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Fosaprepitant (MK-0517, EMEND® IV) In Salvage Treatment of Chemotherapy-Induced Vomiting (MK-0517-030) (EVADE)

This study has been terminated.
(Low enrollment)
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01405924
First received: July 28, 2011
Last updated: October 24, 2014
Last verified: October 2014
Results First Received: October 24, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Nausea
Vomiting
Interventions: Drug: Fosaprepitant dimeglumine
Drug: 5-HT3 RA
Drug: Dexamethasone
Drug: Rescue medication

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Fosaprepitant 150 mg Women with breast cancer receiving anthracycline-cyclophosphamide (AC)-like chemotherapy and women with gynecological cancer receiving carboplatin-paclitaxel (CT) chemotherapy receive fosaprepitant 150 mg administered intravenously (IV) on Day 1 of Cycle 2 of chemotherapy

Participant Flow:   Overall Study
    Fosaprepitant 150 mg  
STARTED     111  
COMPLETED     101  
NOT COMPLETED     10  
Protocol Violation                 8  
Missing/Incomplete Data                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Fosaprepitant 150 mg Women with breast cancer receiving AC-like chemotherapy and women with gynecological cancer receiving CT chemotherapy receive fosaprepitant 150 mg administered IV on Day 1 of Cycle 2 of chemotherapy

Baseline Measures
    Fosaprepitant 150 mg  
Number of Participants  
[units: participants]
  111  
Age  
[units: Years]
Mean ± Standard Deviation
  52.83  ± 12.60  
Gender  
[units: Participants]
 
Female     111  
Male     0  



  Outcome Measures
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1.  Primary:   Percentage of Participants With No Vomiting and No Retching During Cycle 2 of Chemotherapy   [ Time Frame: Up to 120 hours following initiation of chemotherapy in Cycle 2 ]

2.  Secondary:   Percentage of Participants With No Vomiting and No Retching During Cycle 2 of Chemotherapy Per Type of Chemotherapy   [ Time Frame: Up to 120 hours following initiation of chemotherapy in Cycle 2 ]

3.  Secondary:   Percentage of Participants With a Complete Response During Cycle 2 of Chemotherapy   [ Time Frame: Up to 120 hours following initiation of chemotherapy in Cycle 2 ]

4.  Secondary:   Functional Living Index - Emesis (FLIE) Total Score During Cycle 2 of Chemotherapy   [ Time Frame: From Day 1 (prior to initiation of chemotherapy in Cycle 2) to morning of Day 6 (up to ~120 hours following initiation of chemotherapy in Cycle 2) ]

5.  Secondary:   Percentage of Participants With No Significant Nausea During Cycle 2 of Chemotherapy   [ Time Frame: From 24 to 120 hours following initiation of chemotherapy in Cycle 2 ]

6.  Secondary:   Percentage of Participants Who Used No Rescue Medication During Cycle 2 of Chemotherapy   [ Time Frame: Up to 120 hours following initiation of chemotherapy in Cycle 2 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01405924     History of Changes
Other Study ID Numbers: 0517-030
Study First Received: July 28, 2011
Results First Received: October 24, 2014
Last Updated: October 24, 2014
Health Authority: Canada: Health Canada