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Clinical Trials/NL-OMON48224
NL-OMON48224
Completed
Phase 4

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 - MK0517-045

Merck Sharp & Dohme (MSD)0 sites6 target enrollmentTBD
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ConditionsSymptomen en algemene pathologieChemotherapy-Induced Nausea and Vomiting

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Symptomen en algemene pathologie
Sponsor
Merck Sharp & Dohme (MSD)
Enrollment
6
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
Merck Sharp & Dohme (MSD)

Eligibility Criteria

Inclusion Criteria

  • •Inclusion Criteria for Cycle 1
  • •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) as defined in Appendix 9
  • •of the protocol.
  • •3\. Have a preexisting functional central venous catheter available for study
  • •intervention administration.
  • •4\. Be fosaprepitant naïve.
  • •Demographics

Exclusion Criteria

  • •Exclusion Criteria for Cycle 1 Only
  • •Medical Conditions
  • •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
  • •Exclusion Criteria for Cycle 1 and Optional Cycles 2 and 3

Outcomes

Primary Outcomes

Not specified

Similar Trials

Active, not recruiting
Phase 1
Three-day Fosaprepitant Regimen CINV Safety Study in Pediatric ParticipantsPrevention 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]
EUCTR2018-004844-43-GRMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.100
Active, not recruiting
Phase 1
Three-day Fosaprepitant Regimen CINV Safety Study in Pediatric ParticipantsPrevention of Chemotherapy-Induced Nausea and Vomiting (CINV)MedDRA version: 20.1Level: PTClassification code 10054133Term: Prophylaxis of nausea and vomitingSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Diseases [C] - Symptoms and general pathology [C23]
EUCTR2018-004844-43-NLMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.100
Active, not recruiting
Phase 1
Three-day Fosaprepitant Regimen CINV Safety Study in Pediatric Participants
EUCTR2018-004844-43-PLMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.100
Active, not recruiting
Phase 1
Three-day Fosaprepitant Regimen CINV Safety Study in Pediatric ParticipantsPrevention of Chemotherapy-Induced Nausea and Vomiting (CINV)MedDRA version: 20.1Level: PTClassification code 10054133Term: Prophylaxis of nausea and vomitingSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Diseases [C] - Symptoms and general pathology [C23]
EUCTR2018-004844-43-LTMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.100
Active, not recruiting
Phase 1
Three-day Fosaprepitant Regimen CINV Safety Study in Pediatric Participants
EUCTR2018-004844-43-HUMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.100