Trials / Completed
CompletedNCT00836654
Study in EpCAM Positive Patients With Symptomatic Malignant Ascites Using Removab Versus an Untreated Control Group
Two-Arm, Randomized (2:1), Open-Label Phase II/III Study in EpCAM Positive Cancer Patients With Symptomatic Malignant Ascites Using the Trifuncitonal Bispecific Antibody Removab (Anti-EpCAM x Anti-CD3) Versus an Untreated Control Group
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 258 (actual)
- Sponsor
- Neovii Biotech · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The study will be performed to obtain further efficacy and safety data in order to obtain a marketing authorization (pivotal study). In addition, health economic data are to be collected.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Catumaxomab (Removab) | Puncture free survival |
| PROCEDURE | paracentesis |
Timeline
- Start date
- 2004-09-01
- Primary completion
- 2006-11-01
- Completion
- 2006-11-01
- First posted
- 2009-02-04
- Last updated
- 2009-02-05
Source: ClinicalTrials.gov record NCT00836654. Inclusion in this directory is not an endorsement.