A Phase III Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled, Parallel Group Study of the Efficacy and Safety of Oral Netupitant Administered in Combination With Palonosetron and Dexamethasone Compared to Oral Palonosetron and Dexamethasone for the Prevention of Nausea and Vomiting in Cancer Patients Receiving Moderately Emetogenic Chemotherapy

Trial Profile

A Phase III Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled, Parallel Group Study of the Efficacy and Safety of Oral Netupitant Administered in Combination With Palonosetron and Dexamethasone Compared to Oral Palonosetron and Dexamethasone for the Prevention of Nausea and Vomiting in Cancer Patients Receiving Moderately Emetogenic Chemotherapy

Completed
Phase of Trial: Phase III

Latest Information Update: 01 Apr 2017

At a glance

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

    • 02 Jun 2015 According to Helsinn media release, the European Commission has approved netupitant/palonestron [AKYNZEO] for the prevention of acute and delayed nausea and vomiting associated with cancer chemotherapy.
    • 08 May 2015 According to a Specialised Therapeutics Australia media release, Akynzeo was approved by the Therapeutics Goods Agency (TGA) for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately and highly emetogenic cancer chemotherapy. The approval was based on results from this and other phase II and III trials (see profile 70023353 and 700201211).
    • 30 Mar 2015 According to Helsinn media release, European Medicines Agency (EMA) has adopted a positive opinion about approval for the prevention of acute and delayed nausea and vomiting associated with cancer chemotherapy, recommended by Committee for Medicinal Products for Human Use (CHMP). The opinion was based on data from this and other phase II and III trials.
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