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OpenTrials
Completed

NCT Number: NCT00619359

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comparator: fosaprepitant dimeglumine

Drug

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

Comparator: Aprepitant

Drug

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

Dexamethasone

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

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Acronym: EASE

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Feb 21, 2008
Registry last updated
Mar 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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