Efficacy and Safety of Fosaprepitant Dimeglumine in Preventing Chemotherapy-Induced Nausea and Vomiting (MK-0517-031 AM4)

This study is currently recruiting participants.
Verified April 2014 by Merck Sharp & Dohme Corp.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01594749
First received: April 24, 2012
Last updated: April 17, 2014
Last verified: April 2014

April 24, 2012
April 17, 2014
September 2012
November 2014   (final data collection date for primary outcome measure)
  • Number of participants with Complete Response from 25 to 120 hours after initiation of MEC. [ Time Frame: 25 to 120 hours ] [ Designated as safety issue: No ]
  • Number of participants with infusion-site thrombophlebitis [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
  • Number of participants with severe infusion-site reactions, including site pain, or site redness (erythema) or site hardness (induration) [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
  • Number of participants with Complete Response from 25 to 120 hours after initiation of MEC. [ Time Frame: Day 2 to Day 6 ] [ Designated as safety issue: No ]
  • Number of participants with infusion-site thrombophlebitis [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
  • Number of participants with severe infusion-site reactions, including site pain, or erythema or induration [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01594749 on ClinicalTrials.gov Archive Site
  • Number of participants with Complete Response from 0 to 120 hours after initiation of MEC [ Time Frame: 0 to 120 hours ] [ Designated as safety issue: No ]
  • Number of participants with Complete Response from 0 to 24 hours after initiation of MEC [ Time Frame: 0 to 24 hours ] [ Designated as safety issue: No ]
  • Number of participants with No Vomiting from 0 to 120 hours after initiation of MEC [ Time Frame: 0 to 120 hours ] [ Designated as safety issue: No ]
  • Number of participants with Complete Response from 0 to 120 hours after initiation of MEC [ Time Frame: Day 1 to Day 6 ] [ Designated as safety issue: No ]
  • Number of participants with Complete Response from 0 to 24 hours after initiation of MEC [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Number of participants with No Vomiting from 0 to 120 hours after initiation of MEC [ Time Frame: Day 1 to Day 6 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Efficacy and Safety of Fosaprepitant Dimeglumine in Preventing Chemotherapy-Induced Nausea and Vomiting (MK-0517-031 AM4)
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

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 and corticosteroid only, in preventing chemotherapy-induced nausea and vomiting (CINV) associated with moderately emetogenic chemotherapy (MEC).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Chemotherapy-Induced Nausea and Vomiting
  • 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
  • Experimental: Fosaprepitant IV

    Fosaprepitant dimeglumine: Single 150 mg dose intravenously, approximately (~) 30 minutes prior to chemotherapy on Day 1

    Dexamethasone 12 mg: orally (po) on Day 1, ~30 minutes prior to chemotherapy

    Ondansetron 16 mg: 8 mg po, ~30-60 minutes prior to chemotherapy, followed by 8 mg po, 8 hours after first dose for a total dose of 16 mg on Day 1.

    Dexamethasone Placebo: po, ~30 minutes prior to chemotherapy on Day 1

    Ondansetron Placebo: po every 12 hours, on Days 2 and 3

    Rescue Therapy: For established cases of nausea or vomiting, medications may be prescribed at the investigator's discretion from the following list of 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 Therapy

    Fosaprepitant Placebo: Fosaprepitant placebo in the form of 150 mL of 0.9% normal saline intravenously, ~30 minutes hour prior to chemotherapy on Day 1

    Dexamethasone 20 mg: po, ~30 minutes prior to chemotherapy on Day 1

    Ondansetron 16 mg: Day 1 - 8 mg orally, ~30-60 minutes prior to chemotherapy; followed by 8 mg orally, 8 hours after the first dose for a total daily dose of 16 mg. Days 2-3 - 8 mg orally every 12 hours.

    Rescue Therapy: For established cases of nausea or vomiting, medications may be prescribed at the investigator's discretion from the following list of 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
990
November 2014
November 2014   (final data collection date for primary outcome measure)

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 (AC MEC)
  • Has a predicted life expectancy of at least 4 months, and a Karnofsky score of at least 60 indicating that the subject 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 medication

Exclusion Criteria:

  • Has vomited in the 24 hours prior to treatment Day 1
  • Has symptomatic primary or metastatic symptomatic central nervous system (CNS) malignancy causing nausea and/or vomiting
  • Is scheduled to receive chemotherapy agent classified as highly emetogenic
  • Has received or will receive total body irradiation (TBI), 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 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
  • Takes other excluded medication
Both
18 Years and older
No
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NCT01594749
0517-031
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
April 2014

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