A Study of the Safety and Efficacy of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Pediatric Participants (MK-0869-208 AM3)

• Percentage of Participants with a Complete Response (Intent-to-Treat Population) [ Time Frame: Up to 24 hours after initiation of chemotherapy ] [ Designated as safety issue: No ]
• Percentage of Participants with a Complete Response (Intent-to-Treat Population) [ Time Frame: Up to 120 hours after initiation of chemotherapy ] [ Designated as safety issue: No ]
• Percentage of Participants with No Vomiting (Intent-to-Treat Population) [ Time Frame: Up to 120 hours after initiation of chemotherapy ] [ Designated as safety issue: No ]

This study will compare the safety and efficacy of a three-day oral aprepitant regimen (aprepitant plus ondansetron) to ondansetron alone in the prevention of chemotherapy-induced nausea and vomiting (CINV) in the 120 hours following the initiation of chemotherapy in pediatric participants.

• Drug: Aprepitant 125 mg
  On the morning of Day 1: one 125 mg capsule PO 60 minutes prior to chemotherapy for participants 12 to 17 years of age
  Other Name: MK-0869, Emend®
• Drug: Aprepitant 80 mg
  On the morning of Days 2 and 3: one 80 mg capsule PO for participants 12 to 17 years of age
  Other Name: MK-0869, Emend®
• Drug: Aprepitant powder for suspension (PFS)
  On the morning of Day 1: 3.0 mg/kg (up to 125 mg) PO 60 minutes prior to chemotherapy for participants 6 months to <12 years of age. On the morning of Days 2 and 3: 2.0 mg/kg (up to 80 mg) PO 60 minutes prior to chemotherapy (if applicable) for participants 6 months to <12 years of age
  Other Name: MK-0869, Emend®
• Drug: Ondansetron
  Day 1: Administered according to product label for pediatric usage or local standard of care
  Other Name: Zofran™
• Drug: Placebo for Aprepitant 125 mg
  On the morning of Day 1: one 125 mg capsule PO 60 minutes prior to chemotherapy for participants 12 to 17 years of age
• Drug: Placebo for Aprepitant 80 mg
  On the morning of Days 2 and 3: one 80 mg capsule PO for participants 12 to 17 years of age
• Drug: Placebo for Aprepitant PFS
  On the morning of Day 1: 3.0 mg/kg (up to 125 mg) PO 60 minutes prior to chemotherapy for participants 6 months to <12 years of age. On the morning of Days 2 and 3: 2.0 mg/kg (up to 80 mg) PO 60 minutes prior to chemotherapy (if applicable) for participants 6 months to <12 years of age

• Experimental: Aprepitant Regimen
  Participants 12 to 17 years of age, Day 1: aprepitant 125 mg capsule orally (PO) + ondansetron, Days 2 to 3: aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: aprepitant powder for suspension (PFS), 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: aprepitant PFS, 2.0 mg/kg (up to 80 mg).
  Interventions:

  • Drug: Aprepitant 125 mg
  • Drug: Aprepitant 80 mg
  • Drug: Aprepitant powder for suspension (PFS)
  • Drug: Ondansetron
• Placebo Comparator: Control Regimen
  Participants 12 to 17 years of age, Day 1: matching placebo for aprepitant 125 mg capsule oral (PO) + ondansetron Days 2 to 3: matching placebo for aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: matching placebo PFS: 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: matching placebo PFS: 2.0 mg/kg (up to 80 mg).
  Interventions:

  • Drug: Ondansetron
  • Drug: Placebo for Aprepitant 125 mg
  • Drug: Placebo for Aprepitant 80 mg
  • Drug: Placebo for Aprepitant PFS

Inclusion Criteria:

• Is 6 months to 17 years of age at time of study entry
• Is scheduled to receive chemotherapeutic agent(s) associated with moderate, high risk or very high risk of vomiting for a documented malignancy, or a chemotherapy regimen not previously tolerated due to vomiting
• Is expected to receive ondansetron as part of their antiemetic regimen
• If female and has begun menses, must has a negative urine pregnancy test prior to randomization. A female who is of reproductive potential agrees to remain abstinent or use a barrier form of contraception for at least 14 days prior to, throughout, and for at least one month following the last dose of study medication
• If >10 years old, have a Karnofsky score ≥ 60; if ≤ 10 years have a Lansky Play Performance score ≥ 60
• Have a predicted life expectancy of ≥ 3 months

Exclusion Criteria:

• Has vomited in the 24 hours prior to Treatment Day 1
• Is scheduled to receive stem cell rescue therapy in conjunction with study related course(s) of emetogenic chemotherapy
• Has received or will receive radiation therapy to the abdomen or pelvis within a week prior to Treatment Day 1 or during the course of the study
• Is pregnant or breast feeding
• Is allergic to aprepitant, ondansetron, or any other 5-hydroxytryptamine type-3 receptor (5-HT3) antagonist
• Has a symptomatic primary or metastatic CNS malignancy causing nausea and/or vomiting
• History of QT prolongation or taking other medicinal products that lead to QT prolongation
• Has an active infection (e.g., pneumonia), congestive heart failure, bradyarrhythmia, or any uncontrolled disease (e.g., diabetic ketoacidosis, gastrointestinal obstruction) except for malignancy, which in the opinion of the investigator, might confound the results of the study or pose unwarranted risk in administering study drug to the participant
• Has had benzodiazepine or opioid therapy initiated within 48 hours of study drug administration, except for single daily doses of triazolam, temazepam, or midazolam
• Has been started on systemic corticosteroid therapy within 72 hours prior to study drug administration or is planned to receive a corticosteroid as part of the chemotherapy regimen
• Is currently taking warfarin