Efficacy and Safety of Fosaprepitant Dimeglumine in Preventing Chemotherapy-Induced Nausea and Vomiting (MK-0517-031)
Condition: Chemotherapy-Induced Nausea and Vomiting (CINV)
MeSH terms: Nausea; Vomiting
Intervention: Fosaprepitant dimeglumine; Fosaprepitant Placebo; Dexamethasone; Ondansetron; Dexamethasone Placebo; Ondansetron Placebo; Rescue Therapy
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Ondansetron; Fosaprepitant; Aprepitant; BB 1101
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1015.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: NK-1 Receptor Antagonist, CINV, Emesis, MEC

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).
    

Eligibility criteria:

        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.