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

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ClinicalTrials.gov Identifier: NCT00619359
Recruitment Status : Completed
First Posted : February 21, 2008
Results First Posted : February 12, 2010
Last Update Posted : March 21, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Tracking Information
First Submitted Date  ICMJE January 28, 2008
First Posted Date  ICMJE February 21, 2008
Results First Submitted Date  ICMJE January 19, 2010
Results First Posted Date  ICMJE February 12, 2010
Last Update Posted Date March 21, 2017
Study Start Date  ICMJE February 2008
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 19, 2010)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 11, 2008)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 19, 2010)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2008)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Fosaprepitant (MK0517) in Single Dose Schedule (0517-017)
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Chemotherapy-Induced Nausea and Vomiting (CINV)
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 19, 2010)
2322
Original Estimated Enrollment  ICMJE
 (submitted: February 11, 2008)
2292
Actual Study Completion Date  ICMJE June 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries 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
 
Administrative Information
NCT Number  ICMJE NCT00619359
Other Study ID Numbers  ICMJE 0517-017
MK0517-017
2007_594
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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

Current Responsible Party Merck Sharp & Dohme LLC
Original Responsible Party Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
Current Study Sponsor  ICMJE Merck Sharp & Dohme LLC
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Merck Sharp & Dohme LLC
PRS Account Merck Sharp & Dohme LLC
Verification Date February 2017

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