A Study of the Safety and Efficacy of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Pediatric Participants (MK-0869-208)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01362530
First received: May 26, 2011
Last updated: February 24, 2014
Last verified: February 2014
Results First Received: February 24, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Prevention
Condition: Chemotherapy Induced Nausea and Vomiting
Interventions: Drug: Aprepitant 125 mg
Drug: Aprepitant 80 mg
Drug: Aprepitant powder for suspension (PFS)
Drug: Ondansetron
Drug: Placebo for Aprepitant 125 mg
Drug: Placebo for Aprepitant 80 mg
Drug: Placebo for Aprepitant PFS

  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
The base study consisted of once cycle of treatment (Cycle 1). Participants in either treatment group who met the eligibility criteria were eligible to participate in optional open-label aprepitant treatment for an additional 5 cycles (Cycles 2-6).

Reporting Groups
  Description
Aprepitant Regimen Cycle 1: Participants 12 to 17 years of age, Day 1: aprepitant 125 mg capsule orally (PO) + ondansetron, Days 2 to 3: aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: aprepitant powder for suspension (PFS), 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: aprepitant PFS, 2.0 mg/kg (up to 80 mg). Optional Cycles 2-6: Open-label aprepitant administered in the same manner as in Cycle 1.
Control Regimen Cycle 1: Participants 12 to 17 years of age, Day 1: matching placebo for aprepitant 125 mg capsule oral (PO) + ondansetron Days 2 to 3: matching placebo for aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: matching placebo PFS: 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: matching placebo PFS: 2.0 mg/kg (up to 80 mg). Optional Cycles 2-6: Open-label aprepitant administered in the same manner as in Cycle 1.

Participant Flow for 2 periods

Period 1:   Base Study (Cycle 1)
    Aprepitant Regimen     Control Regimen  
STARTED     155     152  
Received Study Treatment     152     150  
COMPLETED     150     149  
NOT COMPLETED     5     3  
Adverse Event                 2                 0  
Physician Decision                 0                 1  
Protocol Violation                 2                 0  
Withdrawal by Subject                 1                 2  

Period 2:   Optional Extension (Cycles 2-6)
    Aprepitant Regimen     Control Regimen  
STARTED     171     0  
COMPLETED     46     0  
NOT COMPLETED     125     0  
Adverse Event                 2                 0  
Completed Chemotherapy Regimen                 51                 0  
Did Not Meet Additional Criteria                 25                 0  
Did Not Respond To Chemotherapy Regimen                 4                 0  
Lack of Efficacy                 1                 0  
Lost to Follow-up                 1                 0  
Physician Decision                 19                 0  
Protocol Violation                 4                 0  
Withdrawal by Subject                 18                 0  



  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.
Intent-to-treat (ITT) population: all randomized participants who received study medication.

Reporting Groups
  Description
Aprepitant Regimen Cycle 1: Participants 12 to 17 years of age, Day 1: aprepitant 125 mg capsule orally (PO) + ondansetron, Days 2 to 3: aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: aprepitant powder for suspension (PFS), 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: aprepitant PFS, 2.0 mg/kg (up to 80 mg). Optional Cycles 2-6: Open-label aprepitant administered in the same manner as in Cycle 1.
Control Regimen Cycle 1: Participants 12 to 17 years of age, Day 1: matching placebo for aprepitant 125 mg capsule oral (PO) + ondansetron Days 2 to 3: matching placebo for aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: matching placebo PFS: 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: matching placebo PFS: 2.0 mg/kg (up to 80 mg). Optional Cycles 2-6: Open-label aprepitant administered in the same manner as in Cycle 1.
Total Total of all reporting groups

Baseline Measures
    Aprepitant Regimen     Control Regimen     Total  
Number of Participants  
[units: participants]
  152     150     302  
Age  
[units: Months]
Mean ± Standard Deviation
  97.7  ± 63.2     99.4  ± 60.9     98.5  ± 62.0  
Gender  
[units: Participants]
     
Female     68     71     139  
Male     84     79     163  



  Outcome Measures
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1.  Primary:   Percentage of Participants With a Complete Response in the Delayed Phase of Cycle 1   [ Time Frame: 25 to 120 hours after the start of chemotherapy ]

2.  Secondary:   Percentage of Participants With a Complete Response in the Acute Phase of Cycle 1   [ Time Frame: 0 to 24 hours after initiation of chemotherapy ]

3.  Secondary:   Percentage of Participants With a Complete Response in the Overall Phase of Cycle 1   [ Time Frame: 0 to 120 hours after initiation of chemotherapy ]

4.  Secondary:   Percentage of Participants With No Vomiting in the Overall Phase of Cycle 1   [ Time Frame: 0 to 120 hours after initiation of chemotherapy ]


  Serious Adverse Events


  Other Adverse Events


  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.


Limitations and Caveats
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
No text entered.  


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: NCT01362530     History of Changes
Other Study ID Numbers: 0869-208
Study First Received: May 26, 2011
Results First Received: February 24, 2014
Last Updated: February 24, 2014
Health Authority: United States: Food and Drug Administration