Efficacy and Safety Study of Fosaprepitant (MK-0517) Plus Ondansetron Versus Ondansetron Alone for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Pediatric Participants (MK-0517-044)
Condition: Chemotherapy-induced Nausea and Vomiting
MeSH terms: Nausea; Vomiting
Intervention: Fosaprepitant; Placebo for fosaprepitant; Ondansetron; Dexamethasone; 5-HT3 antagonist
Intervention MeSH terms: Dexamethasone; Ondansetron; Fosaprepitant; Aprepitant; Serotonin 5-HT3 Receptor Antagonists
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 75.0
Sex: All
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy and safety of fosaprepitant (MK-0517)
      plus ondansetron versus ondansetron alone for the prevention of chemotherapy-induced nausea
      and vomiting (CINV) in pediatric participants scheduled to receive chemotherapeutic agent(s)
      associated with moderate or high risk of causing emesis (vomiting), or chemotherapy agent(s)
      not previously tolerated due to vomiting. The primary hypothesis is that a single dose of
      fosaprepitant in combination with ondansetron provides superior control of CINV compared to
      ondansetron alone as measured by the percentage of participants with a Complete Response (no
      vomiting, no retching, and no use of rescue medications) in the delayed phase (>24 to 120
      hours) following initiation of emetogneic chemotherapy in Cycle 1.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is 0 (at least 37 weeks gestation) to 17 years of age at time of randomization

          -  Has a Lansky Play Performance score ≥60 (participants ≤16 years of age) or a Karnofsky
             score ≥60 (participants >16 years of age)

          -  Has a predicted life expectancy ≥3 months

          -  Is receiving chemotherapeutic agent(s) associated with moderate or high risk of
             emetogenicity, or a chemotherapy regimen not previously tolerated due to vomiting

          -  Has a preexisting functional central venous catheter available for study drug
             administration

          -  Is male OR is female who is not of reproductive potential OR is female who is of
             reproductive potential and agrees to avoid becoming pregnant in the 28 days prior to
             receiving study drug, while receiving study drug and for at least 30 days after last
             dose of study drug

        Exclusion Criteria:

          -  Has vomited in the 24 hours prior to chemotherapy initiation on Treatment Day 1

          -  Has a symptomatic primary or metastatic central nervous system (CNS) malignancy with
             nausea and/or vomiting (asymptomatic participants may participate in study)

          -  Will be receiving stem cell rescue therapy in conjunction with study-related course of
             emetogenic chemotherapy or during the 14 days following administration of
             fosaprepitant/placebo for fosaprepitant

          -  Has received or will receive total body irradiation of radiation therapy to the
             abdomen or pelvis in the week prior to Treatment Day 1 and/or during the diary
             reporting period (120 hours following initiation of chemotherapy)

          -  Has had benzodiazepine, opioid or opioid like therapy initiated within 48 hours prior
             to study drug administration, or is expected to receive within 120 hours following
             initiation of chemotherapy except for single doses of midazolam, temazepam or
             triazolam

          -  Has started on systemic corticosteroid therapy within 72 hours prior to study drug
             administration or is expected to receive a corticosteroid as part of the chemotherapy
             regimen

          -  Is currently taking, or has taken within 48 hours of Treatment Day 1 the following
             drugs with antiemetic properties: 5-hydroxytryptamine 3 (5-HT3) antagonists (e.g.,
             ondansetron), benzamides (e.g., haloperidol), cyclizine, domperidone, herbal therapies
             with potential antiemetic properties, olanzapine, phenothiazines (e.g.,
             prochlorpenzine), scopolamine (this is not an exhaustive list)

          -  Is or has an immediate family member who is investigational site or sponsor staff
             directly involved with this study

          -  Is currently a user of any recreational or illicit drugs (including marijuana) or has
             current evidence of drug or alcohol abuse or dependence

          -  Is mentally incapacitated or has a significant emotional or psychiatric disorder

          -  Is pregnant or breast feeding

          -  Is allergic to fosaprepitant, aprepitant (MK-0869), ondansetron, or any other 5-HT3
             antagonist

          -  Has a known history of QT prolongation or is taking any medication that is known to
             lead to QT prolongation

          -  Has an active infection (e.g., pneumonia), congestive heart failure, bradyarrhythmia,
             any uncontrolled disease (e.g., diabetic ketoacidosis, gastrointestinal obstruction)
             except for malignancy

          -  Has ever participated in a previous study of aprepitant or fosaprepitant or has taken
             an investigational drug with the last 4 weeks.