NCT00092196CompletedPhase 3
Open-label Extension to: A Randomized, Double-Blind, Parallel-Group Study Conducted Under In-House Blinding Conditions to Determine the Efficacy and Tolerability of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting Associated With Moderately Emetogenic Chemotherapy
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 820
- Primary Endpoint
- Safety and tolerability
Study Overview
Brief Summary
The purpose of this study is to determine the efficacy and tolerability of an investigational drug for the prevention of chemotherapy-induced nausea and vomiting associated with moderately emetogenic chemotherapy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient with a diagnosis of breast cancer requiring treatment with non-cisplatin moderately emetogenic chemotherapy.
- •Patient must have completed participation in the main study for this protocol.
Exclusion Criteria
- •Patient has a central nervous system malignancy.
- •Patient will receive radiation to the abdomen or pelvis.
Outcomes
Primary Outcomes
Safety and tolerability
Secondary Outcomes
- Assessment of adverse experiences using the National Cancer Institute (NCI) criteria
Investigators
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