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Sponsored by: |
Viventia Biotech |
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Information provided by: | Viventia Biotech |
ClinicalTrials.gov Identifier: | NCT00462488 |
The purpose of this study is to evaluate the efficacy and tolerability of Vicinium when administered as a monotherapy intravesical instillation in patients with non-invasive urothelial carcinoma in situ (CIS) who failed previous treatment with Bacille Calmette Guérin (BCG).
Condition | Intervention | Phase |
---|---|---|
Urinary Bladder Cancer Bladder Cancer Bladder Neoplasms Bladder Tumors |
Drug: Vicinium |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Study to Evaluate the Efficacy and Tolerability of Intravesical Vicinium™ in Patients With Non-Invasive Urothelial Carcinoma in Situ (CIS) Previously Treated With Bacille Calmette-Guérin (BCG) |
Enrollment: | 46 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | November 2009 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Disease Characteristics
Prior/Concurrent Therapy
Patient Characteristics
The patient must have adequate organ function, as defined by the clinical trial protocol
Other
Exclusion Criteria:
United States, Florida | |
Southeastern Research Group, Inc. | |
Tallahassee, Florida, United States, 32308 | |
United States, Maryland | |
Johns Hopkins Medical Institutions | |
Baltimore, Maryland, United States, 21287 | |
United States, New Jersey | |
Lawrenceville Urology | |
Lawrenceville, New Jersey, United States, 08648 | |
United States, North Carolina | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27710 | |
United States, Oregon | |
Oregon Urology Institute Research | |
Springfield, Oregon, United States, 97477 | |
United States, South Carolina | |
Grand Strand Urology | |
Myrtle Beach, South Carolina, United States, 29572 | |
United States, Texas | |
Corpus Christi Urology Group, LLP | |
Corpus Christi, Texas, United States, 78404 | |
United States, Virginia | |
Urology of Virginia | |
Newport News, Virginia, United States, 23606 | |
Canada, British Columbia | |
Andreou Research | |
Surrey, British Columbia, Canada, V3V 1N1 | |
Can-Med Clinical Research Inc. | |
Victoria, British Columbia, Canada, V8T 5G9 | |
Canada, Ontario | |
The Male/Female Health and Research Centre, Royal Court Medical Centre | |
Barrie, Ontario, Canada, L4M 7G1 | |
Princess Margaret Hospital | |
Toronto, Ontario, Canada, M5G 2M9 | |
The Scarborough Hospital | |
Scarborough, Ontario, Canada, M1P 2T7 | |
London Health Sciences Centre | |
London, Ontario, Canada, N6A 4G5 | |
Centre for Applied Urological Research | |
Kingston, Ontario, Canada, K7L 2V7 | |
McMaster University, Institute of Urology at Saint Joseph's Hospital | |
Hamilton, Ontario, Canada, L8N 4A6 | |
University of Toronto, Sunnybrook Health Sciences Centre | |
Toronto, Ontario, Canada, M4N 3M5 | |
The Fe/Male Health Centre | |
Oakville, Ontario, Canada, L6H 3P1 | |
Urology Resource Centre | |
Burlington, Ontario, Canada, L7S 1V2 | |
Todd Webster, M.D. | |
Owen Sound, Ontario, Canada, N4K 2J1 | |
Canada, Quebec | |
Centre Hospitalier Universitaire de Sherbrooke, Hopital Fleuimont | |
Sherbrooke, Quebec, Canada, J1H 5N4 |
Study Director: | Wendy Cuthbert | Viventia Biotech |
Responsible Party: | Viventia Biotech Inc. ( Wendy Cuthbert, Chief Operating Officer ) |
Study ID Numbers: | VB4-845-02-IIA |
Study First Received: | April 17, 2007 |
Last Updated: | September 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00462488 |
Health Authority: | Canada: Health Canada; United States: Food and Drug Administration |
Cystocele Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Neoplasms Carcinoma, Transitional Cell Urologic Neoplasms Transitional cell carcinoma |
Carcinoma Urologic Diseases Carcinoma in Situ Urinary tract neoplasm Neoplasms, Glandular and Epithelial Bladder neoplasm |
Neoplasms Neoplasms by Histologic Type Neoplasms by Site |