A multicenter, randomized, double-blind, parallel group study to evaluate the efficacy and safety of two different doses of palonosetron compared to ondansetron in the prevention of CINV in pediatric patients undergoing single and repeated cycles of MEC or HEC

Trial Profile

A multicenter, randomized, double-blind, parallel group study to evaluate the efficacy and safety of two different doses of palonosetron compared to ondansetron in the prevention of CINV in pediatric patients undergoing single and repeated cycles of MEC or HEC

Completed
Phase of Trial: Phase III

Latest Information Update: 30 Sep 2017

At a glance

  • Drugs Palonosetron (Primary) ; Ondansetron
  • Indications Chemotherapy-induced nausea and vomiting
  • Focus Registrational; Therapeutic Use
  • Sponsors Helsinn
  • Most Recent Events

    • 18 Jan 2016 Efficacy analysis (n=493) published in the Lancet Oncology.
    • 02 Jun 2015 Results presented at the 51st Annual Meeting of the American Society of Clinical Oncology.
    • 27 May 2015 According to a Helsinn media release, palonosetron HCl received approval from the European commission for the indication chemotherapy induced nausea and vomiting based on this trial. As per the media release, this is the first European approval of a product for the prevention of acute chemotherapy-induced nausea and vomiting (CINV) in children aged one to six months.
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