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A Multicenter, Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Two Different Doses of Palonosetron Compared to Ondansetron in the Prevention of CINV in Pediatric Patients Undergoing Single and Repeated Cycles of MEC or HEC


Phase 3
N/A
16 Years
Not Enrolling
Both
Chemotherapy-Induced Nausea and Vomiting

Thank you

Trial Information

A Multicenter, Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Two Different Doses of Palonosetron Compared to Ondansetron in the Prevention of CINV in Pediatric Patients Undergoing Single and Repeated Cycles of MEC or HEC


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Change in proportion of patients with Complete Response (CR) defined as no vomiting, no retching, and no use of antiemetic rescue medication from 0 to 24 hours (acute phase) after T0 during first cycle

Outcome Description:

Time 0 (T0) is defined as the time when the patient starts the first cycle of chemotherapy

Outcome Time Frame:

0 to 24 hours after T0

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

PALO-10-20

NCT ID:

NCT01442376

Start Date:

September 2011

Completion Date:

November 2012

Related Keywords:

  • Chemotherapy-Induced Nausea and Vomiting
  • Prevention of Chemotherapy-Induced Nausea and Vomiting
  • Palonosetron
  • Ondansetron
  • Pediatric
  • Nausea
  • Vomiting

Name

Location

Medical University of South CarolinaCharleston, South Carolina  29425-0721
Nemours Children's ClinicJacksonville, Florida  32207
Nemours Children's Clinic-OrlandoOrlando, Florida  32806
Arkansas Children's HospitalLittle Rock, Arkansas  72202-3591
City of Hope National Medical CenterLos Angeles, California  91010
Nationwide Children's HospitalColumbus, Ohio  43205-2696
The Children'S HospitalDenver, Colorado  80218
Cook Children's Medical CenterFort Worth, Texas  76104
Upstate Medical UniversitySyracuse, New York  13210
A. I. duPont Hospital for ChildrenWilmington, Delaware  19803
Backus Children's Hospital at University PediatricsSavannah, Georgia  31404
University of Kentucky - Chandler Medical CenterLexington, Kentucky  40536
Department of PediatricsValhalla, New York  10595