A Phase 1, Open Label, Dose Escalation Study of the Safety, Tolerability and Preliminary Efficacy of Intraperitoneal EGEN-001 in Patients With Recurrent Epithelial Ovarian Cancer
EGEN-001-101 is a Phase 1, open label, non-randomized, dose escalation study in up to 18
(eighteen) patients (three to six patients in each of the first three cohorts, and up to
nine patients in a fourth cohort or MTD). The fourth cohort (or MTD, if earlier) will be
expanded in increments of three patients until a total of 18 patients have been enrolled.
Each patient will provide written dated informed consent prior to undergoing eligibility
screening for entry into the study. Screening evaluations will be performed within 21 days
prior to scheduled study drug administration. If all eligibility criteria are met, the
patient will be enrolled and will be scheduled for placement of the IP catheter at least 7
days prior to the scheduled dosing (Day -7) to allow adequate time for healing around the
catheter insertion site. Baseline evaluations will be performed prior to dosing. At that
time the investigator will ensure that the patient remains eligible for participation.
All study drug will be administered on an inpatient basis and the patient will remain
confined for 24 hours following study drug administration for evaluation of safety and
collection of specified body fluid samples for plasmid IL-12-DNA and cytokine
determinations. Each patient will receive the same dose of EGEN-001 once weekly for four
weeks (administered on Day 0, Day 7, Day 14, and Day 21). Patients will undergo safety
evaluations 1, 4 and 24 hours and 3 days following each dose. Patients will return to the
clinic for safety evaluations three days, one week and five weeks (± one week) following the
last dose.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the maximum tolerated dose (MTD) and to assess the spectrum of toxicities of EGEN-001 when administered by intraperitoneal (IP) infusion in patients with recurrent epithelial ovarian cancer
Yes
Ronald Alvarez, MD
Principal Investigator
Divison of Gynecologic Oncology at University of Alabama at Birmingham
United States: Food and Drug Administration
EGEN-001-101
NCT00137865
August 2005
October 2006
Name | Location |
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University of Alabama at Birmingham | Birmingham, Alabama 35294-3300 |