Aprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) Associated With Highly Emetogenic Chemotherapy (0869-801)(COMPLETED)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 4

Conditions: Vomiting; Nausea

Treatments: Drug: MK0869, aprepitant / Duration of Treatment: 3 days; Drug: Comparator: ondansetron / Duration of Treatment: 4 days

Study type: Interventional

Funder types: Industry

Identifiers

NCT00090207

2004_005

0869-801

Details and patient eligibility

About

A multicenter trial to assess the safety and efficacy of an investigational drug in the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with confirmed solid tumors who will be treated with a chemotherapy regimen that includes cisplatin. The study will evaluate the investigational drug for the treatment of CINV during the first cycle of treatment with cisplatin.

Enrollment: 477 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Patient is greater than 18 years of age.
• Patient is scheduled to receive his/her first

course of cisplatin chemotherapy for a solid tumor.

• Patient has a prognosis (life expectancy) greater than or equal to 3 months.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind