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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

477 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-13

Study Completion Date

2004-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Nausea Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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MK0869, aprepitant / Duration of Treatment: 3 days

Intervention Type DRUG

Comparator: ondansetron / Duration of Treatment: 4 days

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No