Efficacy and Safety of Palonosetron Intravenous in Prevention of Chemotherapy Induced Nausea and Vomiting in Pediatric Patients

Exclusion Criteria

• •Lactating or pregnant female patient
• •Patient has received total body irradiation, upper abdomen radiotherapy, radiotherapy of the cranium, craniospinal regions or the pelvis within 1 week prior to study entry (screening)
• •Scheduled to receive concomitant total body irradiation, radiotherapy of the upper abdomen, lower thorax region, or cranium/craniospinal regions up to 24 hours after study drug administration
• •Known history of allergy to any component or other contraindications to any 5-HT3 receptor antagonists
• •Active infection
• •Uncontrolled medical condition
• •Marked baseline prolongation of QTc interval \[QTcB or QTcF \> 460 msec\] in any of the ECG assessments at screening. For this purpose, assessment will rely on the automatic interpretation by the ECG machine
• •Patient suffering from ongoing vomiting from any organic etiology (including patients with history of gastric outlet obstruction or intestinal obstruction due to adhesions or volvulus) or patients with hydrocephalus
• •Patient who experienced any vomiting, retching, or nausea within 24 hours prior to the administration of the study drug
• •Patient who received any drug with potential anti-emetic effect within 24 hours prior to administration of study treatment, including but not limited to:
• •NK1- receptor antagonists (e.g. aprepitant)
• •5-HT3 antagonists (e.g., ondansetron, granisetron, dolasetron);
• •Phenothiazines (e.g., perphenazine, prochlorperazine, promethazine, fluphenazine, chlorpromazine, thiethylperazine);
• •Butyrophenones (e.g., droperidol, haloperidol);
• •Benzamides (e.g., metoclopramide, alizapride);
• •Corticosteroids (e.g., prednisone, methylprednisolone; except inhaled steroids for respiratory disorders and topical steroids for skin disease with doses of ≤ 10 mg of prednisone daily or its equivalent); Corticosteroids foreseen in the chemotherapy regimen or to reduce intracranial pressure are allowed. According to the guidelines1,2, patients will receive also dexamethasone as a co-medication in accordance with standard clinical practice and if deemed appropriate by the Investigator.
• •Dimenhydrinate; Hydroxyzine; Domperidone; Lorazepam; Cyclizine; Cannabinoids; Scopolamine; Trimethobenzamide HCl; Meclizine hydrochloride; Pseudoephedrine HCl;
• •Over the Counter (OTC) antiemetics, OTC cold or OTC allergy medications;
• •Herbal preparations containing ephedra or ginger.
• •Patient aged ≤ 6 years who received any investigational drug (defined as a medication with no marketing authorization granted for any age group and any indication) within 90 days prior to Day 1, or patient aged \> 6 years who received any investigational drug within 30 days prior to Day 1 or is expected to receive investigational drugs prior to study completion
• •Patient who participated in any previous trial with palonosetron