Clinical trial NCT01697579
Conditions: Chemotherapy-induced Nausea and Vomiting
Sponsor: Merck Sharp & Dohme LLC
Start date: 2012-12-13; Completion date: 2016-11-21
Enrollment: 240 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to determine the appropriate dosing regimen of fosaprepitant, when administered with ondansetron (with or without dexamethasone), for the prevention of CINV in children from birth to \<17 years of age. Fosaprepitant is a prodrug to aprepitant. All participants who completed the randomized Cycle 1 could elect to receive open-label fosaprepitant during optional Cycles 2-6.

Detailed description:
Under Amendment 01, 0517-029 enrolled participants in the following age cohorts: 2-\<6, 6-\<12 and 12-17 years old. The study was randomized, partially-blinded, with parallel group assignment. Participants were randomized to one of three fosaprepitant doses or the control group. (Amendment 02 and Amendment 03 were country-specific amendments in Brazil that were required as per local regulations with no change in study design.) Under Amendment 04, the 12-17 year-old cohort was closed since that cohort fully enrolled. An additional fosaprepitant dose was added and all participants were allocated to this one treatment group. Amendment 04 was open-label and enrolled participants in the following age cohorts: 0-\<2, 2-\<6 and 6-\<12 years old.

Arms: arm 1: Participants were administered intravenous (IV) fosaprepitant at the following weight-adjusted doses: participants 4 months to \<12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to \<4 months old were administered 2.5 mg/kg; participants 0 to \<1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone. arm 2: Participants 12 to 17 years old were administered 150 mg IV fosaprepitant. Participants 2 to \<12 years old were administered a weight-adjusted dose of 3 mg/kg (not to exceed 150 mg). Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone. arm 3: Participants 12 to 17 years old were administered 60 mg IV fosaprepitant. Participants 2 to \<12 years old were administered a weight-adjusted dose of 1.2 mg/kg (not to exceed 60 mg). Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone. arm 4: Participants 12 to 17 years old were administered 20 mg IV fosaprepitant. Participants 2 to \<12 years old were administered a weight-adjusted dose of 0.4 mg/kg (not to exceed 20 mg). Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone. arm 5: Participants were administered IV normal saline at volume to match age and weight specific doses of fosaprepitant. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone. arm 6: For optional Cycles 2-6, participants from the 5 mg/kg fosaprepitant arm in Cycle 1 were administered fosaprepitant 5 mg/kg IV (or age-adjusted equivalent). For Cycle 2, fosaprepitant was administered IV plus ondansetron with or without dexamethasone. For Cycles 3-6, fosaprepitant was administered IV plus a 5- hydroxytryptamine 3 (5-HT3) antagonist with or without dexamethasone. Participants 1 year or less were required to receive ondansetron in all cycles as the 5-HT3 antagonist. arm 7: For optional Cycles 2-6, participants from Cycle 1 fosaprepitant arms (3, 1.2, or 0.4 mg/kg) or Cycle 1 control arm were administered fosaprepitant 3 mg/kg IV (or age-adjusted equivalent). For Cycle 2, fosaprepitant was administered IV plus ondansetron with or without dexamethasone. For Cycles 3-6, fosaprepitant was administered IV plus a 5-HT3 antagonist with or without dexamethasone.
Interventions: intervention 1: Fosaprepitant intervention 2: Fosaprepitant Placebo intervention 3: Ondansetron intervention 4: 5-hydroxytryptamine 3 antagonist
Intervention descriptions: intervention 1: Administered intravenously (IV) as a single dose intervention 2: Administered IV as a single dose intervention 3: Administered IV according to local labeling and/or local standard of care intervention 4: Administered IV according to local labeling and/or local standard of care

Protocol documents: