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

• Status: Completed
• Trial end date: 2008-02-22
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Emetics; Palonosetron

Criteria

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