Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00473954
Status:
COMPLETED
Last Update Posted:
2013-03-26
First Post:
2007-05-15
Brief Title:
Safety and Efficacy of EGEN-001 Combined With Carboplatin and Docetaxel in Recurrent Platinum-Sensitive Ovarian Cancer
Sponsor:
EGEN Inc
Organization:
EGEN Inc
Study Overview
Official Title:
A Phase 1 Open-Label Dose Escalation Study of the Safety and Preliminary Efficacy of EGEN-001 in Combination With Carboplatin and Docetaxel in Women With Recurrent Platinum-Sensitive Epithelial Ovarian Cancer
Status:
COMPLETED
Status Verified Date:
2013-03
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:
Ovarian cancer may be caused by a build-up of genetic defects or damaged genes within the bodys cells When genes are damaged the body may be unable to produce a group of proteins called cytokines used by the immune system to fight cancer and some infections The investigational gene transfer agent EGEN-001 contains the human gene for the cytokine interleukin-12 IL-12 in a special carrier system designed to enter the cells and help the body to produce cytokines Therefore the purpose of the EGEN-001 therapy is to attempt to enhance the bodys natural ability to recognize and fight cancer cells Funding Source - FDA OOPD
Detailed Description:
This study has two purposes
To determine what different strengths and number of doses of EGEN-001 administered directly into the peritoneal cavity can be given safely in combination with standard intravenous chemotherapy for ovarian cancer
To evaluate the anti-cancer activity of EGEN-001 when combined with standard chemotherapy biological markers of EGEN-001 activity will be collected and ovarian cancer burden will be evaluated per standard practice
To determine what different strengths and number of doses of EGEN-001 administered directly into the peritoneal cavity can be given safely in combination with standard intravenous chemotherapy for ovarian cancer
To evaluate the anti-cancer activity of EGEN-001 when combined with standard chemotherapy biological markers of EGEN-001 activity will be collected and ovarian cancer burden will be evaluated per standard practice
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