A Phase II Multicenter, Randomized, Double-Blind, Placebo and Active-Controlled, Dose-Ranging, Parallel Group Study of the Safety and Efficacy of The Oral Neurokinin-1 Receptor Antagonist, GW679769 When Administered at Daily doses of 50 mg, 100 mg, and 150 mg Oral Tablets in Combination with Ondansetron Hydrochloride and Dexamethasone for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Cancer Subjects Receiving Highly Emetogenic Cisplatin-based Chemotherapy
- Conditions
- Prevention of CINV in patients who have been diagnosed with a malignant solid tumor where treatment with a single day of HEC (>70mg/m2) as platin based regimen for one or more cycle is appropriate
- Registration Number
- EUCTR2004-000371-34-IT
- Lead Sponsor
- GLAXO SMITHKLINE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 492
Inclusion Criteria
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: ;Secondary Objective: ;Primary end point(s):
- Secondary Outcome Measures
Name Time Method