Aprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) Associated With Highly Emetogenic Chemotherapy (0869-801)(COMPLETED)

Merck Sharp & Dohme LLC477 enrolled

Overview

A multicenter trial to assess the safety and efficacy of an investigational drug in the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with confirmed solid tumors who will be treated with a chemotherapy regimen that includes cisplatin. The study will evaluate the investigational drug for the treatment of CINV during the first cycle of treatment with cisplatin.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

477

Conditions

Nausea Vomiting

Interventions

MK0869, aprepitant / Duration of Treatment: 3 daysDRUG

Comparator: ondansetron / Duration of Treatment: 4 daysDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient is greater than 18 years of age. * Patient is scheduled to receive his/her first course of cisplatin chemotherapy for a solid tumor. * Patient has a prognosis (life expectancy) greater than or equal to 3 months.

Outcomes

Primary Outcomes

Patient vomiting

Secondary Outcomes

Number of rescue therapies

Data from ClinicalTrials.gov

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