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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 4

Conditions: Vomiting; Nausea; Breast Neoplasms

Treatments: Drug: Comparator: ondansetron / Duration of Treatment: 3 days; Drug: MK0869, aprepitant / Duration of Treatment: 3 days

Study type: Interventional

Funder types: Industry

Identifiers

NCT00092183

0869-071

2004_063

MK0869-071

Details and patient eligibility

About

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.

Enrollment: 866 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind