Conditions: Chemotherapy-Induced Nausea and Vomiting
Keywords: Prevention of Chemotherapy-Induced Nausea and Vomiting Palonosetron Ondansetron Pediatric
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 502
Healthy volunteers: no

Brief summary:
The primary objective is to evaluate the efficacy of two different doses of IV palonosetron in the prevention of chemotherapy induced nausea and vomiting in MEC and HEC patients through 120 hours after start of chemotherapy in single and repeated chemotherapy cycles. The secondary objectives are to evaluate the safety and tolerability of IV palonosetron in pediatric patients and evaluate the pharmacokinetics of IV palonosetron in a subset of pediatric CINV patients.

Detailed description:
For neonates (\<28 days, full term) an open-label sub-study will be conducted to assess exposure and tolerability in this age group with escalating doses of palonosetron, starting with 3 mcg/kg to the first three or more neonates included in the study. If this dose is shown to be safe and well tolerated then the following three neonates will be treated with a dose of 10 mcg/kg. If also this dose is safe and well tolerated, then the following three neonates will be treated with a dose of 20 mcg/kg. If this last dose is also shown to be safe and well tolerated, then all the following neonates will be randomized to the main study.

Arms:
arm 1: Palonosetron and placebo to Ondansetron

Intervention:

Drug: Palonosetron arm 2: Palonosetron and placebo to Ondansetron

Intervention:

Drug: Palonosetron arm 3: Ondansetron and placebo to Palonosetron

Drug:

Comparator: Ondansetron

Interventions: intervention 1: Palonosetron intervention 2: Palonosetron intervention 3: Ondansetron intervention 4: Placebo to Ondansetron intervention 5: Placebo to Ondansetron intervention 6: Placebo to Palonosetron
Intervention descriptions: intervention 1: Single dose Palonosetron IV 10 mcg/kg up to a maximum total dose of 0.75 mg intervention 2: Single dose Palonosetron IV 20 mcg/kg up to a maximum total dose of 1.5 mg intervention 3: Single three (every 4 hours) Ondansetron IV doses 0.15 mg/kg up to a maximum total dose of 32 mg intervention 4: None intervention 5: None intervention 6: None

Protocol document: