{"commentary":{"count":16,"free_build_floor":8,"listing_floor":3,"by_channel":{"podcast":11,"youtube":5},"note":"Indexed podcasts, YouTube videos and X posts that name this trial. A report screens them, searches for more and cites what clinicians said when it is built."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT04083235\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's public preview; the full report is still bought."},"name":"NAPOLI 3","nct_id":"NCT04083235","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=napoli-3-nct04083235. The price is fixed at order. We build the report after the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":1250,"size":"standard","size_rule":"Standard: 13–40 commentary sources"},"registry":{"acronym":"NAPOLI 3","arms":[{"description":"Irinotecan liposome injection, oxaliplatin, 5 FU/LV, will be administered on Days 1 and 15 of each 28-day cycle (until progression or unacceptable toxicity).","label":"Irinotecan liposome injection + Oxaliplatin + 5-FU/LV","type":"EXPERIMENTAL"},{"description":"Nab-paclitaxel and gemcitabine will be administered on Days 1, 8 and 15 of each 28-day cycle (until progression or unacceptable toxicity).","label":"Nab-paclitaxel + Gemcitabine","type":"ACTIVE_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2025-02-18","type":"ACTUAL"},"conditions":["Metastatic Adenocarcinoma of the Pancreas"],"enrollment":{"count":770,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Irinotecan Liposomal Injection","type":"DRUG"},{"name":"Oxaliplatin","type":"DRUG"},{"name":"5Fluorouracil","type":"DRUG"},{"name":"Leucovorin","type":"DRUG"},{"name":"Nab-paclitaxel","type":"DRUG"},{"name":"Gemcitabine","type":"DRUG"}],"last_update":"2026-04-20","lead_sponsor":"Ipsen","official_title":"An Open-label, Randomised, Multicentre, Phase III Study of Irinotecan Liposome Injection, Oxaliplatin, 5-fluorouracil/Leucovorin Versus Nab-paclitaxel Plus Gemcitabine in Subjects Who Have Not Previously Received Chemotherapy for Metastatic Adenocarcinoma of the Pancreas","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2022-07-23","type":"ACTUAL"},"primary_outcomes":[{"measure":"Overall Survival (OS)","timeFrame":"Assessments performed at baseline (within 28 days before start of study treatment), every 8 weeks after first dose, end of treatment (EoT) visit, then every 2 months thereafter up to primary completion date (PCD) of 23 July 2022 (maximum of 893 days)"}],"references":[{"citation":"Abdelrahim M, Khan G, Hatoum H, Zervoudakis A, Dayyani F, Zhang L, Li J, Maxwell F, O'Reilly EM, Wainberg ZA, Bullock A. Impact of UGT1A1*28 polymorphism in patients with metastatic pancreatic ductal adenocarcinoma treated with NALIRIFOX in the NAPOLI 3 trial. Future Oncol. 2026 May;22(12):1421-1428. doi: 10.1080/14796694.2026.2664776. Epub 2026 May 4.","pmid":"42080361","type":"DERIVED"},{"citation":"Wainberg ZA, Melisi D, Macarulla T, Pazo Cid R, Chandana SR, De La Fouchardiere C, Dean A, Kiss I, Lee WJ, Goetze TO, Van Cutsem E, Paulson AS, Bekaii-Saab T, Pant S, Hubner RA, Xiao Z, Chen H, Benzaghou F, O'Reilly EM. NALIRIFOX versus nab-paclitaxel and gemcitabine in treatment-naive patients with metastatic pancreatic ductal adenocarcinoma (NAPOLI 3): a randomised, open-label, phase 3 trial. Lancet. 2023 Oct 7;402(10409):1272-1281. doi: 10.1016/S0140-6736(23)01366-1. Epub 2023 Sep 11.","pmid":"37708904","type":"DERIVED"}],"start_date":{"date":"2020-02-11","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study to Assess the Effectiveness and Safety of Irinotecan Liposome Injection, 5-fluorouracil/Leucovorin Plus Oxaliplatin in Patients Not Previously Treated for Metastatic Pancreatic Cancer, Compared to Nab-paclitaxel+Gemcitabine Treatment","url":"https://clinicaltrials.gov/study/NCT04083235"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"2.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/napoli-3-nct04083235"}