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.
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
- 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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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History