Evaluation of Fosaprepitant (MK0517) in Single Dose Schedule (0517-017) (EASE)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Chemotherapy-Induced Nausea and Vomiting (CINV)

Treatments: Drug: Comparator: fosaprepitant dimeglumine; Drug: Dexamethasone; Drug: Ondansetron; Drug: Comparator: Aprepitant

Study type: Interventional

Funder types: Industry

Identifiers

NCT00619359

2007_594

MK0517-017

0517-017

Details and patient eligibility

About

The purpose of this study is to examine the safety, tolerability, and efficacy of MK0517 to prevent Chemotherapy-Induced Nausea and Vomiting (CINV) associated with Cisplatin chemotherapy.

Enrollment: 2,322 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient is male or female and is at least 18 years of age; scheduled to receive his or her first course of cisplatin chemotherapy at a dose of 70 mg/m2 or higher; predicted life expectancy of 3 months or greater
• Patient is post menopausal or, if premenopausal, must use double-barrier contraception

Exclusion criteria

• Patient has symptomatic primary or metastatic CNS malignancy
• Patient has received or will receive Radiation therapy to the abdomen or pelvis in the week prior to Treatment Day 1 though Day 6
• Patient has vomited in the 24 hours prior to treatment Day 1
• Patient has an active infection; Patient uses illicit drugs or has current evidence of alcohol abuse
• Patient is pregnant or breast feeding

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2,322 participants in 2 patient groups

1

Experimental group

Description:

Arm 1: study medication

Treatment:

Drug: Dexamethasone

Drug: Dexamethasone

Drug: Ondansetron

Drug: Comparator: fosaprepitant dimeglumine

2

Active Comparator group

Description:

Arm 2: Active comparator

Treatment:

Drug: Dexamethasone

Drug: Dexamethasone

Drug: Ondansetron

Drug: Comparator: Aprepitant