Trial Information
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
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
Safety and tolerability
Principal Investigator
Medical Monitor
Investigator Role:
Study Director
Investigator Affiliation:
Merck
Authority:
United States: Food and Drug Administration
Study ID:
2004_064
NCT ID:
NCT00092196
Start Date:
December 2002
Completion Date:
Related Keywords:
- Nausea
- Vomiting
- Breast Neoplasms
- Chemotherapy-Induced Nausea and Vomiting
- Breast Neoplasms
- Neoplasms
- Nausea
- Vomiting
