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Sponsored by: |
BioCancell Therapeutics Ltd |
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Information provided by: | BioCancell Therapeutics Ltd |
ClinicalTrials.gov Identifier: | NCT00826150 |
This study is designed to assess the safety, tolerability, pharmacokinetics (PK) and preliminary efficacy for ascites palliation of DTA-H19 administered intraperitoneally (IP) in subjects with advanced stage ovarian cancer who have evidence of symptomatic ascites
Condition | Intervention | Phase |
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Ovarian Cancer |
Biological: DTA-H19 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 12 |
Study Start Date: | June 2009 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
This is a Phase 1/2a, open label, dose escalation, repeat dose study in 12 subjects with recurrent, platinum resistant advanced stage ovarian cancer 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:
Secondary Objectives: Secondary objectives of this study are:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Pennsylvania | |
University of Pennsylvania Medical Center | Recruiting |
Philadelphia, Pennsylvania, United States, 19104-6142 | |
Contact: Lana E. Kandalaft, Pharm.D, PhD 215-573-4782 lknd@mail.med.upenn.edu | |
Principal Investigator: George Coukos, M.D., Ph.D. | |
United States, Virginia | |
Massey Cancer Center | Not yet recruiting |
Richmond, Virginia, United States, 23298-0037 | |
Contact: Jane W. Baggett, RN 804-628-2360 jbaggett@mcvh-vcu.edu | |
Principal Investigator: Cecelia H. Boardman, M.D. | |
Israel | |
The Edith Wolfson Medical Center | Recruiting |
Holon, Israel | |
Contact: Pnina Nir (972)-52-8445143 pninanir@wolfson.health.gov.il | |
Principal Investigator: Tally Levy, M.D. | |
Hadassah University Hospital | Recruiting |
Jerusalem, Israel | |
Contact: Zoya Bezalel (972)-2-6776725 zoyab@hadassah.org.il | |
Principal Investigator: David Edelman, MD | |
Meir Hospital | Recruiting |
Kfar Saba, Israel | |
Contact: Tal Naderi 09-7472213 Ta.INadiri@clalit.org.il | |
Principal Investigator: Ami Fishman, MD |
Principal Investigator: | George Coukos, M.D., Ph.D. | University of Pennsylvania Medical Center |
Principal Investigator: | Tally Levy, M.D. | The Edith Wolfson Medical Center |
Principal Investigator: | Cecelia H. Boardman, M.D. | Massey Cancer Center |
Principal Investigator: | David Edelman, MD | Hadassah University Hospital |
Principal Investigator: | Ami Fishman, MD | Meir Medical Center |
Responsible Party: | BioCancell Therapeutics Ltd. ( Patricia Ohana, Ph.D. ) |
Study ID Numbers: | BC-08-01 |
Study First Received: | January 18, 2009 |
Last Updated: | August 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00826150 History of Changes |
Health Authority: | United States: Food and Drug Administration; Israel: Ministry of Health |
ovarian cancer H19 gene plasmid |
Genital Diseases, Female Ovarian Neoplasms Gonadal Disorders Ascites Genital Neoplasms, Female Ovarian Cancer |
Endocrine System Diseases Urogenital Neoplasms Endocrinopathy Ovarian Diseases Endocrine Gland Neoplasms |
Genital Diseases, Female Neoplasms Neoplasms by Site Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female |
Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Adnexal Diseases Endocrine Gland Neoplasms |