Ovarian cancer in first relapse
Conditions
Interventions
Product Name: MORAb-003
Product Code: MORAb-003
Pharmaceutical Form: Intravenous infusion
Current Sponsor code: MORAb-003
Other descriptive name: humanized IgG monoclonal antibody
Concentration unit:
Sponsors
Morphotek
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the CA 125 response and the objective tumor response in subjects with either asymptomatic CA 125 elevation or measurable diesease;Secondary Objective: to obtain data regarding the safety and pharmacokinetics of the study drug;Primary end point(s): The number of patients showing a CA 125 response the duration of the CA 125 response objective tumor response | — |
Countries
Germany, Netherlands
Outcome results
None listed