Phase 1/2a Study of DTA-H19 in Advanced Stage Ovarian Cancer
|ClinicalTrials.gov Identifier: NCT00826150|
Recruitment Status : Completed
First Posted : January 21, 2009
Last Update Posted : November 14, 2012
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Biological: BC-819||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||October 2012|
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
- maximum tolerated dose of DTA-H19 given intraperitoneally [ Time Frame: 8 weeks ]
- Quality of Life [ Time Frame: 12 Weeks ]
- progression-free survival [ Time Frame: 3 months and 1 year ]
- overall survival [ Time Frame: 3 months and 1 year ]
- time to progression [ Time Frame: 3 months and 1 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00826150
|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|