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A Pivotal Phase 3 Observer-Blind Randomized Clinical Trial of the Efficacy and Safety of APF530 Compared to Aloxi For The Prevention of Acute-Onset and Delayed-Onset Chemotherapy-Induced Nausea and Vomiting Following The Administration of Either Moderately or Highly Emetogenic Chemotherapy Regimens.

Trial Profile

A Pivotal Phase 3 Observer-Blind Randomized Clinical Trial of the Efficacy and Safety of APF530 Compared to Aloxi For The Prevention of Acute-Onset and Delayed-Onset Chemotherapy-Induced Nausea and Vomiting Following The Administration of Either Moderately or Highly Emetogenic Chemotherapy Regimens.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 28 Feb 2017

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At a glance

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

    • 11 Aug 2016 According to a Heron Therapeutics media release, based on this and other study (CTP 700243242) the US FDA has approved granisetron extended-release injection for the prevention of chemotherapy-induced nausea and vomiting.
    • 18 Apr 2016 According to a Heron Therapeutics media release, the US FDA has indicated that there are no substantive deficiencies in the NDA and has begun labeling discussions with the Company.
    • 19 May 2014 According to a Heron Therapeutics media release, results will be presented at the 2014 American Society of Clinical Oncology Meeting.
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