Clinical trial NCT01442376 (phase 3, status: completed)
Conditions: chemotherapy-induced nausea and vomiting
ICD codes: D61.810
Drugs: palonosetron, palonosetron, ondansetron, placebo to ondansetron, placebo to ondansetron, placebo to palonosetron
SMILES: [H][C@]12CCCC3=C1C(=CC=C3)C(=O)N(C2)[C@@H]1CN2CCC1CC2, [H][C@]12CCCC3=C1C(=CC=C3)C(=O)N(C2)[C@@H]1CN2CCC1CC2, CN1C2=C(C3=CC=CC=C13)C(=O)C(CN1C=CN=C1C)CC2, CN1C2=C(C3=CC=CC=C13)C(=O)C(CN1C=CN=C1C)CC2, CN1C2=C(C3=CC=CC=C13)C(=O)C(CN1C=CN=C1C)CC2, [H][C@]12CCCC3=C1C(=CC=C3)C(=O)N(C2)[C@@H]1CN2CCC1CC2
Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent signed by parent(s)/legal guardians of the pediatric patient
             in compliance with the local laws and regulations. In addition signed children's
             assent form according to local requirements

          -  Male or female in- or out-patients from neonates (full term) to <17 years at the time
             of randomization

          -  Patient weight at least 3.2 kg

          -  Histologically, and/or cytologically (or imaging in the case of brain tumors)
             confirmed malignant disease

          -  Naïve or non-naïve to chemotherapy

          -  Scheduled and eligible to receive at least one of the moderately or highly emetogenic
             chemotherapeutic agents on Study Day 1

          -  For patients aged ≥ 10 years to <17 years: ECOG PS ≤ 2

          -  For patients with known hepatic impairment: in the Investigator's opinion the
             impairment should not jeopardize patient's safety during the study

          -  For patients with known renal impairment: in the Investigator's opinion the impairment
             should not jeopardize patient's safety during the study

          -  For patients with known history or predisposition to cardiac abnormalities: in the
             Investigator's opinion the history/predisposition should not jeopardize patient's
             safety during the study

          -  For patients with known clinically relevant abnormal laboratory values: in the
             Investigator's opinion the abnormality should not jeopardize the patient's safety
             during the study

          -  Fertile patients (male or female) must use reliable contraceptive measures

          -  Female patients who have attained menarche must have a negative pregnancy test at the
             screening visit (Visit 1) and at study treatment visit (Visit 2)

        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