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

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf

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