A Randomized, Double-Blind, Parallel-Group Study Conducted Under In-House Blinding Conditions to Determine the Efficacy and Tolerability of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting Associated With Moderately Emetogenic Chemotherapy (Study #2)
- Conditions
- Chemotherapy-induced Nausea and Vomitting
- Registration Number
- EUCTR2006-003512-22-FR
- Lead Sponsor
- aboratoires Merck Sharp & Dohme-Chibret
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 700
Patient is at least 18 years of age
Patient has histologically or cytologically confirmed malignant disease
Patient is naïve to emetogenic cancer chemotherapy of moderate or high level per Hesketh.
Patient is scheduled to be treated with a single dose of one of the following moderately emetogenic chemotherapy agents (given intravenously) on treatment day 1:
-oxaliplatin, carboplatin, epirubicin, idarubicin, ifosfamide, irinotecan or mitoxantrone
-methotrexate (>250mg/m2)
-cyclophosphamide (<1500mg/m2)
-doxorubicin (>25mg/m2)
Patient has Karnofsky score >60.
See protocol for additional 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
Patient is scheduled to receive any dose of cisplatin.
Patient has or will receive radiation therapy to the abdomen or pelvis in the week prior to Day 1 through Day 6.
Patient has vomited in the 24 hours prior to Day 1.
See protocol for additional criteria.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method