Status:
COMPLETED
CASIMAS: Catumaxomab Safety Phase IIIb Study With Intraperitoneal Infusion in Patients With Malignant Ascites Due to Epithelial Cancers
Lead Sponsor:
Neovii Biotech
Conditions:
Cancer
Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a randomized phase IIIb study investigating the treatment of malignant ascites due to epithelial cancer (carcinomas) with the trifunctional antibody catumaxomab. In order to make the catumaxom...
Detailed Description
Safety data of the completed pivotal phase II/III trial, IP-REM-AC-01, in which catumaxomab was administered as 6 hour i.p. infusion showed that most reported AEs were cytokine release-related symptom...
Eligibility Criteria
Inclusion
- Key
- Patients with malignant ascites requiring therapeutic ascites puncture
- Histological confirmed diagnosis of epithelial cancer
- Patients where standard therapy is not available or no longer feasible
- Karnofsky index ≥60 %
- Life expectancy \>12 weeks
- Key
Exclusion
- Concomitant treatment with other investigational product, chemo-, or radiotherapy
- Recent exposure to an investigational product
- Known or suspected hypersensitivity to catumaxomab or similar antibodies
- Inadequate respiratory, renal or hepatic function
- Inadequate blood count (platelets, neutrophils)
- Required entirely parenteral nutrition
- Patients with ileus or subileus within the last 30 days
- Liver metastases with volume \>70 % of liver tissue
- Known portal vein obstruction
- Known Brain metastases
- Acute or chronic infection
- Not sufficiently recovered from previous treatment (toxicity present) based on laboratory values and general status
- Albumin lower than 3 g/dL or total protein \< 6g/dL
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT00822809
Start Date
December 1 2008
End Date
April 1 2011
Last Update
October 3 2012
Active Locations (4)
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1
Study Site
Several, France
2
Study site
Several, Germany
3
Study Site
Several, Italy
4
Study Site
Several, Spain