An Efficacy and Safety Study of Palonosetron in Preventing Chemotherapy-Induced Nausea and Vomiting (CINV) in the Chinese Cancer Patients

A Phase II, Multicenter,Double-Blind, Randomized Trial of Palonosetron Compared With Granisetron in Preventing Highly Emetogenic Chemotherapy-Induced Nausea and Vomiting in the Chinese Cancer Patients

This clinical study was designed to demonstrate that a single, intravenous dose of palonosetron 0.25 mg was not inferior to granisetron 3 mg in preventing acute and delayed CINV and was also well tolerated in the Chinese cancer patients.

Inclusion Criteria:

• Male or female, age ranging from 18 yrs to 70 yrs, with histologically or cytologically confirmed malignant disease
• naive to chemotherapy or nonnaive with an interval of at least 14 days to the last one
• Karnofsky index more than 70% and anticipated survival time more than 90 days
• Scheduled to receive any of the following cytotoxic agents based combination chemotherapy (epirubicin 60 mg/m2, or cisplatin 75 mg/m2) on study Day 1 and the chemotherapy should be accomplished on study Day 1
• No emetic episodes and antiemetic medication during the 24 hours preceding chemotherapy administration
• Adequate organ functions(No impairment to renal, hepatic, cardiac or bone marrow function )
• Use of reliable contraceptive measures (for females of childbearing potential) and negative pregnancy test at baseline visit
• Provision of written informed consent

Exclusion Criteria:

• Inability to understand or cooperate with study procedures
• Receipt of investigational drugs 30 days before study entry
• Scheduled to receive any drug with antiemetic efficacy from 24 hrs before to 5 days after treatment
• Contraindications to 5-HT3 receptor antagonists
• Woman Patient with Pregnancy or lactation
• Diagnosed with hypertension or severe infectious diseases
• Obstructive symptom of gastrointestinal tract
• Symptomatic brain metastasis or mental dysfunction
• Baseline QTc > 500 ms