Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00034372
Status:
TERMINATED
Last Update Posted:
2007-12-18
First Post:
2002-04-26
Brief Title:
Multicenter Clinical Trial of Intravenous OvaRex MAb-B4313 as Post-Chemotherapy Consolidation for Ovarian Carcinoma
Sponsor:
Unither Pharmaceuticals
Organization:
Unither Pharmaceuticals
Study Overview
Official Title:
None
Status:
TERMINATED
Status Verified Date:
2007-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
closed by sponser
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this study patients will be randomized to one of three dose regimen groups Each dose of OvaRex MAb-B4313 is 2 mg by slow intravenous administration
Group 1 will receive two doses one month apart
Group 2 will receive three consecutive monthly doses then at 12-week intervals through 2 years or until disease relapse up to a total of 9 doses
Group 3 will receive six consecutive monthly doses then at 12-week intervals through 2 years or until disease relapse up to a total of 11 doses
The study will compare the time to disease relapse of patients who demonstrate an immune response to OvaRex MAb-B4313 with time to disease relapse of those who do not demonstrate an immune response to OvaRex MAb-B4313 Differences in the percentage of patients demonstrating an immune response in each dose regimen group will also be assessed
Group 1 will receive two doses one month apart
Group 2 will receive three consecutive monthly doses then at 12-week intervals through 2 years or until disease relapse up to a total of 9 doses
Group 3 will receive six consecutive monthly doses then at 12-week intervals through 2 years or until disease relapse up to a total of 11 doses
The study will compare the time to disease relapse of patients who demonstrate an immune response to OvaRex MAb-B4313 with time to disease relapse of those who do not demonstrate an immune response to OvaRex MAb-B4313 Differences in the percentage of patients demonstrating an immune response in each dose regimen group will also be assessed
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