A RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP STUDY, INDUCED UNDER INTERNAL BLIND CONDITIONS, TO DETERMINE THE SAFETY, TOLERABILITY, AND EFFECTIVENESS OF THE APREPITANT REGIME COMPARED TO AN ONDASETRON REGIME FOR THE PREVENTION OF NAUSEA AND VOMITES INDUCED BY CHEMOTHERAPY, ASSOCIATED WITH HIGH DOSE OF CISPLATINO IN CYCLE 1.

Not Applicable

• Conditions: -R11 Nausea and vomiting; Nausea and vomiting; R11

• Registration Number: PER-057-03
• Lead Sponsor: MERCK & CO.INC.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2003-10-28
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

The patient is> 18 years of age.
The patient is scheduled to receive his first cycle of cisplatin chemotherapy for a malignant solid tumor documented at a dose of> 70 mg / m administered for <3 hours.
The patient has Kamofsky score> 60.
The patient has a predicted life expectancy of> 3 months.

Exclusion Criteria

The patient is mentally incapacitated or has a significant emotional or psychiatric disorder that, in the opinion of the investigator, excludes him from participating in the study.
The patient receives stem cell rescue therapy along with the cisplatin chemotherapy cycle.
The patient has received an unapproved (investigational) drug within the last 4 weeks.

Study & Design

• Study Type: Interventional
• Study Design: Not specified