307
Participants
Start Date
September 13, 2011
Primary Completion Date
March 14, 2013
Study Completion Date
August 16, 2013
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
Aprepitant 80 mg
On the morning of Days 2 and 3: one 80 mg capsule PO for participants 12 to 17 years of age
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
Ondansetron
Day 1: Administered according to product label for pediatric usage or local standard of care
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
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
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
Emetogenic chemotherapy
"Any moderately or highly emetic chemotherapeutic agent such as cyclophosphamide, doxorubicin, methotrexate, carboplatin, cisplatin, irinotecan, carmustine, ifosfamide, and streptozocin, or chemotherapeutics of a lower emetogenicity that were not previously tolerated. No chemotherapeutic agents were specified by the protocol, and many could potentially have been used."
Merck Sharp & Dohme LLC
INDUSTRY