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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00619359
First received: January 28, 2008
Last updated: February 14, 2017
Last verified: February 2017

January 28, 2008
February 14, 2017
February 2008
June 2009   (Final data collection date for primary outcome measure)
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.
A Complete Response (no Vomiting and no Use of Rescue Therapy) Overall (in the 120 Hours Following Initiation of Cisplatin). [ Time Frame: in the 120 hours following initiation of cisplatin ]
Complete list of historical versions of study NCT00619359 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
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: 25 to 120 hours following initiation of cisplatin ]
Not Provided
Not Provided
 
Evaluation of Fosaprepitant (MK0517) in Single Dose Schedule (0517-017)
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Prevention
Chemotherapy-Induced Nausea and Vomiting (CINV)
  • Drug: Comparator: fosaprepitant dimeglumine
    single IV dose of 150 mg of fosaprepitant dimeglumine 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).
  • 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.
  • Experimental: 1
    Arm 1: study medication
    Interventions:
    • Drug: Comparator: fosaprepitant dimeglumine
    • Drug: Dexamethasone
    • Drug: Ondansetron
  • Active Comparator: 2
    Arm 2: Active comparator
    Interventions:
    • Drug: Comparator: Aprepitant
    • Drug: Dexamethasone
    • Drug: Ondansetron
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2322
June 2009
June 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Brazil,   Canada,   Chile,   Colombia,   Denmark,   Germany,   Guatemala,   Hong Kong,   Hungary,   India,   Italy,   Korea, Republic of,   Lithuania,   Mexico,   Netherlands,   New Zealand,   Panama,   Peru,   Poland,   Portugal,   Romania,   Russian Federation,   South Africa,   Spain,   Sweden,   United States,   Venezuela
 
NCT00619359
0517-017
MK0517-017
2007_594
Not Provided
Not Provided
Yes

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

Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP