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

A Randomized, Dose-ranging, Open-label, Parallel Group Study to Assess the Efficacy, Safety and Pharmacokinetics of Palonosetron HCl Buccal Film Versus IV Palonosetron 0.25 mg for the Prevention of CINV in Cancer Patients Receiving MEC

Phase 2 study to compare efficacy, safety and PK of palonosetron, a long acting 5-HT3 receptor antagonist, by buccal film delivery compared to iv injection for chemotherapy induced nausea or vomiting (CINV). Subjects receive a single dose of palonosetron prior to moderately emetogenic chemotherapy.

This is a Phase 2 study to compare efficacy, safety and PK of palonosetron, a long acting 5-HT3 receptor antagonist, by buccal film compared to iv injection for moderately emetogenic chemotherapy-induced nausea or vomiting (CINV) in cancer patients. Subjects are randomized into three treatment groups, two with the experimental study drug palonosetron in buccal film at one of two different doses or the control treatment using Palonosetron hydrochloride iv injection. Palonosetron PK will be assessed in a subgroup of each treatment group.

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.