A MULTICENTER, OPEN-LABEL, 5-PART STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY, AND TOLERABILITY OF APREPITANT AND FOSAPREPITANT DIMEGLUMINE IN PEDIATRIC PATIENTS RECEIVING EMETOGENIC CHEMOTHERAPY.

MERCK SHARP & DOHME PERU S.R.L.,0 个研究点目标入组 10 人开始时间: 2012年5月14日最近更新: 2023年9月4日

试验速览

暂无简介。

•1. PATIENT IS O (AT LEAST 37 WEEKS GESTATION) TO 17 YEARS OF AGE ON THE DAY THEY ARE ALLOCATED INTO THE STUDY.
•2. PARENT/GUARDIAN (LEGALLY AUTHORIZED REPRESENTATIVE) AGREES TO THE PARIENT´S PARTICPATION AS INDICATED BY PARENTAL/LEGAL GUARDIAN SIGNATURE ON THE INFORMED CONSENT FORM AND PATIENT ASSENT DEPENDING ON THEIR AGE AND ABILITY TO UNDERSTAND THE NATURE AND INTENT OF THE STUDY INCLUIDING THE ABILITY TO COMPLY WITH STUDY PROCEDURES, COMPLETE STUDY QUESTIONNARIS, AND WILLING TO KEEP SCHEDULED STUDY VISITS.
•3. PATIENT IS SCHEDULED TO RECEIVE MODERATELY OR HIGHLY EMETOGENIC CHEMOTHERAPY FOR A DOCUMENTED MALIGNANCY AS DEFINED APPENDIX 6.1.
•PATIENT DID NOT TOLERATE A PREVIOUSLY ADMINISTERED CHEMOTHERAPY REGIMEN, FOR A DOCUMENTED MALIGNANCY, SECONDARY TO NAUSEA AND/OR VOMITING THAT IS PLANNED TO BE REPEATED.
•4. PATIENT IS EXPECTED TO RECEIVE ONDANSETRON AS PART OF THEIR ANTIEMETIC REGIMEN.
•5. FEMALE PATIENT WHO HAS BEGUN MENSES HAS A NEGATIVE URINE PREGNANCY TEST PRIOR TO RANDOMIZATION. FEMALES OF REPRODUCTIVS POTENTIAL WHO HAVE PREVIOUSLY BEEN SEXUALLY ACTIVE MUST AGREE TO USE A DOUBLE-BARRIER FORM OF CONTRACEPTION FOR AT LEAST 14 DAYS PRIOR TO, THROUGHOUT, AND FOR AT LEAST 1 MONTH FOLLOWING THE LAS DOSE OF STUDY MEDICATION.

•1. PATIENT IS CURRENTLY A USER OF ANY ILLICIT DRUGS, INCLUIDING MARIJUANA OR HAS CURRENT EVIDENCE OF ALCOHOL ABUSE (DEFINE USING DSM-IV CRITERIA) AS DETERMINED BY THE INVESTIGATOR.
•2. PATIENT IS SCHEDULED TO RECEIVE STEM CELL RESCUE THWRAPY IN CONJUNCTION WITH STUDY RELATED COURSE (S) OF EMETOGENIC CHEMOTHERAPY.
•3. PATIENT IS PREGNANT OR BREAST FEEDING OR SEXUALLY ACTIVE WITHOUT DOUBLE BARRIER CONTRACEPTION DURING STUDY ENROLLMENT. (FEMALES OF CHILD BEARING POTENTIAL ARE REQUIRED TO HAVE A NEGATIVE URINE PREGNANCY TEST PRIOR TO ENTERING THE STUDY).
•4. PATIENT HAS EVER PARTICIPATED IN A STUDY WITH APREPITANT OR FOSAPREPITANT, IS CURRENTLY PARTICIPATING IN A STUDY WITH CASOPITANT OR HAS TAKEN A NON-APPROVED (INVESTIGACIONAL) DRUG WITHIN THE LAST 4 WEEKS.
•NOTE: PATIENTS ON INVESTIGACIONAL STUDIES WITH MARKETED CHEMOTHERAPEUTIC AGENTS (WHETHER MARKETED EXPLICITY FOR CHILDREN OR ONLY MARKETED FOR ADULTS AND USUALLY APPLIED FOR CHILDREN AS WELL, WITH APPROPIATE DOSAGE ADJUSTMENTS) ARE ALLOWED TO ENROLL IF THEY FULFILL ALL OTHER ENTRY CRITERIA.
•5. PATIENT IS ALLERGIC TO APREPITANT, FOSAPREPITANT, ONDANSETRON OR ANY OTHER 5-HT3 ANTAGONIST.

发起方

MERCK SHARP & DOHME PERU S.R.L.,