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NAPOLI 1: A Randomized, Open Label Phase 3 Study of MM-398, with or without 5-Fluorouracil and Leucovorin, versus 5-Fluorouracil and Leucovorin, in Patients with Metastatic Pancreatic Cancer Who have Failed Prior Gemcitabine-based Therapy

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Trial Profile

NAPOLI 1: A Randomized, Open Label Phase 3 Study of MM-398, with or without 5-Fluorouracil and Leucovorin, versus 5-Fluorouracil and Leucovorin, in Patients with Metastatic Pancreatic Cancer Who have Failed Prior Gemcitabine-based Therapy

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 17 Aug 2022

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At a glance

  • Drugs Irinotecan (Primary) ; Fluorouracil; Folinic acid
  • Indications Adenocarcinoma; Pancreatic cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms NAPOLI-1
  • Sponsors Merrimack Pharmaceuticals

    • Most Recent Events

    • 01 Feb 2020 Results of post hoc subgroup anlysis assessing safety and efficacy of irinotecan in Asian patients published in the Cancer Science
    • 14 Jan 2019 Results evaluating the final survival analysis and baseline characteristics associated with long-term survivors published in the European Journal of Cancer
    • 17 Nov 2018 Results assessing HRQoL in metastatic pancreatic cancer patients receiving liposomal irinotecan plus 5-fluorouracil and leucovorin, published in the European Journal of Cancer

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