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A randomized, double-blind, double-dummy, parallel group, international multi center study assessing the efficacy and safety of a netupitant-palonosetron Fixed Dose Combination (FDC) compared to an extemporary combination of granisetron and aprepitant on the prevention of highly emetogenic chemotherapy-induced nausea and vomiting in patients with cancer

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Trial Profile

A randomized, double-blind, double-dummy, parallel group, international multi center study assessing the efficacy and safety of a netupitant-palonosetron Fixed Dose Combination (FDC) compared to an extemporary combination of granisetron and aprepitant on the prevention of highly emetogenic chemotherapy-induced nausea and vomiting in patients with cancer

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 23 Oct 2024

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At a glance

  • Drugs Netupitant/palonosetron (Primary) ; Aprepitant; Dexamethasone; Granisetron
  • Indications Chemotherapy-induced nausea and vomiting
  • Focus Registrational; Therapeutic Use
  • Sponsors Helsinn
  • Most Recent Events

    • 01 Jul 2018 According to a Helsinn media release, AKYNZEO is approved in Korea for prevention of acute and delayed nausea and vomiting associated with highly emetogenic cancer chemotherapy and prevention of acute and delayed nausea and vomiting associated with moderately emetogenic cancer chemotherapy.
    • 28 Oct 2017 Results published in the Annals of Oncology Journal.
    • 18 Oct 2017 Results of a post-hoc analysis assessing the efficacy of the Netupitant/palonosetron versus Aprepitant/Granisetron within the lung cancer subset of patients (n=542), presented at the 18th World Conference on Lung Cancer.

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