Efficacy and Safety of Fosaprepitant Dimeglumine in Preventing Chemotherapy-Induced Nausea and Vomiting (MK-0517-031)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01594749
First received: April 24, 2012
Last updated: November 2, 2015
Last verified: November 2015
Results First Received: August 26, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Condition: Chemotherapy-Induced Nausea and Vomiting (CINV)
Interventions: Drug: Fosaprepitant dimeglumine
Drug: Fosaprepitant Placebo
Drug: Dexamethasone
Drug: Ondansetron
Drug: Dexamethasone Placebo
Drug: Ondansetron Placebo
Drug: Rescue Therapy

  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
A total of 14 participants did not receive any study drug: 4 in the Fosaprepitant Regimen and 10 in the Control Regimen. One participant who was randomized to the Control Regimen received the Fosaprepitant Regimen.

Reporting Groups
  Description
Fosaprepitant Regimen On Day 1, participants received fosaprepitant, 150 mg intravenous (IV) infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 12 mg, orally (PO) ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy, followed by 8 mg PO, 8 hours after first dose PLUS dexamethasone placebo, PO ~30 minutes prior to chemotherapy. On Days 2 and 3, participants received ondansetron placebo, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-hydroxytryptamine 3 (5-HT3) antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
Control Regimen On Day 1, participants received fosaprepitant placebo, 150 mL IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 20 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy; followed by 8 mg PO, 8 hours after the first dose. On Days 2-3, participants received ondansetron 8 mg, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.

Participant Flow:   Overall Study
    Fosaprepitant Regimen     Control Regimen  
STARTED     507     508  
Treated     503     498  
COMPLETED     485     490  
NOT COMPLETED     22     18  
Adverse Event                 2                 1  
Withdrawal by Subject                 2                 2  
Protocol Violation                 2                 0  
Physician Decision                 1                 1  
Non-compliance with Protocol                 0                 1  
Lost to Follow-up                 1                 0  
Death                 9                 3  
Not Treated                 4                 10  
Lost Source Documentation                 1                 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.
The Baseline analysis population is consistent with the Intent-to-Treat (ITT) population, i.e., all randomized participants who received ≥1 dose of study drug within the assigned treatment regimen. Note: One participant with missing source documentation in the Fosaprepitant Regimen was excluded from the ITT population.

Reporting Groups
  Description
Fosaprepitant Regimen On Day 1, participants received fosaprepitant, 150 mg IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 12 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy, followed by 8 mg PO, 8 hours after first dose PLUS dexamethasone placebo, PO ~30 minutes prior to chemotherapy. On Days 2 and 3, participants received ondansetron placebo, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
Control Regimen On Day 1, participants received fosaprepitant placebo, 150 mL IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 20 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy; followed by 8 mg PO, 8 hours after the first dose. On Days 2-3, participants received ondansetron 8 mg, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
Total Total of all reporting groups

Baseline Measures
    Fosaprepitant Regimen     Control Regimen     Total  
Number of Participants  
[units: participants]
  502     498     1000  
Age  
[units: Years]
Mean (Standard Deviation)
  60.0  (11.8)     59.1  (12.3)     59.6  (12.1)  
Gender  
[units: Participants]
     
Female     298     293     591  
Male     204     205     409  



  Outcome Measures
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1.  Primary:   Percentage of Participants With Complete Response From 25 to 120 Hours After Initiation of Moderately Emetogenic Chemotherapy (MEC)   [ Time Frame: 25 to 120 hours after initiation of MEC ]

2.  Primary:   Percentage of Participants With Infusion-site Thrombophlebitis   [ Time Frame: Day 1 through Day 17, inclusive ]

3.  Primary:   Percentage of Participants With Severe Infusion-site Reactions   [ Time Frame: Day 1 through Day 17, inclusive ]

4.  Secondary:   Percentage of Participants With Complete Response From 0 to 120 Hours After Initiation of MEC   [ Time Frame: 0 to 120 hours after initiation of MEC ]

5.  Secondary:   Percentage of Participants With Complete Response From 0 to 24 Hours After Initiation of MEC   [ Time Frame: 0 to 24 hours after initiation of MEC ]

6.  Secondary:   Percentage of Participants With No Vomiting From 0 to 120 Hours After Initiation of MEC   [ Time Frame: 0 to 120 hours after initiation of MEC ]


  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


Publications of Results:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01594749     History of Changes
Other Study ID Numbers: 0517-031
Study First Received: April 24, 2012
Results First Received: August 26, 2015
Last Updated: November 2, 2015
Health Authority: United States: Food and Drug Administration