A Prospective, Multicenter, Study of APF530 (Granisetron) SC for Prevention of CINV in Patients Receiving HEC
Status:
Completed
Trial end date:
2015-05-01
Target enrollment:
Participant gender:
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