Spots Global Cancer Trial Database for Codex: Study of Inodiftagene Vixteplasmid (BC-819) in Unresponsive NMIBC
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Trial Identification
Brief Title: Codex: Study of Inodiftagene Vixteplasmid (BC-819) in Unresponsive NMIBC
Official Title: A Phase 2 Study of BC-819 in Patients With Non-Muscle Invasive Bladder Cancer Whose Disease is Unresponsive to Bacillus Calmette-Guerin
Study ID: NCT03719300
Interventions
Study Description
Brief Summary: This study, BC-819-18-204, is a Phase 2, open-label, monotherapy, single-arm, multicenter clinical trial of BC-819 (inodiftagene vixteplasmid) in patients with NMIBC adequately treated with Bacillus Calmette-Guerin (BCG) whose disease is BCG unresponsive according to the US Food and Drug Administration (FDA) guidance.
Detailed Description: BC-819 (inodiftagene vixteplasmid) is a recombinant DNA plasmid that directs the expression of a potent toxin specifically in malignant cells but not in normal tissue. It has been designed to exploit the established biology of the H19 gene, which is upregulated and expressed at high levels only in malignant cells, to produce bacterial diphtheria toxin only in bladder cancer tissue. BC-819 is administered directly into the bladder to enable maximal topical exposure to target bladder cancer cells.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Alaska Urological Institute, Anchorage, Alaska, United States
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
Mayo Clinic Arizona, Phoenix, Arizona, United States
Urological Associates of Southern Arizona, Tucson, Arizona, United States
Arkansas Urology, Little Rock, Arkansas, United States
American Institute of Research, Los Angeles, California, United States
UC Davis Medical Center, Sacramento, California, United States
The Urology Center of Colorado, Denver, Colorado, United States
Mayo Clinic Florida, Jacksonville, Florida, United States
University of Florida Health Jacksonville, Shands Hospital, Jacksonville, Florida, United States
Emory University, Atlanta, Georgia, United States
North Idaho Urology, Coeur d'Alene, Idaho, United States
Idaho Urologic Institute, PA, Meridian, Idaho, United States
University of Illinois Hospital and Health Systems (Outpatient Care Center), Chicago, Illinois, United States
The University of Kansas Cancer Center, Westwood, Kansas, United States
Wichita Urology Group, Wichita, Kansas, United States
Tulane University School of Medicine, New Orleans, Louisiana, United States
Ochsner Clinical Foundation, New Orleans, Louisiana, United States
Johns Hopkins Medical Institution, Baltimore, Maryland, United States
Spectrum Health Medical Group, Grand Rapids, Michigan, United States
Michigan Institute of Urology, PC, Troy, Michigan, United States
Mayo Clinic, Rochester, Minnesota, United States
Saint Louis University, Saint Louis, Missouri, United States
Washington University, Saint Louis, Missouri, United States
New Jersey Urology, LLC, Belleville, New Jersey, United States
MD Anderson Cancer Center at Cooper, Voorhees, New Jersey, United States
Albany Medical College, Albany, New York, United States
Montefiore Medical Center, Bronx, New York, United States
Weill Cornell Medical College - NY Presbyterian Hospital, New York, New York, United States
SUNY Upstate Medical University, Syracuse, New York, United States
UNC Chapel Hill Hospital, Urology Clinic, Chapel Hill, North Carolina, United States
Duke University, Durham, North Carolina, United States
Alliance Urology Specialists, PA, Greensboro, North Carolina, United States
Carolina Urology Partners, PLLC, Huntersville, North Carolina, United States
University of Toledo, Dept. of Urology and Kidney Transplant, Toledo, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
MidLantic Urology, Bala-Cynwyd, Pennsylvania, United States
The Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
Medical University South Carolina, Charleston, South Carolina, United States
Regional Urology, Greenville, South Carolina, United States
Urology Associates, P.C., Nashville, Tennessee, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
Baylor College of Medicine Medical Center, Houston, Texas, United States
The Methodist Hospital d/b/a Houston Methodist Hospital, Houston, Texas, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Virginia Urology, Richmond, Virginia, United States
Urology of Virginia, Virginia Beach, Virginia, United States
West Virginia University Cancer Institute, Morgantown, West Virginia, United States
Contact Details
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