Phase 1/2a, Dose-Escalation, Safety, Pharmacokinetic, and Preliminary Efficacy Study of Intraperitoneal Administration of DTA-H19 in Subjects With Advanced Stage Ovarian Cancer
This is a Phase 1/2a, open label, dose escalation, repeat dose study in 11 subjects with
recurrent, platinum resistant advanced stage ovarian cancer or primary peritoneal carcinoma
designed to determine the tolerability, safety, quality of life, PK, and preliminary
efficacy of DTA-H19 administered intraperitoneally(IP).
Primary Objective: The primary objectives of this study are:
- To determine the maximum tolerated dose (MTD) of IP DTA-H19; and,
- To identify any dose limiting toxicities (DLTs).
Secondary Objectives: Secondary objectives of this study are:
- To determine quality of life of subjects with advanced ovarian cancer, primary
peritoneal carcinoma treated with IP DTA-H19;
- To determine the the reduction in malignant ascites as measured by Ultrasound and
change in frequency of parecenteses necessary.
- To determine the overall survival distribution.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
maximum tolerated dose of DTA-H19 given intraperitoneally
Tally Levy, M.D.
The Edith Wolfson Medical Center
United States: Food and Drug Administration