NCT02106494

A Prospective, Multicenter, Study of APF530 (Granisetron) SC for Prevention of CINV in Patients Receiving HEC

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 942 (actual)
• Sponsor: Heron Therapeutics · Industry
• Sex: All
• Age: 18 Years – 87 Years
• Healthy volunteers: Not accepted

Summary

The primary study objective is to demonstrate the superiority of APF530 500 mg given subcutaneously (SC) compared with ondansetron 0.15 mg/kg given intravenously (IV) (up to a maximum of 16 mg) in the delayed-phase (\> 24-120 hours) complete response (CR) rate (defined as no emesis and no use of rescue medications) in subjects receiving highly emetogenic chemotherapy (HEC) as defined by the 2011 ASCO CINV guidelines

Conditions

• Chemotherapy-induced Nausea and Vomiting

Interventions

Type	Name	Description
DRUG	APF530
DRUG	Ondansetron
DRUG	Ondansetron placebo
DRUG	APF530 placebo
DRUG	Fosaprepitant
DRUG	Dexamethasone

Timeline

• Start date: 2014-03-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2014-04-08
• Last updated: 2026-03-02
• Results posted: 2016-12-28

Locations

7 sites across 1 country: United States