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A Phase 3, Multicenter, Randomized, Double-Blind, Active-Controlled Study of the Safety and Efficacy of Rolapitant for the Prevention of Chemotherapy- Induced Nausea and Vomiting (CINV) in Subjects Receiving Moderately Emetogenic Chemotherapy (MEC).

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Trial Profile

A Phase 3, Multicenter, Randomized, Double-Blind, Active-Controlled Study of the Safety and Efficacy of Rolapitant for the Prevention of Chemotherapy- Induced Nausea and Vomiting (CINV) in Subjects Receiving Moderately Emetogenic Chemotherapy (MEC).

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 27 Oct 2017

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At a glance

  • Drugs Rolapitant (Primary) ; Dexamethasone; Granisetron
  • Indications Chemotherapy-induced nausea and vomiting
  • Focus Registrational; Therapeutic Use
  • Acronyms MEC
  • Sponsors TESARO
  • Most Recent Events

    • 25 Oct 2017 According to a Tesaro media release, the U.S. Food and Drug Administration (FDA) has approved VARUBI (rolapitant) IV in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy.
    • 26 Apr 2017 According to a Tesaro media release, the European Commission (EC) has approved VARUBY (oral rolapitant tablets) for the prevention of delayed nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in adults,based on data from this and 3 other trials.
    • 27 Feb 2017 According to a Tesaro media release,the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion for the Company's marketing authorization application (MAA) for VARUBY (oral rolapitant tablets) for the prevention of delayed nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in adults based on data from this and 3 other trials.
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