{"preliminary_commentary":{"by_channel":{"x_thread":8},"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\": \"NCT03665441\", \"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":"Trybeca-1","nct_id":"NCT03665441","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=trybeca-1-nct03665441. 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":"Trybeca-1","arms":[{"description":"eryaspase 100 U/kg dosed every 2 weeks in combination with\n\nGemcitabine plus abraxane (albumin-bound paclitaxel) administered on Days 1, 8, and 15 of each 4 week cycle as follows:\n\n* Abraxane (125 mg/m2) IV\n* Gemcitabine (1000 mg/m2) IV\n\nOr\n\nIrinotecan plus 5-FU plus leucovorin administered on Days 1 and 15 of each 4 week cycle as follows:\n\n* Onivyde 70 mg/m2 (irinotecan freebase) IV (recommended dose in patients homozygous for UGT1A1\\*28 is 50 mg/m2)\n* Leucovorin 400 mg/m2 IV\n* 5 FU 2400 mg/m2\n\nOr\n\n* FOLFIRI: Irinotecan 180 mg/m2 IV\n* Leucovorin 400 mg/m² IV\n* 5 FU 400 mg/m² IV bolus\n* 5 FU 2400 mg/m² IV continuous infusion over 46 hours immediately following bolus 5 FU","label":"Eryaspase plus Chemotherapy","type":"EXPERIMENTAL"},{"description":"Standard treatment: Gemcitabine plus abraxane (albumin-bound paclitaxel) administered on Days 1, 8, and 15 of each 4 week cycle Or Irinotecan plus 5-FU plus leucovorin administered on Days 1 and 15 of each 4 week cycle","label":"Chemotherapy alone","type":"OTHER"}],"collaborators":[],"completion_date":{"date":"2022-01-18","type":"ACTUAL"},"conditions":["Pancreatic Adenocarcinoma"],"enrollment":{"count":512,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"eryaspase","otherNames":["L-asparaginase"],"type":"DRUG"},{"name":"Gemcitabine plus Abraxane","otherNames":["Gemzar, nab-paclitaxel, onxol"],"type":"DRUG"},{"name":"Irinotecan plus 5-FU plus leucovorin","otherNames":["Onivyde, liposomal irinotecan, Camptosar, Campto, Adrucil, Carac, Efudex, Efudix, folinic acid, calcium folinate"],"type":"DRUG"}],"last_update":"2022-10-18","lead_sponsor":"ERYtech Pharma","official_title":"A Randomized, Phase 3 Study of Eryaspase in Combination With Chemotherapy Versus Chemotherapy Alone as 2nd-Line Treatment of Patients With Pancreatic Adenocarcinoma","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2021-08-30","type":"ACTUAL"},"primary_outcomes":[{"measure":"Overall Survival (OS)","timeFrame":"~12 months"}],"references":[{"citation":"Hammel P, Metges JP, Macarulla Mercade T, Garcia-Carbonero R, Bouche O, Portales F, Pazo Cid RA, Mineur L, Cubillo Gracian A, Trouilloud I, Guimbaud R, Tougeron D, Reina JJ, Feliu J, Sauri T, Fountzilas C, Lecomte T, Molin Y, Ponz-Sarvise M, Forget F, Berardi R, Van Cutsem E, Gelsomino F, Tournigand C, Bockorny B, Bachet JB, Marin Vera M, Cuyle PJ, Wasan H, Noel M, Van Laethem JL, Kay R, Youssoufian H, El-Hariry I, Hidalgo M. TRYBECA-1: A Randomized Phase III Study of Eryaspase Combined With Chemotherapy Versus Chemotherapy as Second-Line Treatment in Patients With Advanced Pancreatic Adenocarcinoma. J Clin Oncol. 2025 Dec 10;43(35):3714-3727. doi: 10.1200/JCO-25-00872. Epub 2025 Nov 4.","pmid":"41187298","type":"DERIVED"}],"start_date":{"date":"2018-09-15","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Study of Eryaspase in Combination With Chemotherapy Versus Chemotherapy Alone as 2nd-Line Treatment in PAC","url":"https://clinicaltrials.gov/study/NCT03665441"},"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/trybeca-1-nct03665441"}