Aprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) Associated With Highly Emetogenic Chemotherapy (0869-801)(COMPLETED)
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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.
Condition or disease
Drug: MK0869, aprepitant / Duration of Treatment: 3 daysDrug: Comparator: ondansetron / Duration of Treatment: 4 days
A Randomized, Double-Blind, Parallel-Group Study Conducted Under In-House Blinding Conditions to Determine the Safety, Tolerability and Efficacy of Aprepitant Regimen Compared to Ondansetron Regimen for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) Associated With High Dose Cisplatin in Cycle 1
Actual Study Start Date :
January 13, 2004
Actual Primary Completion Date :
September 30, 2004
Actual Study Completion Date :
September 30, 2004
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.