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

Phase 4

Completed

• Conditions: Nausea; Vomiting

• Registration Number: NCT00090207
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01-13
• Study First Submitted: 2004-08-25
• Study First Submitted QC: 2004-08-26
• Study First Posted: 2004-08-27
• Primary Completion: 2004-09-30
• Study Completion: 2004-09-30
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-20
• Last Update Posted: 2017-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 477

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Patient vomiting

Secondary Outcome Measures

Name	Time	Method
Number of rescue therapies