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

Primary Purpose

Chemotherapy-Induced Nausea and Vomiting (CINV)

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Comparator: fosaprepitant dimeglumine

Comparator: Aprepitant

Dexamethasone

Ondansetron

About this trial

This is an interventional prevention trial for Chemotherapy-Induced Nausea and Vomiting (CINV)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Arm 1: study medication

Arm 2: Active comparator

Outcomes

Primary Outcome Measures

A Complete Response (no Vomiting and no Use of Rescue Therapy) Overall (in the 120 Hours Following Initiation of Cisplatin).

The number of patients who reported No Vomiting and No Use of Rescue Therapy in the 120 hours following initiation of cisplatin chemotherapy.

Secondary Outcome Measures

A Complete Response (no Vomiting and no Use of Rescue Therapy) in the 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.

No Vomiting Overall (in the 120 Hours Following Initiation of Cisplatin)

The number of patients who reported No Vomiting in the 120 hours following initiation of cisplatin chemotherapy.

Full Information

NCT ID

NCT00619359

First Posted

January 28, 2008

Last Updated

February 14, 2017

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT00619359

Brief Title

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

Acronym

EASE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

February 2008 (undefined)

Primary Completion Date

June 2009 (Actual)

Study Completion Date

June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chemotherapy-Induced Nausea and Vomiting (CINV)

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

2322 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Arm 1: study medication

Arm Title

Arm Type

Active Comparator

Arm Description

Arm 2: Active comparator

Intervention Type

Drug

Intervention Name(s)

Comparator: fosaprepitant dimeglumine

Intervention Description

single IV dose of 150 mg of fosaprepitant dimeglumine on Day 1.

Intervention Type

Drug

Intervention Name(s)

Comparator: Aprepitant

Intervention Description

Aprepitant 3-day dosing oral regimen (125 mg on Day 1 followed by 80 mg on Days 2 and 3).

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Intervention Description

Oral dose of 12 mg of dexamethasone on Day 1, and 8 mg on Days 2-4.

Intervention Type

Drug

Intervention Name(s)

Ondansetron

Intervention Description

single IV dose of 32 mg of ondansetron on Day 1.

Primary Outcome Measure Information:

Title

A Complete Response (no Vomiting and no Use of Rescue Therapy) Overall (in the 120 Hours Following Initiation of Cisplatin).

Description

The number of patients who reported No Vomiting and No Use of Rescue Therapy in the 120 hours following initiation of cisplatin chemotherapy.

Time Frame

Overall (in the 120 hours following initiation of cisplatin chemotherapy).

Secondary Outcome Measure Information:

Title

A Complete Response (no Vomiting and no Use of Rescue Therapy) in the Delayed Phase (25 to 120 Hours Following Initiation of Cisplatin).

Description

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.

Time Frame

Delayed phase (25 to 120 hours following initiation of cisplatin).

Title

No Vomiting Overall (in the 120 Hours Following Initiation of Cisplatin)

Description

The number of patients who reported No Vomiting in the 120 hours following initiation of cisplatin chemotherapy.

Time Frame

Overall (the 120 hours following initiation of cisplatin chemotherapy)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Monitor

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Citations:

PubMed Identifier

21383291

Citation

Grunberg S, Chua D, Maru A, Dinis J, DeVandry S, Boice JA, Hardwick JS, Beckford E, Taylor A, Carides A, Roila F, Herrstedt J. Single-dose fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting associated with cisplatin therapy: randomized, double-blind study protocol--EASE. J Clin Oncol. 2011 Apr 10;29(11):1495-501. doi: 10.1200/JCO.2010.31.7859. Epub 2011 Mar 7.

Results Reference

result

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

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