets orally QD in each of 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.","label":"Phase 2","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2024-10-22","type":"ACTUAL"},"conditions":["Cholangiocarcinoma","Urothelial Cancer","Advanced and Metastatic Cancer Patients With Tumors Harboring FGF/FGFR Tumors","Primary CNS Tumors","Breast Cancer","Gastric Cancer"],"enrollment":{"count":407,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Futibatinib","otherNames":["TAS-120"],"type":"DRUG"}],"last_update":"2025-03-27","lead_sponsor":"Taiho Oncology, Inc.","official_title":"Phase 1/2 Study of TAS-120 in Patients With Advanced Solid Tumors Harboring FGF/FGFR Aberrations","overall_status":"COMPLETED","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2020-10-01","type":"ACTUAL"},"primary_outcomes":[{"measure":"Phase 1: Dose Escalation-Maximum Tolerated Dose (MTD)","timeFrame":"Cycle 1 (21-day cycle)"},{"measure":"Phase 1: Dose Escalation-Recommended Phase 2 Dose (RP2D) of 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Plain language summary of the FOENIX-CCA2 study: futibatinib for people with advanced bile duct cancer. Future Oncol. 2024;20(36):2811-2822. doi: 10.1080/14796694.2024.2364504. Epub 2024 Jun 17.","pmid":"38884254","type":"DERIVED"},{"citation":"DiPeri TP, Zhao M, Evans KW, Varadarajan K, Moss T, Scott S, Kahle MP, Byrnes CC, Chen H, Lee SS, Halim AB, Hirai H, Wacheck V, Kwong LN, Rodon J, Javle M, Meric-Bernstam F. Convergent MAPK pathway alterations mediate acquired resistance to FGFR inhibitors in FGFR2 fusion-positive cholangiocarcinoma. J Hepatol. 2024 Feb;80(2):322-334. doi: 10.1016/j.jhep.2023.10.041. Epub 2023 Nov 14.","pmid":"37972659","type":"DERIVED"},{"citation":"Goyal L, Meric-Bernstam F, Hollebecque A, Valle JW, Morizane C, Karasic TB, Abrams TA, Furuse J, Kelley RK, Cassier PA, Klumpen HJ, Chang HM, Chen LT, Tabernero J, Oh DY, Mahipal A, Moehler M, Mitchell EP, Komatsu Y, Masuda K, Ahn D, Epstein RS, Halim AB, Fu Y, Salimi T, Wacheck V, He Y, Liu M, Benhadji KA, Bridgewater JA; FOENIX-CCA2 Study Investigators. Futibatinib for FGFR2-Rearranged Intrahepatic Cholangiocarcinoma. N Engl J Med. 2023 Jan 19;388(3):228-239. doi: 10.1056/NEJMoa2206834.","pmid":"36652354","type":"DERIVED"},{"citation":"Bahleda R, Meric-Bernstam F, Goyal L, Tran B, He Y, Yamamiya I, Benhadji KA, Matos I, Arkenau HT. Phase I, first-in-human study of futibatinib, a highly selective, irreversible FGFR1-4 inhibitor in patients with advanced solid tumors. Ann Oncol. 2020 Oct;31(10):1405-1412. doi: 10.1016/j.annonc.2020.06.018. Epub 2020 Jul 2.","pmid":"32622884","type":"DERIVED"}],"start_date":{"date":"2014-07-21","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of TAS-120 in Patients With Advanced Solid Tumors","url":"https://clinicaltrials.gov/study/NCT02052778"},"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/foenix-cca2-nct02052778"}