Safety of a Three-Day Fosaprepitant Regimen for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Pediatric Participants (MK-0517-045)
Condition: Chemotherapy-induced Nausea and Vomiting
MeSH terms: Nausea; Vomiting
Intervention: Fosaprepitant Dimeglumine; 5-HT3 antagonist; Dexamethasone
Intervention description: Participants received IV fosaprepitant dimeglumine ≤115 mg on Day 1 and ≤80 mg on Days 2 and 3 (dose adjusted for age).; All participants received an oral 5-hydroxytryptamine (serotonin; [5-HT]) 3 receptor antagonist on Day 1 and had the option to take on Days 2-3. The dose was as per product label or standard of care.; Participants received optional oral dexamethasone at the investigator's discretion according to product label or standard of care.
Intervention MeSH terms: Dexamethasone; Fosaprepitant; Aprepitant; Serotonin 5-HT3 Receptor Antagonists
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 103.0
Sex: All
Minimum age: 6 Months
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and tolerability of a 3-day intravenous
      (IV) fosaprepitant dimeglumine (MK-0517) regimen for the prevention of CINV in pediatric
      participants scheduled to receive emetogenic chemotherapy. Each participant was enrolled in
      Cycle 1 (on which the primary study objectives were based), consisting of the 3-day treatment
      cycle and 14 days of follow-up for a total of 17 days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is receiving a moderately or highly emetogenic chemotherapy agent/regimen or a
             chemotherapy agent/regimen not previously tolerated due to vomiting

          -  Has a Lansky Play Performance score ≥60 (participants ≤16 years of age) or a Karnofsky
             score ≥60 (participants >16 years of age)

          -  Has a pre-existing functional central venous catheter available for study treatment
             administration

          -  Is fosaprepitant naïve

          -  Has a predicted life expectancy ≥3 months

          -  A female participant is eligible to participate if she is not pregnant or
             breastfeeding, and at least one of the following conditions applies: is not a woman of
             childbearing potential (WOCBP) OR is a WOCBP and agrees to not be sexually active or
             use a highly effective contraceptive method for at least 28 days prior to receiving
             study treatment, during the treatment period, and for at least 30 days (or local
             standard of care if longer) after the last dose of study treatment (including the
             optional cycles)

          -  Has a negative highly sensitive pregnancy test (urine or serum as required by local
             regulations) prior to the start of fosaprepitant administration in a given cycle if a
             WOCBP

          -  Weighs at least 6 kilograms (kg)

        Exclusion Criteria:

          -  Will receive stem cell rescue therapy in conjunction with a study-related course of
             emetogenic chemotherapy or during the 14 days following administration of
             fosaprepitant

          -  Is currently a user of any recreational or illicit drugs or has current evidence of
             drug or alcohol abuse or dependence as determined by the investigator

          -  Is mentally incapacitated or has a significant emotional or psychiatric disorder that,
             in the opinion of the investigator, precludes study entry

          -  Is pregnant or breast feeding

          -  Is allergic to fosaprepitant, aprepitant, or prescribed 5-HT3 antagonist

          -  Has an active infection (eg, pneumonia), congestive heart failure, bradyarrhythmia,
             any uncontrolled disease (eg, diabetic ketoacidosis, gastrointestinal obstruction)
             except for malignancy, or has any illness which in the opinion of the investigator,
             might confound the results of the study or pose unwarranted risk in administering
             study treatment or concomitant therapy to the participant

          -  Is a WOCBP who has a positive pregnancy test at screening (Cycle 1) or on Day 1 of
             optional Cycles 2 or 3

          -  Has been started on systemic corticosteroid therapy within 72 hours prior to study
             treatment administration or is expected to receive a corticosteroid as part of the
             chemotherapy regimen. Exceptions apply

          -  Is taking excluded medications

          -  Has ever participated in a previous study of aprepitant or fosaprepitant or has taken
             a non-approved (investigational) drug within the last 4 weeks

          -  Has a known history of QT prolongation or is taking any medication that is known to
             lead to QT prolongation