Phase II Study of the Trifunctional Antibody Catumaxomab Administered Intra- and Postoperatively in Patients With Ovarian Cancer
NCT00563836 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41
Last updated 2012-10-03
Summary
Primary evaluation of the safety, tolerability and feasibility regarding specific postoperative complications of an adjuvant treatment with catumaxomab administered after tumor resection.
Conditions
- Ovarian Cancer
- Epithelial Ovarian Cancer
Interventions
- DRUG
-
Catumaxomab
10 µg Catumaxomab intraoperatively and 4 ascending doses (10, 20, 50 and 150 µg) on day 7, 10, 13 and 16
Sponsors & Collaborators
-
Neovii Biotech
lead INDUSTRY
Principal Investigators
-
Jahlid Sehouli, MD · Klinikum Charité, 13355 Berlin
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-11-30
- Primary Completion
- 2008-09-30
- Completion
- 2010-08-31
Countries
- Austria
- Germany
Study Locations
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