{"preliminary_commentary":{"by_channel":{"youtube":20,"x_thread":15,"podcast":14,"bluesky_thread":1},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT03785964\", \"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."},"name":"DeFi","nct_id":"NCT03785964","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=defi-nct03785964. 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":"DeFi","arms":[{"description":"Nirogacestat 150 mg by mouth, twice daily","label":"Double-Blind Phase - Nirogacestat","type":"EXPERIMENTAL"},{"description":"Placebo by mouth, twice daily","label":"Double-Blind Phase - Placebo","type":"PLACEBO_COMPARATOR"},{"description":"Nirogacestat 150 mg by mouth, twice daily","label":"Open-Label Phase - Nirogacestat","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2024-10-17","type":"ACTUAL"},"conditions":["Desmoid Tumor","Aggressive Fibromatosis"],"enrollment":{"count":142,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Nirogacestat oral tablet","otherNames":["PF-03084014"],"type":"DRUG"},{"name":"Placebo Oral Tablet","otherNames":[],"type":"DRUG"}],"last_update":"2026-08-20","lead_sponsor":"SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany","official_title":"A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Nirogacestat Versus Placebo in Adult Patients With Progressing Desmoid Tumors/Aggressive Fibromatosis (DT/AF)","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2022-04-07","type":"ACTUAL"},"primary_outcomes":[{"measure":"Progression Free Survival (PFS) Defined as the Time From Randomization Until Date of Assessment of Progression or Death by Any Cause.","timeFrame":"On the first day of every 3 cycles (each cycle is 28 days) until disease progression is observed or death, whichever comes first, assessed up to approximately 2 years"}],"references":[{"citation":"Ratan R, Kasper B, Alcindor T, Schoffski P, van der Graaf WTA, Federman N, Bui NQ, D'Amato G, Riedel RF, Attia S, Chawla S, Lim A, Tumminello B, Oton AB, Chu Y, Zhou S, Gounder M. Efficacy and Safety of Long-Term Continuous Nirogacestat Treatment in Adults With Desmoid Tumors: Results From the DeFi Trial. J Clin Oncol. 2025 Dec;43(34):3646-3651. doi: 10.1200/JCO-25-00582. Epub 2025 Oct 20.","pmid":"41115259","type":"DERIVED"},{"citation":"Gounder MM, Atkinson TM, Bell T, Daskalopoulou C, Griffiths P, Martindale M, Smith LM, Lim A. GOunder/Desmoid Tumor Research Foundation DEsmoid Symptom/Impact Scale (GODDESS(c)): psychometric properties and clinically meaningful thresholds as assessed in the Phase 3 DeFi randomized controlled clinical trial. Qual Life Res. 2023 Oct;32(10):2861-2873. doi: 10.1007/s11136-023-03445-7. Epub 2023 Jun 22.","pmid":"37347393","type":"DERIVED"},{"citation":"Gounder M, Ratan R, Alcindor T, Schoffski P, van der Graaf WT, Wilky BA, Riedel RF, Lim A, Smith LM, Moody S, Attia S, Chawla S, D'Amato G, Federman N, Merriam P, Van Tine BA, Vincenzi B, Benson C, Bui NQ, Chugh R, Tinoco G, Charlson J, Dileo P, Hartner L, Lapeire L, Mazzeo F, Palmerini E, Reichardt P, Stacchiotti S, Bailey HH, Burgess MA, Cote GM, Davis LE, Deshpande H, Gelderblom H, Grignani G, Loggers E, Philip T, Pressey JG, Kummar S, Kasper B. Nirogacestat, a gamma-Secretase Inhibitor for Desmoid Tumors. N Engl J Med. 2023 Mar 9;388(10):898-912. doi: 10.1056/NEJMoa2210140.","pmid":"36884323","type":"DERIVED"}],"start_date":{"date":"2019-04-17","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Nirogacestat for Adults With Desmoid Tumor/Aggressive Fibromatosis (DT/AF)","url":"https://clinicaltrials.gov/study/NCT03785964"},"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/defi-nct03785964"}