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A Phase 2, MultiCenter, Randomized, Placebo-Controlled, Double-Blind, Dose Finding Study to Determine the Safety and Efficacy of SCH 619734 for the Treatment of Chemotherapy Induced Nausea and Vomiting (CINV) in Subjects Receiving Highly Emetogenic Chemotherapy (HEC).

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Trial Profile

A Phase 2, MultiCenter, Randomized, Placebo-Controlled, Double-Blind, Dose Finding Study to Determine the Safety and Efficacy of SCH 619734 for the Treatment of Chemotherapy Induced Nausea and Vomiting (CINV) in Subjects Receiving Highly Emetogenic Chemotherapy (HEC).

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 04 Nov 2019

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At a glance

  • Drugs Rolapitant (Primary) ; Dexamethasone; Ondansetron
  • Indications Chemotherapy-induced nausea and vomiting
  • Focus Registrational; Therapeutic Use
  • Sponsors Schering-Plough; Schering-Plough Research Institute

Most Recent Events

  • 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.
  • 23 Feb 2017 Results of integrated safety analysis of four studies including this study published in the Annals of Oncology

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