Study of the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Fosaprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Children (MK-0517-029)
Condition: Chemotherapy-induced Nausea and Vomiting
MeSH terms: Nausea; Vomiting
Intervention: Fosaprepitant; Fosaprepitant Placebo; Ondansetron; 5-hydroxytryptamine 3 antagonist
Intervention description: Administered intravenously (IV) as a single dose; Administered IV as a single dose; Administered IV according to local labeling and/or local standard of care; Administered IV according to local labeling and/or local standard of care
Intervention MeSH terms: Ondansetron; Fosaprepitant; Aprepitant; Serotonin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 240.0
Sex: All
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of this study was to determine the appropriate dosing regimen of fosaprepitant,
      when administered with ondansetron (with or without dexamethasone), for the prevention of
      CINV in children from birth to <17 years of age. Fosaprepitant is a prodrug to aprepitant.
      All participants who completed the randomized Cycle 1 could elect to receive open-label
      fosaprepitant during optional Cycles 2-6.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is 0 months (at least 37 weeks gestation) to <18 years of age

          -  Scheduled to receive chemotherapeutic agent(s) associated with moderate, high, or very
             high risk of emetogenicity for no more than 5 consecutive days for a documented
             malignancy, or a chemotherapy regimen not previously tolerated due to vomiting

          -  Expected to receive ondansetron as part of antiemetic regimen (Cycle 1); Expected to
             receive a 5-HT3 antagonist as part of antiemetic regimen (Cycles 2-6)

          -  If female and has begun menstruating, must have a negative pregnancy test prior to
             study participation and agree to remain abstinent or use a barrier form of
             contraception

          -  Predicted life expectancy of ≥3 months

          -  Pre-existing functioning central venous catheter

          -  Weight ≥3rd percentile for age and gender (and ≥3.0 kg)

        Exclusion Criteria:

          -  Vomited in the 24 hours prior study drug administration (Cycle 1)

          -  Current user of any illicit drugs (including marijuana) or current evidence of alcohol
             abuse

          -  Scheduled to receive stem cell rescue therapy in conjunction with study related
             course(s) of emetogenic chemotherapy

          -  Received or will receive radiation therapy to the abdomen or pelvis in the week prior
             to study drug administration and/or during the course of the study

          -  Pregnant or breast feeding

          -  Allergic to fosaprepitant, aprepitant, ondansetron, or any other 5-HT3 antagonist

          -  Has a symptomatic central nervous system (CNS) tumor causing nausea and/or vomiting

          -  Has an active infection, congestive heart failure, slow heart rate, or other
             uncontrolled disease other than cancer

          -  Mentally incapacitated or has a significant emotional or psychiatric disorder

          -  Known history of QT prolongation or is taking any medication known to lead to QT
             prolongation

          -  Taking other excluded medications

          -  Participated in any previous study of aprepitant or fosaprepitant, or taken an
             investigational drug within 4 weeks prior to study participation