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

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 4

Conditions

Vomiting

Nausea

Neoplasms

Treatments

Drug: Palonosetron

Study type

Interventional

Funder types

Industry

Identifiers

NCT00684463

P04935

Details and patient eligibility

About

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.

Enrollment

59 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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