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)
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)
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. Those who complete this first cycle of treatment and meet certain
 eligibility criteria will have the option of continuing for 5 additional cycles of open-label
 aprepitant.
Inclusion Criteria:

 Cycle 1:

 -  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

 Optional Cycles 2-6:

 -  Participant has, in the opinion of the investigator, completed the preceding cycle of
 chemotherapy and related study procedures satisfactorily

 Exclusion Criteria:

 Cycle 1:

 -  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

 Optional Cycles 2-6:

 -  All exclusion criteria from Cycle 1 apply except for vomiting in the 24 hours prior to
 Treatment Day 1