Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00326885
Status:
COMPLETED
Last Update Posted:
2018-10-17
First Post:
2006-05-15
Brief Title:
Study of the Trifunctional Antibody Catumaxomab to Treat Recurrent Symptomatic Malignant Ascites
Sponsor:
Neovii Biotech
Organization:
Neovii Biotech
Study Overview
Official Title:
A Single-Arm Open-Label Phase II Study to Assess the Safety and Efficacy of the Trifunctional Antibody Catumaxomab Anti-EpCAM x Anti-CD3 Administered Intraperitoneally in Ovarian Cancer Patients With Recurrent Symptomatic Malignant Ascites
Status:
COMPLETED
Status Verified Date:
2018-09
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 is a safe and effective treatment for recurrent symptomatic malignant ascites
Detailed Description:
A multi-center phase II study of catumaxomab in ovarian cancer patients with recurrent symptomatic malignant ascites requiring therapeutic paracentesis Each eligible patient will receive four ascending doses of catumaxomab administered intraperitoneally via an indwelling catheter 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 7 months includes the baseline therapeutic paracentesis and screening period 11 to 21 days treatment period and up to 180 days6 months follow-up with monthly post-study follow-up for the lifetime of the patient
Catumaxomab is a trifunctional antibody targeting EpCAM on tumor cells and CD3 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 EpCAM on tumor cells and CD3 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