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A Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled, Parallel Group Phase 3b Study to Assess the Safety and to Describe the Efficacy of IV Fosnetupitant/Palonosetron (260 mg/0.25 mg) Combination (IV NEPA FDC) Compared to Oral Netupitant/Palonosetron (300 mg/0.5 mg) Combination (Akynzeo) for the Prevention of Chemotherapy-induced Nausea and Vomiting in Initial and Repeated Cycles of Anthracycline-cyclophosphamide (AC) Chemotherapy in Women With Breast Cancer

Trial Profile

A Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled, Parallel Group Phase 3b Study to Assess the Safety and to Describe the Efficacy of IV Fosnetupitant/Palonosetron (260 mg/0.25 mg) Combination (IV NEPA FDC) Compared to Oral Netupitant/Palonosetron (300 mg/0.5 mg) Combination (Akynzeo) for the Prevention of Chemotherapy-induced Nausea and Vomiting in Initial and Repeated Cycles of Anthracycline-cyclophosphamide (AC) Chemotherapy in Women With Breast Cancer

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 04 Jun 2019

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At a glance

  • Drugs Netupitant/palonosetron (Primary) ; Dexamethasone; Netupitant/palonosetron
  • Indications Chemotherapy-induced nausea and vomiting
  • Focus Adverse reactions
  • Sponsors Helsinn Healthcare SA
  • Most Recent Events

    • 04 Jun 2019 Results presented at the 55th Annual Meeting of the American Society of Clinical Oncology
    • 31 May 2019 Results published in the Helsinn Media Release.
    • 31 May 2019 According to an Helsinn Media release, data on the intravenous formulation of NEPA (Akynzeo) will be presented as poster at the American Society of Clinical Oncology (ASCO) Congress in June 2019.
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