Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00189345
Status:
COMPLETED
Last Update Posted:
2006-11-08
First Post:
2005-09-12
Brief Title:
Randomized Multicenter 2-Dose Level Open-Label Phase IIa Study With the Intraperitoneally Infused Trifunctional Bispecific Antibody RemovabTM Anti-EpCAM x Anti-CD3 to Select the Better Dose Level in Platinum Refractory Epithelial Ovarian Cancer Patients
Sponsor:
AGO Study Group
Organization:
AGO Study Group
Study Overview
Official Title:
Randomized Multicenter 2-Dose Level Open-Label Phase IIa Study With the Intraperitoneally Infused Trifunctional Bispecific Antibody RemovabTM Anti-EpCAM x Anti-CD3 to Select the Better Dose Level in Platinum Refractory Epithelial Ovarian Cancer Patients
Status:
COMPLETED
Status Verified Date:
2003-12
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:
Patients with epithelial ovarian cancer fallopian tube or peritoneal cancer who receive surgical cytoreduction and platinumtaxane containing chemotherapy have a significant chance of entering complete clinical remission but about 70 will eventually relapse Many patients respond to additional cytotoxic treatment with partial or complete responses yet approximately 100 of these patients will ultimately progress Novel consolidation strategies following treatment for recurrent disease are needed and an immunologic approach is an attractive optionEpCAM is expressed in a large number of epithelial ovarian cancer fallopian tube or peritoneal cancer tissues Thus targeting these cancers with an anti-EpCAM antibody is a promising innovative therapeutic approach
Detailed Description:
None
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