EUCTR2018-004844-43-GR
Active, not recruiting
Phase 1
A Phase 4, Open-label, Single Arm Study to Evaluate the Safety and Tolerability of a Three-day Fosaprepitant Regimen Administered for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Pediatric Participants Receiving Emetogenic Chemotherapy
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.0 sites100 target enrollmentAugust 7, 2019
ConditionsPrevention of Chemotherapy-Induced Nausea and Vomiting (CINV)MedDRA version: 21.1Level: PTClassification code 10054133Term: Prophylaxis of nausea and vomitingSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Diseases [C] - Symptoms and general pathology [C23]
DrugsIVEMEND®
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV)
- Sponsor
- Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
- Enrollment
- 100
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •To be eligible for inclusion in this study, the participant must:
- •1\. Be receiving a moderately or highly emetogenic chemotherapy agent/regimen or a chemotherapy agent/regimen not previously tolerated due to vomiting.
- •2\. Have a Lansky Play Performance score \=60 (participants \=16 years of age) or a Karnofsky score \=60 (participants \>16 years of age).
- •3\. Have a preexisting functional central venous catheter available for study intervention administration.
- •4\. Be fosaprepitant naïve.
- •5\. Have a predicted life expectancy \=3 months.
- •6\. Be male or female.
- •A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
- •\- Is not a woman of childbearing potential (WOCBP) OR
- •\- Is a WOCBP and agrees to the following for at least 28 days prior to receiving study intervention, during the intervention period, and for at least 30 days (or local standard of care if longer) after the last dose of study intervention (including the optional cycles):
Exclusion Criteria
- •The participant must be excluded from the study if the participant:
- •1\. Has abnormal laboratory values as follows:
- •\- peripheral absolute neutrophil count (ANC) \<1000/mm3
- •\- platelet count \<75,000/mm3
- •\- aspartate aminotransferase (AST) \>5\.0 × upper limit of normal (ULN) for age
- •\- alanine aminotransferase (ALT) \>5\.0 × ULN for age
- •\- bilirubin \>1\.5 × ULN for age
- •\- creatinine \>1\.5 × ULN for age
- •2\. Will receive stem cell rescue therapy in conjunction with a study\-related course of emetogenic chemotherapy or during the 14 days following administration of fosaprepitant.
- •3\. Is currently a user of any recreational or illicit drugs or has current evidence of drug or alcohol abuse or dependence as determined by the investigator.
Outcomes
Primary Outcomes
Not specified
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