drugset / Trial / NCT00473954
Safety and Efficacy of EGEN-001 Combined With Carboplatin and Docetaxel in Recurrent, Platinum-Sensitive, Ovarian Cancer
Non-randomizedSingle-groupOpen-labelTreatment
Summary
Ovarian cancer may be caused by a build-up of genetic defects, or damaged genes within the body's 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 body's natural ability to recognize and fight cancer cells. Funding Source - FDA OOPD
Timeline
- Start
- 2007-04
- Primary completion
- 2009-11
- Completion
- 2009-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | EGEN-001 | Other / unclassified | 12 mg/m2 | Other |
| Subject | EGEN-001 | Other / unclassified | 18 mg/m2 | Other |
| Subject | EGEN-001 | Other / unclassified | 24 mg/m2 | Other |
| Background | Carboplatin | Small molecule | — | Intravenous |
| Background | Docetaxel | Small molecule | — | Intravenous |