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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

Completed
Phase of Trial: Phase III

Latest Information Update: 11 Jan 2019

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

    • 07 Jan 2019 Status changed from recruiting to completed.
    • 20 Mar 2018 Status changed from not yet recruiting to recruiting, according to a Helsinn media release.
    • 20 Mar 2018 According to a Helsinn media release, the first patient has been enrolled in this trial.
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