Ignite Creation Date:
2024-05-05 @ 10:14 PM
Last Modification Date:
2024-10-26 @ 10:16 AM
Study NCT ID:
NCT01065246
Status:
COMPLETED
Last Update Posted:
2012-10-03
First Post:
2010-01-13
Brief Title:
Safety Study of Second Intraperitoneal IP Infusion Cycle of Catumaxomab in Patients With Malignant Ascites
Sponsor:
Neovii Biotech
Organization:
Neovii Biotech
Study Overview
Official Title:
Phase II Open Label Study to Evaluate the Safety of a Second IP Infusion Cycle of Catumaxomab in Patients With Malignant Ascites Due to Carcinoma Requiring Their First Therapeutic Puncture After Treatment in the CASIMAS Study
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:
SECIMAS
Brief Summary:
This phase II single arm open-label study investigate the safety of a second cycle of catumaxomab in patients with malignant ascites due to carcinoma requiring their first therapeutic puncture after treatment in the CASIMAS study
Detailed Description:
Up to 30 evaluable patients from the CASIMAS study will be enrolled Catumaxomab will be infused intraperitoneally with 3hour constant-rate infusions 4 times within 11 days with ascending dosages 10 - 20 - 50 - 150 µg
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2009-014076-22 | EUDRACT_NUMBER | None | None |