A Phase I study of the safety of intraperitoneal EGEN-001 (IL-12 plasmid formulated with PEG-PEI-Cholesterol lipopolymer) administered in combination with pegylated liposomal doxorubicin (PLD) in recurrent ovarian cancer patients. The purpose of this studtermine the safety of EGEN-001 IP plus PLD treatment in platinum-recurrent ovarian cancer patients.
Principal Investigator
Ronald Alvarez, MD
Status
Terminated
Date Opened To Accrual
July 09 2012
Date Closed to Accrual
April 27 2015
Date of Study Termination
January 27 2018
Disease Site
Gynecologic [GY]
Ovarian
Phase
I
Developmental Therapeutics
No
Primary Objective
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.
To examine the tolerability of the combination at the MTD of EGEN-001 assessed in combination with PLD.
To determine recommended phase II dose (RP2D) of EGEN-001 in combination with PLD.
Patient Population
Women with recurrent or persistent, epithelial ovarian, fallopian tube or primary peritoneal cancer.
Target Accrual
18
Patient Study Webpage
There is no available patient study webpage available for this trial at this time.