Study Of Intraperitoneal EGEN-001 Administered In Combination With Pegylated Liposomal-Doxorubicin In Patients With Recurrent Or Persistent Epithelial Ovarian Fallopian Tube Or Peritoneal Cancer
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- STATUS
- Recruiting
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- participants needed
- 18
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- sponsor
- EGEN, Inc.
Summary
Pegylated liposomal doxorubicin (PLD; e.g., Doxil®, Lipodox™) will be administered intravenously on Day 1 and EGEN-001 will be administered intraperitoneally on Day 1, 8, 15, and 22 of a 28-day cycle to determine: - The maximum tolerated dose (MTD) and dose limiting toxicities (DLTs) of EGEN-001 when administered in combination with pegylated liposomal doxorubicin (PLD; Doxil®, Lipodox™), every 28 days and the associated DLTs based on adverse events that occur in cycle 1 for this combination in women with recurrent or persistent, epithelial ovarian, fallopian tube or primary peritoneal cancer. - The tolerability of the combination at the MTD of EGEN-001 assessed in combination with PLD. - The recommended phase II dose (RP2D) of EGEN-001 in combination with PLD.
Details
| Condition | Fallopian Tube Cancer |
|---|---|
| Treatment | EGEN-001 (IL-12 PLASMID FORMULATED WITH LIPOPOLYMER), Pegylated Liposomal Doxorubicin (PLD), Doxil And Lipodox |
| Clinical Study Identifier | NCT01673477 |
| Sponsor | EGEN, Inc. |
| Last Modified on | 8 November 2020 |
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