A Randomized, Phase 2, Open-label Study Evaluating DN24-02 as Adjuvant Therapy in Subjects With High Risk HER2+ Urothelial Carcinoma
This is a multicenter, open-label, Phase 2 study. Subjects will be randomized to either the
investigational product, DN24-02, or to standard of care. The purpose of this study is to
compare the length of survival between these 2 groups of subjects. Other purposes of the
study are to learn about the safety of DN24-02, to learn if it delays the time until
urothelial cancer recurs, and to learn if the immune system responds to treatment with
DN24-02. All subjects will be followed for this study for the remainder of their lives.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluate overall survival following administration of DN24-02
Subjects will be followed from baseline through the remainder of their lives or until study completion (approximately 5 years)
No
Robert Sims, MD
Study Chair
Dendreon
United States: Food and Drug Administration
N10-1
NCT01353222
June 2011
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Mayo Clinic | Rochester, Minnesota 55905 |
USC/Norris Comprehensive Cancer Center | Los Angeles, California 90033-0800 |
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
Mount Sinai School of Medicine | New York, New York 10029 |
Virginia Mason Medical Center | Seattle, Washington 98111 |
University of Rochester Medical Center | Rochester, New York 14642 |
City of Hope Medical Center | Duarte, California 91010 |
Vanderbilt University Medical Center | Nashville, Tennessee 37232-2516 |
Mayo Clinic Hospital | Phoenix, Arizona 85054-4502 |
Michigan Institute of Urology | Detroit, Michigan 48236 |
University of Minnesota | Minneapolis, Minnesota 55455 |
Duke University | Durham, North Carolina 27710 |
University of Chicago Medical Center | Chicago, Illinois 60637 |
Thomas Jefferson University | Philadelphia, Pennsylvania 19107-6541 |
Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
Lahey Clinic | Burlington, Massachusetts 01805 |
Urological Associates Of Lancaster | Lancaster, Pennsylvania 17604-3200 |
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231 |
Jewish Hospital | Cincinnati, Ohio 45236 |
Indiana University | Indianapolis, Indiana 46202 |
Mayo Clinic Arizona | Scottsdale, Arizona 85259 |
University of Kansas Cancer Center | Kansas City, Kansas 66160 |
Columbia University Medical Center | New York, New York 10032 |
Johns Hopkins Hospital | Baltimore, Maryland 21287 |
The University of Texas MD Anderson Cancer Center | Houston, Texas 77030-4009 |
Memorial Sloan Kettering | New York, New York 10021 |
Oregon Urology Institute | Springfield, Oregon 97477 |
Stanford University Hospital | Stanford, California 94303 |
University of Miami Cancer Center | Miami, Florida 33136 |
The Urology Center of Colorado | Denver, Colorado 80211 |
Providence Medical Center | Portland, Oregon 97213 |
H. Lee Moffitt Cancer Center & Research Institute, Inc. | Tampa, Florida 33612 |
University of Wisconsin Carbone Cancer Center | Madison, Wisconsin 53792-5669 |
Mount Sinai School of Medicine Department of Urology | New York, New York 10029 |
Urological Research Network | Hialeah, Florida 33016 |
Urology Health Specialists, LLC | Bryn Mawr, Pennsylvania 19010 |
Genesis Research | San Diego, California 92123 |
Associated Medical Professionals of New York, PLLC | Oneida, New York 13421 |
TriState Urologic Services PSC, Inc. dba TUG Research | Cincinnati, Ohio 45212 |
Urology Associates, P.C. | Nashville, Tennessee 37209 |
Kansas City Urology Care | Overland Park, Kansas 66211 |
Dana-Farber Cancer Institute - The Lank Center for Genitourinary Oncology | Boston, Massachusetts 02215 |
Sentara Leigh Hospital | Norfolk, Virginia 23502 |
Urology of Virginia, PLLC | Virginia Beach, Virginia 23462 |
University of Colorado, Anschutz Cancer Pavilion | Aurora, Colorado 80045 |
Neag Comprehensive Cancer Center/University of Connecticut Health Center | Farmington, Connecticut 06030 |
Emory Department of Urology, The Emory Clinic Inc, Emory University Hospital | Atlanta, Georgia 30322 |
American Red Cross | Atlanta, Georgia 30324 |
GU Research Center, LLC | Omaha, Nebraska 68130 |
John Theurer Cancer Center, Hackensack University Medical Center | Hackensack, New Jersey 07601 |
NYU Clinical Cancer Center, NYU Langone Medical Center | New York, New York 10016 |
Associated Medical Professionals of NY, PLLC | Oneida, New York 13421 |
UNC Health Care, NC Cancer Hospital | Chapel Hill, North Carolina 27514 |
Hoxworth Blood Center | Cincinnati, Ohio 45219 |
OHSU Knight Cancer Institute Hematology Oncology | Beaverton, Oregon 97006 |