Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00377429
Status:
COMPLETED
Last Update Posted:
2012-07-19
First Post:
2006-09-15
Brief Title:
Safety and Efficacy Study of Catumaxomab to Treat Ovarian Cancer After a Complete Response to Chemotherapy
Sponsor:
Neovii Biotech
Organization:
Neovii Biotech
Study Overview
Official Title:
An Open-Label Single-Arm Phase II Safety and Tolerability Study of Catumaxomab Anti-EpCAM x Anti-CD3 in Women With Advanced Epithelial Ovarian Cancer After a Complete Response to Chemotherapy
Status:
COMPLETED
Status Verified Date:
2012-07
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:
None
Brief Summary:
The purpose of this study is to determine whether the investigational drug catumaxomab delivered in the planned treatment schedule is a safe and effective treatment for women with advanced ovarian cancer who experience a complete response to chemotherapy
Detailed Description:
A multi-center phase II study of catumaxomab in ovarian cancer patients who experience a complete response to chemotherapy Each eligible patient will receive four ascending doses of catumaxomab administered intraperitoneally via an indwelling catheter or port Catumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval of 3-4 days Each patient will participate in this study for up to 4 months includes the baseline screening period 11 to 21 days treatment period and up to 90 days3 months follow-up with post-study follow-up every 3 months for 2 years
Catumaxomab is a trifunctional antibody targeting epithelial cell adhesion molecule EpCAM on tumor cells and CD3 cluster of differentiation 3 on T cells Trifunctional antibodies represent a new concept for targeted anticancer therapy This new antibody class has the capability to redirect T cells and accessory cells eg macrophages dendritic cells DCs and natural killer NK cells to the tumor site According to preclinical data trifunctional antibodies activate these different immune effector cells which can trigger a complex anti-tumor immune response
Catumaxomab is a trifunctional antibody targeting epithelial cell adhesion molecule EpCAM on tumor cells and CD3 cluster of differentiation 3 on T cells Trifunctional antibodies represent a new concept for targeted anticancer therapy This new antibody class has the capability to redirect T cells and accessory cells eg macrophages dendritic cells DCs and natural killer NK cells to the tumor site According to preclinical data trifunctional antibodies activate these different immune effector cells which can trigger a complex anti-tumor immune response
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