Aprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV)(0869-130)(COMPLETED)

• Status: Completed
• Trial end date: 2008-11-19
• Target enrollment: 0
• Participant gender: All

Summary

The study will test aprepitant for the prevention of CINV in patients receiving their initial cycle of Moderately Emetogenic Chemotherapy (MEC). Patients receiving more then one cycle of chemotherapy may opt to participate in an optional second cycle during which the patient will receive the same antiemetic regimen as cycle 1, except that an IV formulation of aprepitant will be given in place of the oral formulation on study day one. Study drug administration on subsequent days will be given orally as in cycle 1.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Aprepitant; BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Fosaprepitant; Ondansetron

Criteria

Inclusion Criteria:

• Patients will be naive to emetogenic chemotherapy with histologically or cytologically confirmed malignant disease scheduled to receive a single dose of moderately emetogenic chemotherapy on study day 1

• Karnofsky score of 60 or greater

Exclusion Criteria:

• Patient is scheduled to receive any dose of cisplatin

• Patient will receive abdominal or pelvic radiation a week prior and up to 6 days after initiation of chemotherapy

• Any allergies to study drug or antiemetics

• Taking CYP3A4 substrates/prohibited medication

• Significant medical or mental conditions

• Abnormal laboratory values (platelets, absolute neutrophils, AST, ALT, bilirubin or creatinine).