Phase 1/2a Study of DTA-H19 in Advanced Stage Ovarian Cancer
This study is designed to assess the safety, tolerability, pharmacokinetics (PK) and preliminary efficacy of DTA-H19 administered intraperitoneally (IP) in subjects with advanced stage ovarian cancer, or primary peritoneal carcinoma
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase 1/2a, Dose-Escalation, Safety, Pharmacokinetic, and Preliminary Efficacy Study of Intraperitoneal Administration of DTA-H19 in Subjects With Advanced Stage Ovarian Cancer|
- maximum tolerated dose of DTA-H19 given intraperitoneally [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
- Quality of Life [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
- progression-free survival [ Time Frame: 3 months and 1 year ] [ Designated as safety issue: No ]
- overall survival [ Time Frame: 3 months and 1 year ] [ Designated as safety issue: No ]
- time to progression [ Time Frame: 3 months and 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||June 2009|
|Study Completion Date:||October 2012|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
BC-819 60, 120 and 240 mg IP administration
Cohort #1: 60 mg IP weekly for 3 weeks, one week rest, then repeat for 2 more courses / 60 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.
Cohort #2: 120 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.
Cohort #3: 240 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.
Other Name: DTA-H19
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.
|The Edith Wolfson Medical Center|
|Hadassah University Hospital|
|Kfar Saba, Israel|
|Sheba Medical Center|
|Tel Hashomer, Israel|
|Principal Investigator:||Tally Levy, M.D.||The Edith Wolfson Medical Center|
|Principal Investigator:||David Edelman, MD||Hadassah University Hospital|
|Principal Investigator:||Ami Fishman, MD||Meir Medical Center|
|Principal Investigator:||Eitan Rami, MD.||Rabin Medical Center|
|Principal Investigator:||Ofer Lavie, M.D.||Carmel Medical Center|
|Principal Investigator:||Ronnie Shapira-Frommer, MD||Sheba Medical Center|