Status:
COMPLETED
Evaluation of Fosaprepitant (MK0517) in Single Dose Schedule (0517-017)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Chemotherapy-Induced Nausea and Vomiting (CINV)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to examine the safety, tolerability, and efficacy of MK0517 to prevent Chemotherapy-Induced Nausea and Vomiting (CINV) associated with Cisplatin chemotherapy.
Eligibility Criteria
Inclusion
- Patient is male or female and is at least 18 years of age; scheduled to receive his or her first course of cisplatin chemotherapy at a dose of 70 mg/m2 or higher; predicted life expectancy of 3 months or greater
- Patient is post menopausal or, if premenopausal, must use double-barrier contraception
Exclusion
- Patient has symptomatic primary or metastatic CNS malignancy
- Patient has received or will receive Radiation therapy to the abdomen or pelvis in the week prior to Treatment Day 1 though Day 6
- Patient has vomited in the 24 hours prior to treatment Day 1
- Patient has an active infection; Patient uses illicit drugs or has current evidence of alcohol abuse
- Patient is pregnant or breast feeding
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
2322 Patients enrolled
Trial Details
Trial ID
NCT00619359
Start Date
February 1 2008
End Date
June 1 2009
Last Update
March 21 2017
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