Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00050375
Status:
TERMINATED
Last Update Posted:
2007-12-18
First Post:
2002-12-05
Brief Title:
Clinical Trial for Ovarian Cancer OvaRex
Sponsor:
Unither Pharmaceuticals
Organization:
Unither Pharmaceuticals
Study Overview
Official Title:
A Double-Blind Placebo-Controlled Multicenter Clinical Trial of Intravenous OvaRex MAb-B4313 as Post Chemotherapy Consolidation for Epithelial Carcinoma of Ovarian Tubal or Peritoneal Origin
Status:
TERMINATED
Status Verified Date:
2006-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study closed by sponser
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will compare the time to disease relapse between OvaRex MAb-B4313-treated patients and placebo-treated patients This study will also compare assessments of survival quality of life immune response and safety between active and placebo groups
Detailed Description:
This a Phase III double-blind placebo-controlled multi-center study of intravenous OvaRex MAb-B4313 as post-chemotherapy consolidation for epithelial carcinoma of ovarian tubal or peritoneal origin
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