An Efficacy and Safety Study of Intravenous Palonosetron Administered as an Infusion and as a Bolus for the Prevention of Nausea and Vomiting

Inclusion Criteria:

• Signed written informed consent

• Histologically or cytologically confirmed solid tumor malignancy.

• Naïve to cytotoxic chemotherapy. Previous biological or hormonal therapy will bepermitted.

• Scheduled to receive first course of one of the following reference HEC, alone or incombination with other chemotherapeutic agents on Day 1:

• cisplatin administered as a single IV dose of ≥ 70 mg/m2

• cyclophosphamide ≥1500 mg/m2

• carmustine (BCNU) >250 mg/m2

• dacarbazine (DTIC)

• mechloretamine (nitrogen mustard)

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2 .

• If a patient is female, she shall be of non-childbearing potential or of childbearingpotential using reliable contraceptive measures and having a negative urine pregnancytest.

• Hematologic and metabolic status adequate for receiving an highly emetogenic regimenbased on laboratory criteria (Total Neutrophils,Platelets, Bilirubin, Liver enzymes,Serum Creatinine or Creatinine Clearance)

• Able to read, understand, follow the study procedure and complete patient diary.

Exclusion Criteria:

• Lactating woman.

• Current use of illicit drugs or current evidence of alcohol abuse.

• Scheduled to receive moderately emetogenic chemotherapy or highly emetogenicchemotherapy from Day 2 to Day 5.

• Received or is scheduled to receive radiation therapy to the abdomen or the pelviswithin 1 week prior to the start of the reference HEC administration on Day 1 orbetween Days 1 to 5.

• Any vomiting, retching, or nausea (grade ≥ 1 as defined by National Cancer Institute)within 24 hours prior to the start of the reference HEC administration on Day 1.

• Symptomatic primary or metastatic CNS malignancy.

• Active peptic ulcer disease, gastrointestinal obstruction, increased intracranialpressure, hypercalcemia, an active infection or any illness or medical conditions (other than malignancy) that, in the opinion of the Investigator, may confound theresults of the study, represent another potential etiology for emesis and nausea (other than chemotherapy-induced nausea and vomiting) or pose unwarranted risks inadministering the study drugs to the patient.

• Known hypersensitivity or contraindication to 5-HT3 receptor antagonists

• Known contraindication to the IV administration of 50 mL 5% glucose solution.

• Participation in a previous clinical trial involving palonosetron.

• Any investigational drugs (other than those given in this study) taken within 4 weeksprior to Day 1, and/or is scheduled to receive any investigational drug during thepresent study.

• Systemic corticosteroid therapy at any dose within 72 hours prior to the start of thereference HEC administration on Day 1. However, topical and inhaled corticosteroidsare permitted.

• Scheduled to receive bone marrow transplantation and/or stem cell rescue therapy.

• Any medication with known or potential antiemetic activity within 24 hours prior tothe start of the reference HEC administration on Day 1, including but not limited to 5-HT3 receptor antagonists and NK-1 receptor antagonists

• Concurrent medical condition that would preclude administration of dexamethasone for 4days such as systemic fungal infection or uncontrolled diabetes.