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

NCT ID: NCT00619359

Last Updated: 2017-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 2322 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2009-06-30

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.

Conditions

Chemotherapy-Induced Nausea and Vomiting (CINV)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

1

Arm 1: study medication

Group Type: EXPERIMENTAL

Comparator: fosaprepitant dimeglumine

Intervention Type: DRUG

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

Dexamethasone

Intervention Type: DRUG

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.

Ondansetron

Intervention Type: DRUG

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

2

Arm 2: Active comparator

Group Type: ACTIVE_COMPARATOR

Comparator: Aprepitant

Intervention Type: DRUG

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

Dexamethasone

Intervention Type: DRUG

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

Ondansetron

Intervention Type: DRUG

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

Interventions

Comparator: fosaprepitant dimeglumine

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

Intervention Type: DRUG

Comparator: Aprepitant

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

Intervention Type: 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.

Intervention Type: DRUG

Dexamethasone

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

Intervention Type: DRUG

Ondansetron

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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.

Reference Type: RESULT

PMID: 21383291 (View on PubMed)

Other Identifiers

MK0517-017

Identifier Type: -

Identifier Source: secondary_id

2007_594

Identifier Type: -

Identifier Source: secondary_id

0517-017

Identifier Type: -

Identifier Source: org_study_id