Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00464893
Status:
COMPLETED
Last Update Posted:
2013-12-04
First Post:
2007-04-23
Brief Title:
Phase II Study With Catumaxomab in Patients With Gastric Cancer After Neoadjuvant CTx and Curative Resection
Sponsor:
Neovii Biotech
Organization:
Neovii Biotech
Study Overview
Official Title:
Multicenter Open-label Phase II Study to Evaluate the Safety and Efficacy of the Trifunctional Bispecific Antibody Catumaxomab Anti-EpCAM x Anti-CD3 in Patients With Gastric Adenocarcinoma After Neoadjuvant Chemotherapy and Intended Curative Resection
Status:
COMPLETED
Status Verified Date:
2013-12
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:
Primary evaluation of the safety tolerability and feasibility regarding specific postoperative complications of an adjuvant treatment with catumaxomab administered after curative tumor resection subsequent to a neoadjuvant chemotherapy
Detailed Description:
An open-label multi-center phase II study in surgically resectable patients after neoadjuvant ECX-chemotherapy with confirmed diagnosis of gastric adenocarcinoma and with a high risk of disseminated tumor cells due to serosal infiltration or positive lymph nodes after curative gastrectomy
Treatment with catumaxomab will consist of an initial dose of 10 µg given intraoperatively as an intraperitoneal bolus and of four postoperative ascending doses 10-20-50-150 µgwhich will be administered as an ip-infusion using an installed abdominal ip-port on the postoperative days 7 10 13 and 16
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
Treatment with catumaxomab will consist of an initial dose of 10 µg given intraoperatively as an intraperitoneal bolus and of four postoperative ascending doses 10-20-50-150 µgwhich will be administered as an ip-infusion using an installed abdominal ip-port on the postoperative days 7 10 13 and 16
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EudraCT-Nr2006-002727-16 | None | None | None |