A PHASE IIB, PARTIALLY-BLINDED, RANDOMIZED, ACTIVE COMPARATOR-CONTROLLED STUDY TO EVALUATE THE PHARMACOKINETICS/PHARMACODYNAMICS, SAFETY, AND TOLERABILITY OF FOSAPREPITANT IN PEDIATRIC PATIENTS FOR THE PREVENTION OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING (CINV) ASSOCIATED WITH EMETOGENIC CHEMOTHERAPY.

Not Applicable

• Registration Number: PER-109-12
• Lead Sponsor: MERCK SHARP & DOHME PERU S.R.L.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-09-19
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

1. PATIENT IS 0 (AT LEAST 37 WEEKS GESTATION) TO 17 YEARS OF AGE AT TIME OF STUDY ENTRY (RANDOMIZATION).
2. PARENT/GUARDIAN (LEGALLY AUTHORIZED REPRESENTATIVE) AGREES TO THE PATIENT´S PARTICIPATION AS INDICATED BY PARENT/LEGAL GUARDIAN SIGNATURE ON THE INFORMED CONSENT FORM. PATIENT 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. THE PARENT/GUARDIAN OR PATIENT MAY ALSO PROVIDE CONSENT/ASSENT FOR FUTURE BIOMEDICAL RESEARCH. HOWEVER, THE PATIENT MAY PARTICIPATE IN THE MAIN TRIAL WITHOUT PARTICIPATING IN THE FUTURE BIOMEDICAL RESEARCH.
3. PATIENT IS SCHEDULED TO RECEIVE CHEMOTHERAPEUTIC AGENT(S) ASSOCIATED WITH MODERATE, HIGH, OR VERY HIGH RISK OF EMETOGENICITY FOR NO MORE THAN 5 CONSECUTIVE DAYS 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.
5. FEMALE PATIENT WHO HAS BEGUN MENSES HAS A NEGATIVE URINE PREGNANCY TEST PRIOR TO RANDOMIZATION.

Exclusion Criteria

EXCLUSION CRITERIA IN CYCLE 1
1. PATIENT HAS VOMITED IN THE 24 HOURS PRIOR TO CHEMOTHERAPY INITIATION ON TREATMENT DAY 1.
2. PATIENT IS CURRENTLY A USER OF ANY ILLICIT DRUGS (INCLUDING MARIJUANA) OR HAS CURRENT EVIDENCE OF ALCOHOL ABUSE (DEFINED USING THE DIAGNOSTIC AND STATISTICAL MANUAL-IV [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 HAS RECEIVED OR WILL RECEIVE RADIATION THERAPY TO THE ABDOMEN OR PELVIS IN THE WEEK PRIOR TO TREATMENT DAY 1 AND/OR DURING THE COURSE OF THE STUDY.
5. 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.)
6. PATIENT IS ALLERGIC TO FOSAPREPITANT, APREPITANT, ONDANSETRON, OR ANY OTHER 5-HT³ ANTAGONIST.
7. PATIENT HAS A SYMPTOMATIC PRIMARY OR METASTATIC CENTRAL NERVOUS SYSTEM (CNS) MALIGNANCY CAUSING NAUSEA AND/OR VOMITING. PATIENT WHO IS ASYMPTOMATIC IS ALLOWED TO PARTICIPATE.
8. PATIENT HAS ABNORMAL LABORATORY VALUES AS FOLLOWS (DEVIATIONS FROM THESE GUIDELINES REQUIRE DISCUSSION WITH THE MERCK CLINICAL MONITOR):

Study & Design

• Study Type: Interventional
• Study Design: Not specified