A Phase 3 Clinical Study Protocol: A Prospective, Randomized, Placebo-Controlled, Double-Blind, Multicenter, Phase 3 Study of APF530 500 mg SC, Fosaprepitant 150 mg IV, and Dexamethasone vs. Ondansetron 0.15 mg/kg IV, Fosaprepitant 150 mg IV, and Dexamethasone for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Patients Receiving Highly Emetogenic Chemotherapy

Trial Profile

A Phase 3 Clinical Study Protocol: A Prospective, Randomized, Placebo-Controlled, Double-Blind, Multicenter, Phase 3 Study of APF530 500 mg SC, Fosaprepitant 150 mg IV, and Dexamethasone vs. Ondansetron 0.15 mg/kg IV, Fosaprepitant 150 mg IV, and Dexamethasone for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Patients Receiving Highly Emetogenic Chemotherapy

Completed
Phase of Trial: Phase III

Latest Information Update: 30 Dec 2016

At a glance

  • Drugs Granisetron (Primary) ; Dexamethasone; Fosaprepitant; Ondansetron
  • Indications Chemotherapy-induced nausea and vomiting
  • Focus Registrational; Therapeutic Use
  • Acronyms MAGIC
  • Sponsors Heron Therapeutics
  • Most Recent Events

    • 11 Aug 2016 According to a Heron Therapeutics media release, based on this and other study (CTP 700011680) the US FDA has approved granisetron extended-release injection for the prevention of chemotherapy-induced nausea and vomiting.
    • 07 Jun 2016 Results (subgroup analysis, n = 902) assessing efficacy and safety by age and gender presented at the 52nd Annual Meeting of the American Society of Clinical Oncology.
    • 07 Jun 2016 Results presented at the 52nd Annual Meeting of the American Society of Clinical Oncology
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