NAPOLI-3: An open-label, randomized, phase III study of first-line liposomal irinotecan+5-fluorouracil/leucovorin plus oxaliplatin versus nab-paclitaxel plus gemcitabine in patients with metastatic pancreatic ductal adenocarcinoma
dc.contributor.author | Wainberg, Z. A. | |
dc.contributor.author | Bekaii-Saab, T. S. | |
dc.contributor.author | Hubner, Richard A | |
dc.contributor.author | Macarulla, T. | |
dc.contributor.author | Paulson, A. S. | |
dc.contributor.author | Van Cutsem, E. | |
dc.contributor.author | Maxwell, F. | |
dc.contributor.author | Moore, Y. | |
dc.contributor.author | Wang, H. T. | |
dc.contributor.author | Zhang, B. | |
dc.contributor.author | O'Reilly, E. M. | |
dc.date.accessioned | 2021-04-06T15:07:08Z | |
dc.date.available | 2021-04-06T15:07:08Z | |
dc.date.issued | 2020 | en |
dc.identifier.citation | Wainberg ZA, Bekaii-Saab TS, Hubner R, Macarulla T, Paulson AS, Van Cutsem E, et al. NAPOLI-3: An open-label, randomized, phase III study of first-line liposomal irinotecan + 5-fluorouracil/leucovorin + oxaliplatin versus nab-paclitaxel + gemcitabine in patients with metastatic pancreatic ductal adenocarcinoma. Journal of Clinical Oncology. 2020;38(15_suppl):TPS4661-TPS. | en |
dc.identifier.doi | 10.1200/JCO.2020.38.15_suppl.TPS4661 | en |
dc.identifier.uri | http://hdl.handle.net/10541/623879 | |
dc.description.abstract | Background: Liposomal irinotecan administered with 5-fluorouracil/leucovorin (5-FU/LV) is approved in the USA for metastatic pancreatic ductal adenocarcinoma (mPDAC) following progression with gemcitabine-based therapy. A phase 1/2 study in previously untreated locally advanced/metastatic PDAC showed promising anti-tumor activity with liposomal irinotecan 50 mg/m2 free base + 5-FU 2400 mg/m2 + LV 400 mg/m2 + oxaliplatin (OX) 60 mg/m2 on days 1 and 15 of a 28-day cycle (Wainberg et al. Ann Oncol 2019;30 Suppl 4: SO-005). Herein, we present the design of the phase 3 NAPOLI-3 study investigating the efficacy and safety of this regimen as first-line therapy in patients with mPDAC. Methods: NAPOLI-3 (NCT04083235) is a phase 3, open-label, randomized, global study in adults with histologically/cytologically confirmed pancreatic adenocarcinoma not previously treated in the metastatic setting. Patients are required to have one or more metastatic tumors measurable with computed tomography/magnetic resonance imaging and an Eastern Cooperative Oncology Group performance status score of 0–1. Site activation began in Dec 2019 and enrollment is ongoing. Random allocation (1:1) of 750 patients is planned to liposomal irinotecan + 5-FU/LV + OX (regimen as per phase 1/2 study) or nab-paclitaxel 125 mg/m2 + gemcitabine 1000 mg/m2 on days 1, 8 and 15 in a 28-day cycle. The primary endpoint is overall survival (OS). Secondary endpoints (progression-free survival [PFS] and overall response rate assessed with Response Evaluation Criteria in Solid Tumors v1.1 criteria) will be compared only if the primary endpoint shows superiority for liposomal irinotecan + 5-FU/ LV + OX over nab-paclitaxel + gemcitabine. Safety assessments include adverse-event monitoring. Patients will continue treatment until disease progression, unacceptable toxicity or study withdrawal, and will then be followed for survival every 2 months until death or study end (when all patients have died, withdrawn consent or are lost to follow-up). | en |
dc.language.iso | en | en |
dc.relation.url | https://dx.doi.org/10.1200/JCO.2020.38.15_suppl.TPS4661 | en |
dc.title | NAPOLI-3: An open-label, randomized, phase III study of first-line liposomal irinotecan+5-fluorouracil/leucovorin plus oxaliplatin versus nab-paclitaxel plus gemcitabine in patients with metastatic pancreatic ductal adenocarcinoma | en |
dc.type | Meetings and Proceedings | en |
dc.contributor.department | University of California, Los Angeles, Medical Center, Los Angeles, CA | en |
dc.identifier.journal | Journal of Clinical Oncology | en |
dc.description.note | en] |