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

Helsinn HealthCare S.A,0 个研究点目标入组 19 人开始时间: 2011年9月26日最近更新: 2023年9月4日

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•1. WRITTEN INFORMED CONSENT SIGNED BY PARENT(S)/LEGAL GUARDIANS OF THE TO PEDIATRIC PATIENT IN COMPLIANCE WITH THE LOCAL LAWS AND REGULATIONS. IN ADDITION SIGNED CHILDREN´S ASSENT FORM ACCORDING TO LOCAL REQUIREMENTS.
•2. MALE OR FEMALE IN- OR OUT-PATIENTS FROM NEONATES (FULL TERM) TO < 17 YEARS AT THE TIME OF RANDOMIZATION.
•3. PATIENT WEIGHT AT LEAST 3.2 kg.
•4. HISTOLOGICALLY, AND/OR CYTOLOGICALLY (OR IMAGING IN THE CASE OF BRAIN TUMORS) CONFIRMED MALIGNANT DISEASE.
•5. NAIVE OR NON-NAIVE TO CHEMOTHERAPY.
•6. SCHEDULED AND ELIGIBLE TO RECEIVE AT LEAST ONE OF THE MODERATELY OR HIGHLY EMEOGENIC CHEMOTHERAPEUTIC AGENTS (THE MOST EMETOGENIC AGENT - APPENDIX E) ON STUDY DAY 1.
•7. FOR PATIENTS AGED ≥ 10 YEARS TO < 17 YEARS: EASTERN COOPERATIVE ONCOLOGY GROUP PERFORMANCE STATUS (ECOG PS) ≤ 2 (APPENDIX D).
•8. FOR PATIENTS WITH KNOWN HEPATIC IMPAIRMENT (DEFINED AS AST > 2.5 ULN OR ALT > 2.5 ULN OR TOTAL BILIRUBIN > 1.5 ULN): IN THE INVESTIGATOR´S OPINION THE IMPARMENT SHOULD NOT JEOPARDIZE PATIENT´S SAFETY DURING THE STUDY.

•1. THE PATIENT AND/OR PARENTS/CAREGIVERS ARE EXPECTED BY THE INVESTIGATOR TO BE NON-COMPLIANT WITH THE STUDY PROCEDURES.
•2. LACTATING OR PREGNANT FEMALE PATIENT.
•3. PATIENT HAS RECEIVED TOTAL BODY IRRADIATION, RADIOTHERAPY OF THE UPPER ABDOMEN, LOWER THORAX REGION, OR CRANIUM/CRANIOSPINAL REGIONS OR THE PELVIS WITHIN 1 WEEK PRIOR TO STUDY ENTRY (SCREENING).
•4. SCHEDULED TO RECEIVE COCOMITANT TOTAL BODY IRRADIATION, RADIOTHERAPY OF THE UPPER ABDOMEN, LOWER THORAX REGION, OR CRANIUM/CRANIOSPINAL REGIONS UP TO 24 HOURS AFTER STUDY DRUG ADMINISTRATION.
•5. KNOWN HISTORY OF ALLERGY TO ANY COMPONENT OR OTHER CONTRAINDICATIONS TO ANY 5-HT3 RECEPTOR ANTAGONIST.
•6. ACTIVE INFECTION.
•7. UNCONTROLLED MEDICAL CONDITION (eg, UNCONTROLLED INSULIN-DEPENDENT DIABETES MELLITUS).
•8. 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.

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