Palonosetron in Moderately and Highly Emetogenic Chemotherapy Induced Nausea and Vomiting (Study P04935)(COMPLETED)

Study to Evaluate the Efficacy and Safety of Single IV Doses of Onicit® (Palonosetron) 0.25 mg in the Prevention of Acute and Delayed Nausea and Vomiting Associated With Moderate and Highly Emetogenic Chemotherapy in Colombia

The purpose of this study is to evaluate the efficacy and safety of single IV doses of Onicit® (Palonosetron) 0.25 mg in the prevention of acute and delayed nausea and vomiting associated with moderate and highly emetogenic chemotherapy.

Inclusion Criteria:

• Patients must be 18 years of age or older.
• Histological or cytological confirmation of malignant disease.
• Karnofsky index >= 50%
• Naïve to chemotherapy (First Cycle of chemotherapy IV with moderate or high emetic risk administered during Day 1 of the study, according to modification of the classification of Paul Hesketh's schema published on Annals of Oncology 17: 20-28, 2006 (Appendix 3).
• Patients that voluntarily sign the consent form.

Exclusion Criteria:

• Pregnancy or suspected.
• Patients during breast feeding.
• Inability to understand or cooperate with the study procedures.
• Received any investigational drugs within 30 days before study entry.
• Received any drug with potential anti-emetic efficacy within 24 hours prior to the beginning of the treatment
• Seizure disorders requiring anticonvulsant medication.
• Persistent vomiting due to any organic etiology.
• Experienced any vomiting, nausea or retching, in the 24 hours prior to chemotherapy.
• Any systemic disease different to base disease
• Known current or history of drug or alcohol abuse
• Gastric outlet or intestinal obstruction