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

February 14, 2017 updated by: Merck Sharp & Dohme LLC

A Phase III, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study, Conducted Under In-House Blinding Conditions, to Examine the Safety, Tolerability, and Efficacy of a Single Dose of Intravenous MK-0517 for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) Associated With Cisplatin Chemotherapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2322

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Arm 1: study medication
Drug: Comparator: fosaprepitant dimeglumine
single IV dose of 150 mg of fosaprepitant dimeglumine on Day 1.
Drug: Dexamethasone
Oral dose of 12 mg of dexamethasone on Day 1, 8 mg on Day 2, and 8 mg twice a day on Days 3-4.
Drug: Dexamethasone
Oral dose of 12 mg of dexamethasone on Day 1, and 8 mg on Days 2-4.
Drug: Ondansetron
single IV dose of 32 mg of ondansetron on Day 1.
Active Comparator: 2
Arm 2: Active comparator
Drug: Dexamethasone
Oral dose of 12 mg of dexamethasone on Day 1, 8 mg on Day 2, and 8 mg twice a day on Days 3-4.
Drug: Dexamethasone
Oral dose of 12 mg of dexamethasone on Day 1, and 8 mg on Days 2-4.
Drug: Ondansetron
single IV dose of 32 mg of ondansetron on Day 1.
Drug: Comparator: Aprepitant
Aprepitant 3-day dosing oral regimen (125 mg on Day 1 followed by 80 mg on Days 2 and 3).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A Complete Response (no Vomiting and no Use of Rescue Therapy) Overall (in the 120 Hours Following Initiation of Cisplatin).
Time Frame: Overall (in the 120 hours following initiation of cisplatin chemotherapy).
The number of patients who reported No Vomiting and No Use of Rescue Therapy in the 120 hours following initiation of cisplatin chemotherapy.
Overall (in the 120 hours following initiation of cisplatin chemotherapy).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A Complete Response (no Vomiting and no Use of Rescue Therapy) in the Delayed Phase (25 to 120 Hours Following Initiation of Cisplatin).
Time Frame: Delayed phase (25 to 120 hours following initiation of cisplatin).
The number of patients who reported No Vomiting and No Use of Rescue Therapy in the 25 to 120 hours following initiation of cisplatin chemotherapy.
Delayed phase (25 to 120 hours following initiation of cisplatin).
No Vomiting Overall (in the 120 Hours Following Initiation of Cisplatin)
Time Frame: Overall (the 120 hours following initiation of cisplatin chemotherapy)
The number of patients who reported No Vomiting in the 120 hours following initiation of cisplatin chemotherapy.
Overall (the 120 hours following initiation of cisplatin chemotherapy)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

January 28, 2008

First Submitted That Met QC Criteria

February 11, 2008

First Posted (Estimate)

February 21, 2008

Study Record Updates

Last Update Posted (Actual)

March 21, 2017

Last Update Submitted That Met QC Criteria

February 14, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0517-017
  • MK0517-017
  • 2007_594

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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