Buccal Film vs IV Palonosetron for Prevention of CINV in Cancer Patients Receiving MEC

Inclusion Criteria

• Male or female, at least 18-years of age;
• Provide written informed consent;
• Chemotherapy naïve subject with histologically or cytologically confirmed malignant disease; or chemotherapy non-naïve subject with histologically proven diagnosis of cancer;
• Karnofsky index ≥ 50;
• Be scheduled to receive MEC to be administered on Day 1;

Exclusion Criteria

• Unable to understand or cooperate with study procedure；
• Received any investigational drug 30 days prior to study entry；
• Used any drug with anti-emetic efficacy 24 hours prior to treatment and during the study；
• Enrollment in a previous study with palonosetron；
• Seizure disorder requiring anticonvulsant medication;
• Experienced any vomiting, retching, or NCI Common Toxicity Criteria grade 2 or 3 nausea in the 24 hours preceding chemotherapy；
• Ongoing vomiting from any organic etiology；
• Experienced nausea (moderate to severe or vomiting following any previous chemotherapy)；
• Scheduled to receive moderately or highly-emetogenic chemotherapy or radiotherapy during the study；
• Known contraindication to 5-HT3 antagonist or dexamethasone；
• Scheduled to receive bone marrow or stem cell transplant during study;
• Symptomatic primary or metastatic CNS malignancy;
• Lactating female.