<br>        Inclusion Criteria:<br><br>          -  Written informed consent signed by parent(s)/legal guardians of the pediatric patient<br>             in compliance with the local laws and regulations. In addition signed children's<br>             assent form according to local requirements<br><br>          -  Male or female in- or out-patients from neonates (full term) to <17 years at the time<br>             of randomization<br><br>          -  Patient weight at least 3.2 kg<br><br>          -  Histologically, and/or cytologically (or imaging in the case of brain tumors)<br>             confirmed malignant disease<br><br>          -  Naïve or non-naïve to chemotherapy<br><br>          -  Scheduled and eligible to receive at least one of the moderately or highly emetogenic<br>             chemotherapeutic agents on Study Day 1<br><br>          -  For patients aged = 10 years to <17 years: ECOG PS = 2<br><br>          -  For patients with known hepatic impairment: in the Investigator's opinion the<br>             impairment should not jeopardize patient's safety during the study<br><br>          -  For patients with known renal impairment: in the Investigator's opinion the impairment<br>             should not jeopardize patient's safety during the study<br><br>          -  For patients with known history or predisposition to cardiac abnormalities: in the<br>             Investigator's opinion the history/predisposition should not jeopardize patient's<br>             safety during the study<br><br>          -  For patients with known clinically relevant abnormal laboratory values: in the<br>             Investigator's opinion the abnormality should not jeopardize the patient's safety<br>             during the study<br><br>          -  Fertile patients (male or female) must use reliable contraceptive measures<br><br>          -  Female patients who have attained menarche must have a negative pregnancy test at the<br>             screening visit (Visit 1) and at study treatment visit (Visit 2)<br><br>        Exclusion Criteria:<br><br>          -  Lactating or pregnant female patient<br><br>          -  Patient has received total body irradiation, upper abdomen radiotherapy, radiotherapy<br>             of the cranium, craniospinal regions or the pelvis within 1 week prior to study entry<br>             (screening)<br><br>          -  Scheduled to receive concomitant total body irradiation, radiotherapy of the upper<br>             abdomen, lower thorax region, or cranium/craniospinal regions up to 24 hours after<br>             study drug administration<br><br>          -  Known history of allergy to any component or other contraindications to any 5-HT3<br>             receptor antagonists<br><br>          -  Active infection<br><br>          -  Uncontrolled medical condition<br><br>          -  Marked baseline prolongation of QTc interval [QTcB or QTcF > 460 msec] in any of the<br>             ECG assessments at screening. For this purpose, assessment will rely on the automatic<br>             interpretation by the ECG machine<br><br>          -  Patient suffering from ongoing vomiting from any organic etiology (including patients<br>             with history of gastric outlet obstruction or intestinal obstruction due to adhesions<br>             or volvulus) or patients with hydrocephalus<br><br>          -  Patient who experienced any vomiting, retching, or nausea within 24 hours prior to the<br>             administration of the study drug<br><br>          -  Patient who received any drug with potential anti-emetic effect within 24 hours prior<br>             to administration of study treatment, including but not limited to:<br><br>          -  NK1- receptor antagonists (e.g. aprepitant)<br><br>          -  5-HT3 antagonists (e.g., ondansetron, granisetron, dolasetron);<br><br>          -  Phenothiazines (e.g., perphenazine, prochlorperazine, promethazine, fluphenazine,<br>             chlorpromazine, thiethylperazine);<br><br>          -  Butyrophenones (e.g., droperidol, haloperidol);<br><br>          -  Benzamides (e.g., metoclopramide, alizapride);<br><br>          -  Corticosteroids (e.g., prednisone, methylprednisolone; except inhaled steroids for<br>             respiratory disorders and topical steroids for skin disease with doses of = 10 mg of<br>             prednisone daily or its equivalent); Corticosteroids foreseen in the chemotherapy<br>             regimen or to reduce intracranial pressure are allowed. According to the<br>             guidelines1,2, patients will receive also dexamethasone as a co-medication in<br>             accordance with standard clinical practice and if deemed appropriate by the<br>             Investigator.<br><br>          -  Dimenhydrinate; Hydroxyzine; Domperidone; Lorazepam; Cyclizine; Cannabinoids;<br>             Scopolamine; Trimethobenzamide HCl; Meclizine hydrochloride; Pseudoephedrine HCl;<br><br>          -  Over the Counter (OTC) antiemetics, OTC cold or OTC allergy medications;<br><br>          -  Herbal preparations containing ephedra or ginger.<br><br>          -  Patient aged = 6 years who received any investigational drug (defined as a medication<br>             with no marketing authorization granted for any age group and any indication) within<br>             90 days prior to Day 1, or patient aged > 6 years who received any investigational<br>             drug within 30 days prior to Day 1 or is expected to receive investigational drugs<br>             prior to study completion<br><br>          -  Patient who participated in any previous trial with palonosetron<br>      ;<br>        Inclusion Criteria:<br><br>          -  Written informed consent signed by parent(s)/legal guardians of the pediatric patient<br>             in compliance with the local laws and regulations. In addition signed children's<br>             assent form according to local requirements<br><br>          -  Male or female in- or out-patients from neonates (full term) to <17 years at the time<br>             of randomization<br><br>          -  Patient weight at least 3.2 kg<br><br>          -  Histologically, and/or cytologically (or imaging in the case of brain tumors)<br>             confirmed malignant disease<br><br>          -  Naïve or non-naïve to chemotherapy<br><br>          -  Scheduled and eligible to receive at least one of the moderately or highly emetogenic<br>             chemotherapeutic agents on Study Day 1<br><br>          -  For patients aged = 10 years to <17 years: ECOG PS = 2<br><br>          -  For patients with known hepatic impairment: in the Investigator's opinion the<br>             impairment should not jeopardize patient's safety during the study<br><br>          -  For patients with known renal impairment: in the Investigator's opinion the impairment<br>             should not jeopardize patient's safety during the study<br><br>          -  For patients with known history or predisposition to cardiac abnormalities: in the<br>             Investigator's opinion the history/predisposition should not jeopardize patient's<br>             safety during the study<br><br>          -  For patients with known clinically relevant abnormal laboratory values: in the<br>             Investigator's opinion the abnormality should not jeopardize the patient's safety<br>             during the study<br><br>          -  Fertile patients (male or female) must use reliable contraceptive measures<br><br>          -  Female patients who have attained menarche must have a negative pregnancy test at the<br>             screening visit (Visit 1) and at study treatment visit (Visit 2)<br><br>        Exclusion Criteria:<br><br>          -  Lactating or pregnant female patient<br><br>          -  Patient has received total body irradiation, upper abdomen radiotherapy, radiotherapy<br>             of the cranium, craniospinal regions or the pelvis within 1 week prior to study entry<br>             (screening)<br><br>          -  Scheduled to receive concomitant total body irradiation, radiotherapy of the upper<br>             abdomen, lower thorax region, or cranium/craniospinal regions up to 24 hours after<br>             study drug administration<br><br>          -  Known history of allergy to any component or other contraindications to any 5-HT3<br>             receptor antagonists<br><br>          -  Active infection<br><br>          -  Uncontrolled medical condition<br><br>          -  Marked baseline prolongation of QTc interval [QTcB or QTcF > 460 msec] in any of the<br>             ECG assessments at screening. For this purpose, assessment will rely on the automatic<br>             interpretation by the ECG machine<br><br>          -  Patient suffering from ongoing vomiting from any organic etiology (including patients<br>             with history of gastric outlet obstruction or intestinal obstruction due to adhesions<br>             or volvulus) or patients with hydrocephalus<br><br>          -  Patient who experienced any vomiting, retching, or nausea within 24 hours prior to the<br>             administration of the study drug<br><br>          -  Patient who received any drug with potential anti-emetic effect within 24 hours prior<br>             to administration of study treatment, including but not limited to:<br><br>          -  NK1- receptor antagonists (e.g. aprepitant)<br><br>          -  5-HT3 antagonists (e.g., ondansetron, granisetron, dolasetron);<br><br>          -  Phenothiazines (e.g., perphenazine, prochlorperazine, promethazine, fluphenazine,<br>             chlorpromazine, thiethylperazine);<br><br>          -  Butyrophenones (e.g., droperidol, haloperidol);<br><br>          -  Benzamides (e.g., metoclopramide, alizapride);<br><br>          -  Corticosteroids (e.g., prednisone, methylprednisolone; except inhaled steroids for<br>             respiratory disorders and topical steroids for skin disease with doses of = 10 mg of<br>             prednisone daily or its equivalent); Corticosteroids foreseen in the chemotherapy<br>             regimen or to reduce intracranial pressure are allowed. According to the<br>             guidelines1,2, patients will receive also dexamethasone as a co-medication in<br>             accordance with standard clinical practice and if deemed appropriate by the<br>             Investigator.<br><br>          -  Dimenhydrinate; Hydroxyzine; Domperidone; Lorazepam; Cyclizine; Cannabinoids;<br>             Scopolamine; Trimethobenzamide HCl; Meclizine hydrochloride; Pseudoephedrine HCl;<br><br>          -  Over the Counter (OTC) antiemetics, OTC cold or OTC allergy medications;<br><br>          -  Herbal preparations containing ephedra or ginger.<br><br>          -  Patient aged = 6 years who received any investigational drug (defined as a medication<br>             with no marketing authorization granted for any age group and any indication) within<br>             90 days prior to Day 1, or patient aged > 6 years who received any investigational<br>             drug within 30 days prior to Day 1 or is expected to receive investigational drugs<br>             prior to study completion<br><br>          -  Patient who participated in any previous trial with palonosetron<br>      ;<br>        Inclusion Criteria:<br><br>          -  Written informed consent signed by parent(s)/legal guardians of the pediatric patient<br>             in compliance with the local laws and regulations. In addition signed children's<br>             assent form according to local requirements<br><br>          -  Male or female in- or out-patients from neonates (full term) to <17 years at the time<br>             of randomization<br><br>          -  Patient weight at least 3.2 kg<br><br>          -  Histologically, and/or cytologically (or imaging in the case of brain tumors)<br>             confirmed malignant disease<br><br>          -  Naïve or non-naïve to chemotherapy<br><br>          -  Scheduled and eligible to receive at least one of the moderately or highly emetogenic<br>             chemotherapeutic agents on Study Day 1<br><br>          -  For patients aged = 10 years to <17 years: ECOG PS = 2<br><br>          -  For patients with known hepatic impairment: in the Investigator's opinion the<br>             impairment should not jeopardize patient's safety during the study<br><br>          -  For patients with known renal impairment: in the Investigator's opinion the impairment<br>             should not jeopardize patient's safety during the study<br><br>          -  For patients with known history or predisposition to cardiac abnormalities: in the<br>             Investigator's opinion the history/predisposition should not jeopardize patient's<br>             safety during the study<br><br>          -  For patients with known clinically relevant abnormal laboratory values: in the<br>             Investigator's opinion the abnormality should not jeopardize the patient's safety<br>             during the study<br><br>          -  Fertile patients (male or female) must use reliable contraceptive measures<br><br>          -  Female patients who have attained menarche must have a negative pregnancy test at the<br>             screening visit (Visit 1) and at study treatment visit (Visit 2)<br><br>        Exclusion Criteria:<br><br>          -  Lactating or pregnant female patient<br><br>          -  Patient has received total body irradiation, upper abdomen radiotherapy, radiotherapy<br>             of the cranium, craniospinal regions or the pelvis within 1 week prior to study entry<br>             (screening)<br><br>          -  Scheduled to receive concomitant total body irradiation, radiotherapy of the upper<br>             abdomen, lower thorax region, or cranium/craniospinal regions up to 24 hours after<br>             study drug administration<br><br>          -  Known history of allergy to any component or other contraindications to any 5-HT3<br>             receptor antagonists<br><br>          -  Active infection<br><br>          -  Uncontrolled medical condition<br><br>          -  Marked baseline prolongation of QTc interval [QTcB or QTcF > 460 msec] in any of the<br>             ECG assessments at screening. For this purpose, assessment will rely on the automatic<br>             interpretation by the ECG machine<br><br>          -  Patient suffering from ongoing vomiting from any organic etiology (including patients<br>             with history of gastric outlet obstruction or intestinal obstruction due to adhesions<br>             or volvulus) or patients with hydrocephalus<br><br>          -  Patient who experienced any vomiting, retching, or nausea within 24 hours prior to the<br>             administration of the study drug<br><br>          -  Patient who received any drug with potential anti-emetic effect within 24 hours prior<br>             to administration of study treatment, including but not limited to:<br><br>          -  NK1- receptor antagonists (e.g. aprepitant)<br><br>          -  5-HT3 antagonists (e.g., ondansetron, granisetron, dolasetron);<br><br>          -  Phenothiazines (e.g., perphenazine, prochlorperazine, promethazine, fluphenazine,<br>             chlorpromazine, thiethylperazine);<br><br>          -  Butyrophenones (e.g., droperidol, haloperidol);<br><br>          -  Benzamides (e.g., metoclopramide, alizapride);<br><br>          -  Corticosteroids (e.g., prednisone, methylprednisolone; except inhaled steroids for<br>             respiratory disorders and topical steroids for skin disease with doses of = 10 mg of<br>             prednisone daily or its equivalent); Corticosteroids foreseen in the chemotherapy<br>             regimen or to reduce intracranial pressure are allowed. According to the<br>             guidelines1,2, patients will receive also dexamethasone as a co-medication in<br>             accordance with standard clinical practice and if deemed appropriate by the<br>             Investigator.<br><br>          -  Dimenhydrinate; Hydroxyzine; Domperidone; Lorazepam; Cyclizine; Cannabinoids;<br>             Scopolamine; Trimethobenzamide HCl; Meclizine hydrochloride; Pseudoephedrine HCl;<br><br>          -  Over the Counter (OTC) antiemetics, OTC cold or OTC allergy medications;<br><br>          -  Herbal preparations containing ephedra or ginger.<br><br>          -  Patient aged = 6 years who received any investigational drug (defined as a medication<br>             with no marketing authorization granted for any age group and any indication) within<br>             90 days prior to Day 1, or patient aged > 6 years who received any investigational<br>             drug within 30 days prior to Day 1 or is expected to receive investigational drugs<br>             prior to study completion<br><br>          -  Patient who participated in any previous trial with palonosetron<br>      ;<br>        Inclusion Criteria:<br><br>          -  Written informed consent signed by parent(s)/legal guardians of the pediatric patient<br>             in compliance with the local laws and regulations. In addition signed children's<br>             assent form according to local requirements<br><br>          -  Male or female in- or out-patients from neonates (full term) to <17 years at the time<br>             of randomization<br><br>          -  Patient weight at least 3.2 kg<br><br>          -  Histologically, and/or cytologically (or imaging in the case of brain tumors)<br>             confirmed malignant disease<br><br>          -  Naïve or non-naïve to chemotherapy<br><br>          -  Scheduled and eligible to receive at least one of the moderately or highly emetogenic<br>             chemotherapeutic agents on Study Day 1<br><br>          -  For patients aged = 10 years to <17 years: ECOG PS = 2<br><br>          -  For patients with known hepatic impairment: in the Investigator's opinion the<br>             impairment should not jeopardize patient's safety during the study<br><br>          -  For patients with known renal impairment: in the Investigator's opinion the impairment<br>             should not jeopardize patient's safety during the study<br><br>          -  For patients with known history or predisposition to cardiac abnormalities: in the<br>             Investigator's opinion the history/predisposition should not jeopardize patient's<br>             safety during the study<br><br>          -  For patients with known clinically relevant abnormal laboratory values: in the<br>             Investigator's opinion the abnormality should not jeopardize the patient's safety<br>             during the study<br><br>          -  Fertile patients (male or female) must use reliable contraceptive measures<br><br>          -  Female patients who have attained menarche must have a negative pregnancy test at the<br>             screening visit (Visit 1) and at study treatment visit (Visit 2)<br><br>        Exclusion Criteria:<br><br>          -  Lactating or pregnant female patient<br><br>          -  Patient has received total body irradiation, upper abdomen radiotherapy, radiotherapy<br>             of the cranium, craniospinal regions or the pelvis within 1 week prior to study entry<br>             (screening)<br><br>          -  Scheduled to receive concomitant total body irradiation, radiotherapy of the upper<br>             abdomen, lower thorax region, or cranium/craniospinal regions up to 24 hours after<br>             study drug administration<br><br>          -  Known history of allergy to any component or other contraindications to any 5-HT3<br>             receptor antagonists<br><br>          -  Active infection<br><br>          -  Uncontrolled medical condition<br><br>          -  Marked baseline prolongation of QTc interval [QTcB or QTcF > 460 msec] in any of the<br>             ECG assessments at screening. For this purpose, assessment will rely on the automatic<br>             interpretation by the ECG machine<br><br>          -  Patient suffering from ongoing vomiting from any organic etiology (including patients<br>             with history of gastric outlet obstruction or intestinal obstruction due to adhesions<br>             or volvulus) or patients with hydrocephalus<br><br>          -  Patient who experienced any vomiting, retching, or nausea within 24 hours prior to the<br>             administration of the study drug<br><br>          -  Patient who received any drug with potential anti-emetic effect within 24 hours prior<br>             to administration of study treatment, including but not limited to:<br><br>          -  NK1- receptor antagonists (e.g. aprepitant)<br><br>          -  5-HT3 antagonists (e.g., ondansetron, granisetron, dolasetron);<br><br>          -  Phenothiazines (e.g., perphenazine, prochlorperazine, promethazine, fluphenazine,<br>             chlorpromazine, thiethylperazine);<br><br>          -  Butyrophenones (e.g., droperidol, haloperidol);<br><br>          -  Benzamides (e.g., metoclopramide, alizapride);<br><br>          -  Corticosteroids (e.g., prednisone, methylprednisolone; except inhaled steroids for<br>             respiratory disorders and topical steroids for skin disease with doses of = 10 mg of<br>             prednisone daily or its equivalent); Corticosteroids foreseen in the chemotherapy<br>             regimen or to reduce intracranial pressure are allowed. According to the<br>             guidelines1,2, patients will receive also dexamethasone as a co-medication in<br>             accordance with standard clinical practice and if deemed appropriate by the<br>             Investigator.<br><br>          -  Dimenhydrinate; Hydroxyzine; Domperidone; Lorazepam; Cyclizine; Cannabinoids;<br>             Scopolamine; Trimethobenzamide HCl; Meclizine hydrochloride; Pseudoephedrine HCl;<br><br>          -  Over the Counter (OTC) antiemetics, OTC cold or OTC allergy medications;<br><br>          -  Herbal preparations containing ephedra or ginger.<br><br>          -  Patient aged = 6 years who received any investigational drug (defined as a medication<br>             with no marketing authorization granted for any age group and any indication) within<br>             90 days prior to Day 1, or patient aged > 6 years who received any investigational<br>             drug within 30 days prior to Day 1 or is expected to receive investigational drugs<br>             prior to study completion<br><br>          -  Patient who participated in any previous trial with palonosetron<br>