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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Nausea, Vomiting, Breast Neoplasms

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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

Name

Location