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

NCT ID: NCT00684463

Last Updated: 2017-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-11
• Study Completion Date: 2008-02-22

Brief 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.

Conditions

Neoplasms; Nausea; Vomiting

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Palonosetron

0.25 mg IV single dose, 30 minutes prior to the administration of the major chemotherapeutic agent

Group Type: EXPERIMENTAL

Palonosetron

Intervention Type: DRUG

0.25 mg IV single dose, 30 minutes prior to the administration of the major chemotherapeutic agent.

Interventions

Palonosetron

0.25 mg IV single dose, 30 minutes prior to the administration of the major chemotherapeutic agent.

Intervention Type: DRUG

Other Intervention Names

SCH 734291 - Onicit®

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Study Documents

Document Type: CSR Snyopsis

View Document

Other Identifiers

P04935

Identifier Type: -

Identifier Source: org_study_id