Randomized, Double-blind, Double-dummy, Parallel Group Study to Assess the Efficacy and Safety of Palonosetron HCl Buccal Film versus IV Palonosetron 0.25 mg for the Prevention of Chemotherapy-induced Nausea and Vomiting in Cancer Patients Receiving Moderately Emetogenic Chemotherapy
DISEASE:
Chemotherapy-induced Nausea and Vomiting
SUMMARY:
Palonosetron is an approved drug used for the prevention of chemotherapy-induced nausea and vomiting, known as an anti-emetic. The drug is typically given Intravenously (IV), but this study is looking at the effectiveness of the drug when administered via a buccal film, which is a thin film you place on the inside of your cheek, allowing the drug to dissolve and absorb. Patients who go on the study will be randomized to either one of two treatment groups: The Test group, who will receive Buccal Film Palonosetron, and the Reference group, who will receive IV Palonosetron. The goal of this study is to compare the effectiveness and safety of single dose Palonosetron HCl Buccal Film vs. IV for the prevention of chemotherapy-induced nausea and vomiting.
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