An Investigational Drug for the Prevention of Chemotherapy-Induced Nausea and Vomiting (MK-0869-071)

Phase 4

Completed

• Conditions: Nausea; Breast Neoplasms; Vomiting

• Registration Number: NCT00092183
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

This protocol will study an investigational drug treatment plan against standard therapy in the prevention of chemotherapy-induced nausea and vomiting in patients diagnosed with breast cancer who are to be treated with up to 4 cycles of non-cisplatin moderately emetogenic chemotherapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-10-10
• Primary Completion: 2003-12-01
• Study Completion: 2004-02-11
• Study First Submitted: 2004-09-21
• Study First Submitted QC: 2004-09-23
• Study First Posted: 2004-09-24
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-02
• Last Update Posted: 2017-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 866

Inclusion Criteria

• Patient with a diagnosis of breast cancer requiring treatment with non-cisplatin moderately emetogenic chemotherapy.

Exclusion Criteria

• Patient has a central nervous system malignancy.
• Patient will receive radiation to the abdomen or pelvis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Emesis and use of rescue medication
Safety and tolerability

Secondary Outcome Measures

Name	Time	Method
Quality of life