A Study of the Efficacy of MORAb-003 in Subjects with Platinum-Sensitive Epithelial Ovarian Cancer in First Relapse
- Conditions
- Ovarian cancer in first relapse
- Registration Number
- EUCTR2006-003580-31-NL
- Lead Sponsor
- Morphotek
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 60
age over 18 years
diagnosis of epithelial platin-sensitive ovarian cancer in first relapse after a remission of 6 - 18 months
surgery to remove tumor before first remission
CA 125 elevation before first tratment
CA 125 elevation at the time of relapse
life expectancy over 6 months
ECOG performance status 0-2
eligible for retreatment with the same chemotherapy regimen that was used to induce remission
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
known central nervous system tumor involvement
evidence of other active malignancy requiring treatment
Clinically significant heart disease
ECG demonstrating clinically significant arrythmias
active serious systemic disease
active hepatitis or HIV infection
Treatment within three months with immunomodulatory therapy
breast-feeding, pregnancy or likely to become pregnant during study
participation in parallel studies
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