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.

Completed
Phase of Trial: Phase III

Latest Information Update: 28 Feb 2017

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.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top