Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2025-12-31 @ 5:06 PM
Study NCT ID:
NCT00352833
Status:
COMPLETED
Last Update Posted:
2007-10-26
First Post:
2006-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study With Catumaxomab in Patients After Curative Resection of a Gastric Adenocarcinoma
Sponsor:
Neovii Biotech
Organization:
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 1:1 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 i.p.-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 i.p.-infusion via a provided indwelling catheter on the days 7, 10, 13 and 16, respectively.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: