Abstract
Background The global, phase 3 study (NAPOLI-1) demonstrated that nal-IRI, a liposomal formulation of irinotecan (BAX2398, MM-398), in combination with 5-FU/LV significantly improved overall survival (OS) in patients with mPAC previously treated with gemcitabine-based therapy compared with 5-FU/LV (6.1 vs 4.2 months; unstratified hazard ratio 0.67; [95% CI 0.49–0.92; P¼ .012]). The most frequent _grade 3 adverse events in the nal-IRIþ5-FU/LV–treated patients were neutropenia(27%), diarrhea (13%), vomiting (11%), and fatigue (14%) (Wang-Gillam A. Lancet. 2016). Trial design: The ongoing open-label, phase 2 study (ClinicalTrials.gov, NCT02697058) is designedto evaluatethe safety, PK, and efficacy of nal-IRI+5-FU/ calcium levofolinate in Japanese patients with mPAC that progressed or recurred after priorgemcitabine-basedtherapy.This2partstudyinvolvesasafetyrun-in(part1)and a randomized, open-label study (part 2). Key eligibility criteria include: age >20 years; pathologically confirmed pancreatic cancer; metastatic disease with at least 1 measurablelesionasdefinedbyRECISTv1.1guidelines;documenteddisease progression afterpriorgemcitabine-containingtherapy; KPS >70; noknown metastases to the central nervous system; and adequate hematologic, hepatic, and renal functions.Theprimaryobjectivesofpart1aretoassessthesafetyandtolerabilityofnal- IRI+5-FU/calcium levofolinate and to characterize the PK of nal-IRI in at least 6 patients. Inpart2, an additional 74patients willbe randomlyassigned 1:1to nal-IRI+5- FU/calciumlevofolinatealone(armA)or5-FU/calciumlevofolinate(armB)with progression-freesurvivalastheprimaryobjective. Secondaryobjectivesofpart2 include characterization ofPK and safety, and between-arm comparison ofobjective response rate, OS, time to treatment failure, disease control rate, CA19-9 response, and patient-reportedoutcomesusingtheEuropeanOrganizationfortheResearchand TreatmentofCancerQualityofLifeQuestionnairecoremodule(EORTC-QLQ-C30) and patient diary. This study is currently recruiting patients at 16 sites in Japan. Legal entity responsible for the study Shire Japan KK Funding Shire Japan KK Disclosure T. Ioka: Taiho, Astrazeneca, Yakult Honsha, Baxata and JCRO Speaker's bureau; Taiho, Yakult Honsha, Daiichi Sankyo, Eisai, Mochida and Fuji Film Research fundings; Merk Serono, Taiho, Astrazeneca, Glaxo Smithkline, Nihon Zouki and Zeria. M. Ueno: Honoraria: Abbott; AstraZeneca; Boston Scientific; Kyowa Hakko Kirin; Lilly; Novartis; Taiho Pharmaceutical; Yakult Honsha; Research: AstraZeneca; Daiichi Sankyo; Eisai; Merck Serono; Taiho Pharmaceutical; Zeria Pharmaceutical. H. Ueno: Honoraria: Taiho Pharmaceutical Co., Ltd. Research Funding: Taiho Pharmaceutical Co.,Ltd;NanoCarrierCo.,Ltd.;BaxaltaJapanLimited.S.Kabir,T.Tokudome:Shire employee. M. Ikeda: Honoraria: Taiho, Research funding: Taiho.
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