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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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 Corp.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chemotherapy-Induced Nausea and Vomiting (CINV) Drug: Comparator: fosaprepitant dimeglumine Drug: Comparator: Aprepitant Drug: Dexamethasone Drug: Ondansetron Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2322 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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 Start Date : February 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Arm 1: study medication
 Drug: Comparator: fosaprepitant dimeglumine
single IV dose of 150 mg of fosaprepitant dimeglumine on Day 1.

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: Ondansetron
single IV dose of 32 mg of ondansetron on Day 1.
Active Comparator: 2
Arm 2: Active comparator
 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, and 8 mg on Days 2-4.

Drug: Ondansetron
single IV dose of 32 mg of ondansetron on Day 1.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00619359


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Monitor Merck Sharp & Dohme Corp.
More Information
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Publications of Results:

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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00619359    
Other Study ID Numbers: 0517-017
MK0517-017
2007_594
First Posted: February 21, 2008    Key Record Dates
Results First Posted: February 12, 2010
Last Update Posted: March 21, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
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
Additional relevant MeSH terms:
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Nausea
Vomiting
Signs and Symptoms, Digestive
Dexamethasone
Dexamethasone acetate
Ondansetron
Aprepitant
Fosaprepitant
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
 Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Antipsychotic Agents
Tranquilizing Agents