Buccal Film Versus IV Injection Palonosetron for Moderately Emetogenic Chemotherapy Induced Nausea and Vomiting

Inclusion Criteria

• With histologically or cytologically confirmed malignant disease;

-. Be scheduled to receive the first course of MEC to be administered on Day 1

• Using reliable contraceptive measures;
• negative serum pregnancy test (if potentially child bearing)

Exclusion Criteria

• Received investigational drugs within 30 days before the start of study treatment or scheduled to receive a highly or moderately emetogenic chemotherapeutic agent;
• Have a clinically unstable seizure disorder with seizure activity requiring anticonvulsant medication;
• Have severe renal or hepatic impairment;
• Have positive serology test results;
• Have a known contraindication to 5-HT3 receptor antagonists;
• Treated with commercially available or investigative palonosetron formulation within 2 weeks prior to start of study treatment;
• Allergic to palonosetron or any other 5-HT3 antagonist;
• Currently a user of any recreational or illicit drugs (including marijuana) or has current evidence of drug or alcohol abuse or dependence as determined by the investigator;
• Will be receiving stem cell rescue therapy in conjunction with study related course of emetogenic chemotherapy;
• Received or will receive total body irradiation or radiation therapy to the abdomen or pelvis in the week prior to Treatment Day 1 and/or during the diary reporting period.