Spots Global Cancer Trial Database for DN24-02 as Adjuvant Therapy in Subjects With High Risk HER2+ Urothelial Carcinoma
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Trial Identification
Brief Title: DN24-02 as Adjuvant Therapy in Subjects With High Risk HER2+ Urothelial Carcinoma
Official Title: A Randomized, Phase 2, Open-label Study Evaluating DN24-02 as Adjuvant Therapy in Subjects With High Risk HER2+ Urothelial Carcinoma
Study ID: NCT01353222
Conditions
Study Description
Brief Summary: This study was conducted to examine survival, disease-free survival, safety, and the magnitude of the immune response induced following administration of DN24-02 in subjects with HER2+ urothelial carcinoma.
Detailed Description: Multicenter, open-label, Phase 2 study. Subjects were randomized to either the investigational product, DN24-02, or to standard of care. Subjects randomized to the experimental arm received DN24-02 at 2-week intervals, for a total of 3 infusions. The study evaluated survival, disease-free survival, safety and the magnitude of the immune response between these 2 subject groups.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic Hospital, Phoenix, Arizona, United States
Mayo Clinic Arizona, Scottsdale, Arizona, United States
City of Hope Medical Center, Duarte, California, United States
USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States
Genesis Research, San Diego, California, United States
Stanford University Hospital, Stanford, California, United States
University of Colorado, Anschutz Cancer Pavilion, Aurora, Colorado, United States
The Urology Center of Colorado, Denver, Colorado, United States
Neag Comprehensive Cancer Center/University of Connecticut Health Center, Farmington, Connecticut, United States
Yale University School of Medicine, New Haven, Connecticut, United States
Urological Research Network, Hialeah, Florida, United States
University of Miami Cancer Center, Miami, Florida, United States
H. Lee Moffitt Cancer Center & Research Institute, Inc., Tampa, Florida, United States
Emory Department of Urology, The Emory Clinic Inc, Emory University Hospital, Atlanta, Georgia, United States
American Red Cross, Atlanta, Georgia, United States
University of Chicago Medical Center, Chicago, Illinois, United States
Indiana University, Indianapolis, Indiana, United States
Kansas City Urology Care, Overland Park, Kansas, United States
University of Kansas Cancer Center, Westwood, Kansas, United States
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
Johns Hopkins Hospital, Baltimore, Maryland, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Lahey Clinic, Burlington, Massachusetts, United States
Michigan Institute of Urology, Troy, Michigan, United States
University of Minnesota, Minneapolis, Minnesota, United States
Mayo Clinic, Rochester, Minnesota, United States
GU Research Center, LLC, Omaha, Nebraska, United States
John Theurer Cancer Center, Hackensack University Medical Center, Hackensack, New Jersey, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
NYU Clinical Cancer Center, NYU Langone Medical Center, New York, New York, United States
Memorial Sloan Kettering, New York, New York, United States
Mount Sinai School of Medicine Department of Urology, New York, New York, United States
Mount Sinai School of Medicine, New York, New York, United States
Columbia University Medical Center, New York, New York, United States
Weill Cornell Medical College, New York, New York, United States
Associated Medical Professionals of NY, PLLC, Oneida, New York, United States
University of Rochester Medical Center, Rochester, New York, United States
Associated Medical Professionals of New York, PLLC, Syracuse, New York, United States
UNC Health Care, NC Cancer Hospital, Chapel Hill, North Carolina, United States
Duke University, Durham, North Carolina, United States
TriState Urologic Services PSC, Inc. dba TUG Research, Cincinnati, Ohio, United States
Hoxworth Blood Center, Cincinnati, Ohio, United States
Jewish Hospital, Cincinnati, Ohio, United States
The Ohio State University Wexner Medical Center, James Cancer Hospital, Martha Morehouse Medical Plaza, Ohio State University Dept of Urology, Columbus, Ohio, United States
Urologic Specialists of Oklahoma, Tulsa, Oklahoma, United States
OHSU Knight Cancer Institute Hematology Oncology, Beaverton, Oregon, United States
Providence Medical Center, Portland, Oregon, United States
Oregon Urology Institute, Springfield, Oregon, United States
Urology Health Specialists, LLC, Bryn Mawr, Pennsylvania, United States
Thomas Jefferson University, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Medical University of South Carolina, Charleston, South Carolina, United States
Urology Associates, P.C., Nashville, Tennessee, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Sentara Leigh Hospital, Norfolk, Virginia, United States
Urology of Virginia, PLLC, Virginia Beach, Virginia, United States
Virginia Mason Medical Center, Seattle, Washington, United States
UW Medical Center, Seattle, Washington, United States
University of Wisconsin Carbone Cancer Center, Madison, Wisconsin, United States
Contact Details
Name: Robert Israel, MD
Affiliation: Valeant Pharmaceuticals North America LLC
Role: STUDY_DIRECTOR
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