A PHASE III, RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR-CONTROLLED CLINICAL TRIAL, CONDUCTED UNDER IN-HOUSE BLINDING CONDITIONS, TO EXAMINE THE EFFICACY AND SAFETY OF APREPITANT FOR THE PREVENTION OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING (CINV) IN PEDIATRIC PATIENTS

MERCK SHARP & DOHME PERU S.R.L.,0 个研究点目标入组 10 人开始时间: 2011年9月22日最近更新: 2023年9月4日

试验速览

暂无简介。

•2.2.1 CYCLE 1
•1. PATIENT IS 0 (AT LEAST 37 WEEKS GESTATION AND ≥ 3KG) TO 17 YEARS OF AGE AT THE TIME OF STUDY ENTRY.
•2. PARENT/GUARDIAN (LEGALLY AUTHORIZED REPRESENTATIVE) AGREES TO THE PATIENT´S PARTICIPATION AS INDICATED BY PARENT/LEGAL GUARDIAN SIGNATURE ON THE INFORMED CONSENT FORM. PATIENTS 12 TO 17 YEARS OF AGE, OR AS REQUIRED BY LOCAL REGULATION, ASSENTS AND HAS THE ABILITY TO UNDERSTAND THE NATURE AND INTENT OF THE STUDY INCLUDING THE ABILITY TO COMPLY WITH STUDY PROCEDURES, COMPLETE STUDY DIARY, AND IS WILLING TO KEEP SCHEDULED STUDY VISITS.
•3. PATIENT IS SCHEDULED TO RECEIVE CHEMOTHERAPEUTIC AGENT(S) ASSOCIATED WITH MODERATE, HIGH RISK OR VERY HIGH RISK OF EMETOGENICITY FOR A DOCUMENTED MALIGNANCY, OR A CHEMOTHERAPY REGIMEN NOT PREVIOUSLY TOLERATED DUE TO VOMITING.
•4. PATIENT IS EXPECTED TO RECEIVE ONDANSETRON AS PART OF THEIR ANTIEMETIC REGIMEN.
•FEMALE PATIENT WHO HAS BEGUN MENSES HAS A NEGATIVE URINE PREGNANCY TEST PRIOR TO RANDOMIZATION. A FEMALE PATIENT WHO IS OF REPRODUCTIVE POTENTIAL AGREES TO REMAIN ABSTINENT OR USE A BARRIER FORM OF CONTRACEPTION FOR AT LEST 14 DAYS PRIOR TO, THROUGHOUT, AND FOR AT LEAST ONE MONTH FOLLOWING THE LAST DOSE OF STUDY MEDICATION.

•2.3.1 CYCLE 1
•1. PATIENT HAS VOMITED IN THE 24 HOURS PRIOR TO TREATMENT DAY 1.
•2. PATIENT IS CURRENTLY A USER OF ANY ILLICIT DRUGS OR HAS CURRENT EVIDENCE OF ALCOHOL ABUSE (DEFINED USING DSM-IV CRITERIA) AS DETERMINED BY THE INVESTIGATOR.
•3. PATIENT IS SCHEDULED TO RECEIVE STEM CELL RESCUE THERAPY IN CONJUNCTION WITH STUDY RELATED COURSE(S) OF EMETOGENIC CHEMOTHERAPY.
•4. PATIENT IS PREGNANT OR BREAST FEEDING. (FEMALES OF CHILD BEARING POTENTIAL ARE REQUIRED TO HAVE A NEGATIVE URINE PREGNANCY TEST PRIOR TO ENTERING THE STUDY).
•5. PATIENTS ALLERGIC TO APREPITANT, ONDANSETRON, OR ANY OTHER 5-HT₃ ANTAGONIST.
•6. PATIENT HAS A SYMPTOMATIC PRIMARY OR METASTASIC CNS MALIGNANCY CAUSING NAUSEA AND/OR VOMITING. PATIENT WHO IS ASYMPTOMATIC IS ALLOWED TO PARTICIPATE.
•7. PATIENT HAS ABNORMAL LABORATORY VALUES AS FOLLOWS (DEVIATIONS FROM THESE GUIDELINES REQUIRE DISCUSSION WITH THE MERCK CLINICAL MONITOR):
•A. BASE MARROW FUNCTION
•i. PERIPERAL ABSOLUTE NEUTROPHIL COUNT (ANC) < 1000/mm³

发起方

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