Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00352833
Status:
COMPLETED
Last Update Posted:
2007-10-26
First Post:
2006-07-14
Brief Title:
Safety and Efficacy Study With Catumaxomab in Patients After Curative Resection of a Gastric Adenocarcinoma
Sponsor:
Neovii Biotech
Organization:
Neovii Biotech
Study Overview
Official Title:
Multicenter Open-Label and Randomized Phase II Study to Evaluate Safety and Efficacy of the Trifunctional Bispecific Antibody Catumaxomab Anti-EpCAM x Anti-CD3 in Patients After Curative Resection of a Confirmed Gastric Adenocarcinoma Compared With Surgery Alone
Status:
COMPLETED
Status Verified Date:
2007-06
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:
Investigation of the outcome of an adjuvant treatment with catumaxomab as compared to surgery alone in patients after curative resection of a gastric adenocarcinoma in order to gain more detailed information primary on safety tolerability and feasibility and secondary on relevant efficacy parameters
Detailed Description:
A controlled randomized open-label multi-center parallel-group Phase II study to generate valid hypotheses on safety and efficacy issues in patients with a primary confirmed diagnosis of gastric adenocarcinoma and a high risk of disseminated tumor cells due to serosal infiltration after curative gastrectomy Eligible patients will be centrally randomized by IVRS during operation to one of the two study groups in an 11 ratio surgery plus catumaxomab or surgery alone
Treatment with catumaxomab will consist of an initial dose of 10 µg given intraoperatively as an intraperitoneal bolus on day 0 and of four following ascending doses 10-20-50-150 µg which will be administered as an ip-infusion via a provided indwelling catheter on the days 7 10 13 and 16 respectively
Treatment with catumaxomab will consist of an initial dose of 10 µg given intraoperatively as an intraperitoneal bolus on day 0 and of four following ascending doses 10-20-50-150 µg which will be administered as an ip-infusion via a provided indwelling catheter on the days 7 10 13 and 16 respectively
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