{"preliminary_commentary":{"by_channel":{"x_thread":31,"podcast":4,"youtube":2},"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\": \"NCT02989857\", \"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,"drugs_tested":[["ivosidenib"]],"indication":"previously treated advanced IDH1-mutant cholangiocarcinoma","name":"ClarIDHy","nct_id":"NCT02989857","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=claridhy-nct02989857. 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":"ClarIDHy","arms":[{"description":"Participants received AG-120 500 mg, tablet, orally, once a day (QD) in each 28-day treatment cycle, until occurrence of disease progression, unacceptable toxicity, confirmed pregnancy, death, subject withdrawal, lost to follow-up, or the sponsor ended the study for up to approximately 45 months.","label":"AG-120","type":"ACTIVE_COMPARATOR"},{"description":"Participants received AG-120 matched placebo, orally, QD in each 28-day treatment cycle, until occurrence of disease progression, unacceptable toxicity, confirmed pregnancy, death, subject withdrawal, lost to follow-up or the sponsor ended the study for up to approximately 7 months. Participants who experienced disease progression and received placebo were allowed to cross over and receive AG-120.","label":"Placebo","type":"PLACEBO_COMPARATOR"},{"description":"Participants who experienced disease progression and received placebo were allowed to cross over to receive AG-120 500 mg, tablet, orally, QD in each 28-day treatment cycle for up to approximately 32 months.","label":"After Cross over to AG-120","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2021-05-17","type":"ACTUAL"},"conditions":["Advanced Cholangiocarcinoma","Metastatic Cholangiocarcinoma"],"enrollment":{"count":187,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"AG-120","otherNames":["Ivosidenib"],"type":"DRUG"},{"name":"Placebo","otherNames":[],"type":"DRUG"}],"last_update":"2024-08-20","lead_sponsor":"Institut de Recherches Internationales Servier","official_title":"A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-controlled Study of AG-120 in Previously-treated Subjects With Nonresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2019-01-31","type":"ACTUAL"},"primary_outcomes":[{"measure":"Progression Free Survival (PFS) as Determined by the Independent Radiology Committee (IRC)","timeFrame":"From the date of randomization to the date of first documentation of disease progression or death due to any cause (Up to approximately 2 years)"}],"references":[{"citation":"Abou-Alfa GK, Macarulla T, Javle MM, Kelley RK, Lubner SJ, Adeva J, Cleary JM, Catenacci DV, Borad MJ, Bridgewater J, Harris WP, Murphy AG, Oh DY, Whisenant J, Lowery MA, Goyal L, Shroff RT, El-Khoueiry AB, Fan B, Wu B, Chamberlain CX, Jiang L, Gliser C, Pandya SS, Valle JW, Zhu AX. Ivosidenib in IDH1-mutant, chemotherapy-refractory cholangiocarcinoma (ClarIDHy): a multicentre, randomised, double-blind, placebo-controlled, phase 3 study. Lancet Oncol. 2020 Jun;21(6):796-807. doi: 10.1016/S1470-2045(20)30157-1. Epub 2020 May 13.","pmid":"32416072","type":"BACKGROUND"},{"citation":"Valle JW, Abou-Alfa GK, Kelley RK, Lowery MA, Shroff RT, Bian Y, Saint-Hilary G, Liu H, Teng Z, Hua Z, Gliser C, Vogel A, Javle MM. Quantitative benefit-risk assessment of data from the phase III ClarIDHy study of ivosidenib versus placebo in patients with mIDH1 cholangiocarcinoma. ESMO Gastrointest Oncol. 2025 Apr 3;8:100159. doi: 10.1016/j.esmogo.2025.100159. eCollection 2025 Jun.","pmid":"41646284","type":"DERIVED"},{"citation":"Fan B, Abou-Alfa GK, Zhu AX, Pandya SS, Jia H, Yin F, Gliser C, Hua Z, Hossain M, Yang H. Pharmacokinetics/pharmacodynamics of ivosidenib in advanced IDH1-mutant cholangiocarcinoma: findings from the phase III ClarIDHy study. Cancer Chemother Pharmacol. 2024 May;93(5):471-479. doi: 10.1007/s00280-023-04633-5. Epub 2024 Jan 27.","pmid":"38278871","type":"DERIVED"},{"citation":"Zhu AX, Macarulla T, Javle MM, Kelley RK, Lubner SJ, Adeva J, Cleary JM, Catenacci DVT, Borad MJ, Bridgewater JA, Harris WP, Murphy AG, Oh DY, Whisenant JR, Lowery MA, Goyal L, Shroff RT, El-Khoueiry AB, Chamberlain CX, Aguado-Fraile E, Choe S, Wu B, Liu H, Gliser C, Pandya SS, Valle JW, Abou-Alfa GK. Final Overall Survival Efficacy Results of Ivosidenib for Patients With Advanced Cholangiocarcinoma With IDH1 Mutation: The Phase 3 Randomized Clinical ClarIDHy Trial. JAMA Oncol. 2021 Nov 1;7(11):1669-1677. doi: 10.1001/jamaoncol.2021.3836.","pmid":"34554208","type":"DERIVED"}],"start_date":{"date":"2017-02-20","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Study of AG-120 in Previously Treated Advanced Cholangiocarcinoma With IDH1 Mutations (ClarIDHy)","url":"https://clinicaltrials.gov/study/NCT02989857"},"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/claridhy-nct02989857"}