An Efficacy and Safety Study of Oral and Intravenous Palonosetron for the Prevention of Nausea and Vomiting
Status:
Completed
Trial end date:
2012-11-01
Target enrollment:
Participant gender:
Summary
PALO-10-01 is a clinical study assessing efficacy and safety of a single oral dose of
palonosetron compared to a single intravenous dose of palonosetron (Aloxi, an antiemetic
drug), both given with oral dexamethasone. The objective of the study is to demonstrate that
oral palonosetron 0.50 mg is as effective as (non-inferior to) palonosetron IV 0.25 mg to
prevent nausea and vomiting induced by highly emetogenic cancer chemotherapy in the 0-24
hours after administration of a single cycle of highly emetogenic chemotherapy.