Ignite Creation Date:
2024-05-05 @ 9:10 PM
Last Modification Date:
2024-10-26 @ 10:00 AM
Study NCT ID:
NCT00822809
Status:
COMPLETED
Last Update Posted:
2012-10-03
First Post:
2008-12-23
Brief Title:
CASIMAS Catumaxomab Safety Phase IIIb Study With Intraperitoneal Infusion in Patients With Malignant Ascites Due to Epithelial Cancers
Sponsor:
Neovii Biotech
Organization:
Neovii Biotech
Study Overview
Official Title:
Two-arm Randomized Open-label Phase IIIb Study Investigating the Safety of a 3 Hour ip Infusion of Catumaxomab With and Without Prednisolone Premedication in Patients With Malignant Ascites Due to Epithelial Cancer
Status:
COMPLETED
Status Verified Date:
2012-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CASIMAS
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 catumaxomab treatment more convenient for the patient and the hospital praxis the tolerability of 3 hour infusions of catumaxomab with and without premedication of prednisolone is evaluated
A total of 208 patients with malignant ascites due to epithelial cancer will be allocated to two treatment groups in a 11 ratio
A total of 208 patients with malignant ascites due to epithelial cancer will be allocated to two treatment groups in a 11 ratio
Detailed Description:
Safety data of the completed pivotal phase IIIII trial IP-REM-AC-01 in which catumaxomab was administered as 6 hour ip infusion showed that most reported AEs were cytokine release-related symptoms such as fever nausea and vomiting based on the pharmacodynamic mode of action of catumaxomab and abdominal pain In order to make the catumaxomab treatment more convenient for the patient and the hospital praxis the current trial was designed to determine whether tolerability of the 3 hour infusion of catumaxomab with and without premedication of prednisolone Prednisolone was chosen as additional premedication with the objective to reduce cytokine release related symptoms which might change with the switch from 6 to 3 h infusion time
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None