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

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ClinicalTrials.gov Identifier: NCT01594749
Recruitment Status : Completed
First Posted : May 9, 2012
Results First Posted : September 25, 2015
Last Update Posted : September 4, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE April 24, 2012
First Posted Date  ICMJE May 9, 2012
Results First Submitted Date  ICMJE August 26, 2015
Results First Posted Date  ICMJE September 25, 2015
Last Update Posted Date September 4, 2018
Actual Study Start Date  ICMJE September 24, 2012
Actual Primary Completion Date November 3, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 26, 2015)
  • 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 ]
    A Complete Response was defined as no vomiting and no use of rescue medication.
  • Percentage of Participants With Infusion-site Thrombophlebitis [ Time Frame: Day 1 through Day 17, inclusive ]
    The percentages of participants with infusion-site thrombophlebitis are presented. Thrombophlebitis was defined as a condition affecting a superficial vein used for an IV infusion, associated with red color, hardness upon palpation, and the presence of a tender cord and possible fever.
  • Percentage of Participants With Severe Infusion-site Reactions [ Time Frame: Day 1 through Day 17, inclusive ]
    The percentages of participants with severe infusion-site reactions, including severe site pain, or severe site redness (erythema) or severe site hardness (induration) are presented.
Original Primary Outcome Measures  ICMJE
 (submitted: May 7, 2012)
  • Number of participants with Complete Response from 25 to 120 hours after initiation of MEC. [ Time Frame: Day 2 to Day 6 ]
  • Number of participants with infusion-site thrombophlebitis [ Time Frame: Day 1 ]
  • Number of participants with severe infusion-site reactions, including site pain, or erythema or induration [ Time Frame: Day 1 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 26, 2015)
  • 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 ]
    A Complete Response was defined as no vomiting and no use of rescue medication.
  • 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 ]
    A Complete Response was defined as no vomiting and no use of rescue medication.
  • 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 ]
    No Vomiting was defined as no emetic (vomiting) episodes, including no vomiting and no retching or dry heaves (attempts to vomit that are not productive of stomach contents), regardless of use of rescue medication.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2012)
  • Number of participants with Complete Response from 0 to 120 hours after initiation of MEC [ Time Frame: Day 1 to Day 6 ]
  • Number of participants with Complete Response from 0 to 24 hours after initiation of MEC [ Time Frame: Day 1 ]
  • Number of participants with No Vomiting from 0 to 120 hours after initiation of MEC [ Time Frame: Day 1 to Day 6 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Fosaprepitant Dimeglumine in Preventing Chemotherapy-Induced Nausea and Vomiting (MK-0517-031)
Official Title  ICMJE A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Parallel-Group Study, Conducted Under In-House Blinding Conditions, to Examine the Efficacy and Safety of a Single 150 mg Dose of Intravenous Fosaprepitant Dimeglumine for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) Associated With Moderately Emetogenic Chemotherapy
Brief Summary This study aims to demonstrate that, when given concomitantly with a 5-hydroxytryptamine 3 (5-HT3) antagonist and a corticosteroid, a single 150 mg intravenous (IV) dose of fosaprepitant given on Day 1 is superior to the control regimen of 5-HT3 antagonist and corticosteroid only, in preventing chemotherapy-induced nausea and vomiting (CINV) associated with moderately emetogenic chemotherapy (MEC).
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: Fosaprepitant dimeglumine
    Other Names:
    • EMEND for Injection
    • MK-0517
  • Drug: Fosaprepitant Placebo
  • Drug: Dexamethasone
    Other Name: Decadron
  • Drug: Ondansetron
    Other Name: Zofran
  • Drug: Dexamethasone Placebo
  • Drug: Ondansetron Placebo
  • Drug: Rescue Therapy
Study Arms  ICMJE
  • Experimental: 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-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.
    Interventions:
    • Drug: Fosaprepitant dimeglumine
    • Drug: Dexamethasone
    • Drug: Ondansetron
    • Drug: Dexamethasone Placebo
    • Drug: Ondansetron Placebo
    • Drug: Rescue Therapy
  • Active Comparator: 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.
    Interventions:
    • Drug: Fosaprepitant Placebo
    • Drug: Dexamethasone
    • Drug: Ondansetron
    • Drug: Rescue Therapy
Publications *

*   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: November 7, 2014)
1015
Original Estimated Enrollment  ICMJE
 (submitted: May 7, 2012)
990
Actual Study Completion Date  ICMJE November 3, 2014
Actual Primary Completion Date November 3, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Has a histologically or cytologically confirmed malignant disease
  • Is naive to moderately and highly emetogenic chemotherapy
  • Is scheduled to receive a single IV dose of one or more MEC agents on Day 1, except for the combination of anthracycline and cyclophosphamide
  • Has a predicted life expectancy of at least 4 months, and a Karnofsky score of at least 60 indicating that the participant requires occasional assistance, but is able to care for most of his/her needs.
  • Female of childbearing potential demonstrates a negative urine pregnancy test, and agrees to remain abstinent or use two acceptable forms of birth control for at least 14 days prior to study, throughout the study, and at least 1 month following last dose of study drug.

Exclusion Criteria:

  • Has vomited in the 24 hours prior to treatment Day 1
  • Has symptomatic primary or metastatic symptomatic central nervous system malignancy causing nausea and/or vomiting
  • Is scheduled to receive chemotherapy agent classified as highly emetogenic
  • Has received or will receive total body irradiation, or radiation therapy to the abdomen, pelvis, head and neck in the week prior to Treatment Days 1 through Day 6 of the Treatment Period
  • Has illness or history of illness which might confound study results or pose unwarranted risk
  • Known history of QT interval prolongation
  • Uses illicit drugs or abuses alcohol
  • Mentally incapacitated or has a significant emotional or psychiatric disorder
  • History of hypersensitivity to aprepitant, ondansetron or dexamethasone
  • Pregnant or breast-feeding
  • Has participated in a study with aprepitant or taken a non-approved (investigational) drug within the last 4 weeks
  • Has concurrent condition, such as systemic fungal infection or uncontrolled diabetes, that precludes administration of dexamethasone.
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 Argentina,   Bulgaria,   Canada,   Chile,   Colombia,   Croatia,   Czech Republic,   Finland,   Germany,   Greece,   Hungary,   Italy,   Latvia,   Mexico,   Netherlands,   Norway,   Peru,   Philippines,   Poland,   Portugal,   Puerto Rico,   Romania,   Russian Federation,   South Africa,   Spain,   Sweden,   Thailand,   Turkey,   Ukraine,   United States
 
Administrative Information
NCT Number  ICMJE NCT01594749
Other Study ID Numbers  ICMJE 0517-031
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date August 2018

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