Phase II Randomized Double Blind Placebo-Controlled Study to Determine the Efficacy of ABR-215050 in Asymptomatic Patients With Metastatic Castrate-Resistant Prostate Cancer
For asymptomatic patients with Castrate-Resistant Prostate Cancer (CRPC), a "window of
opportunity" is present. During this "window of opportunity" an intervention with little or
no toxicity and the potential for extending the "symptom-free" period would be of great
value to keep metastatic patients in an asymptomatic stage and thus delay the introduction
of chemotherapy. The purpose of this study is to evaluate the safety and efficacy of
ABR-215050 as an interventional agent for this role.
Overall survival for patients participating in study 07TASQ08 will be evaluated
retrospectively using a separate study protocol 11TASQ11.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Disease progression, defined as onset of tumor-related cancer pain, measurable disease progression, bone metastases or other non-target lesions, need for radiotherapy or surgery for pathological fracture or spinal cord compression
3 months, 6 months; continuation phase every 3 months
No
Goran Forsberg, Assoc. Prof.
Study Director
Active Biotech AB
United States: Food and Drug Administration
07TASQ08
NCT00560482
December 2007
July 2012
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Porter Adventist Hospital | Denver, Colorado 80210 |
Beth Israel Medical Center | New York, New York 10003 |
Southern California Permanente Medical Group | Downey, California 90242 |
Virginia Oncology Associates | Newport News, Virginia 23606 |
Galesburg Cottage Hospital | Galesburg, Illinois 61401 |
Vanderbilt University Medical Center | Nashville, Tennessee 37232-2516 |
Evanston Northwestern Healthcare | Evanston, Illinois 60201 |
Wake Urological Associates | Raleigh, North Carolina 27607 |
Duke University Medical Center | Durham, North Carolina 27710 |
North Idaho Urology | Couer D'Alene, Idaho 83814 |
Pacific Clinical Research | Santa Monica, California 90404 |
M.D. Anderson Cancer Center | Houston, Texas 77030 |
University of Chicago | Chicago, Illinois 60637 |
Urological Associates Of Lancaster | Lancaster, Pennsylvania 17604-3200 |
San Bernardino Urological Associates | San Bernardino, California |
Pacific Clinical Center | Encino, California 91316 |
Sharp Rees-Stealy | La Mesa, California 91942 |
Staten Island Urological Research, PC | Staten Island, New York 10304 |
Medical and Surgical Specialists | Galesburg, Illinois 61401 |
Urology Group of New Mexico | Albuquerque, New Mexico 87109 |
Johns Hopkins | Baltimore, Maryland 21231 |
Medical Oncology Associates - SD | San Diego, California 92123 |
Cancer Center Oncology Medical Group | La Mesa, California 91942 |
Seattle Urology Research Center | Burien, Washington |
AdvanceMed Research | Lawrenceville, New Jersey 08648 |
Alaska Clinical Research Center LLC | Anchorage, Alaska 99508 |
South County Hematology/Oncology | Chula Vista, California 91911 |
North County Oncology Medical Clinic, Inc. | Oceanside, California 92056 |
Urological Physicians of San Diego, Inc. | San Diego, California 92103 |
Sharp Memorial Hospital Investigational Pharmacy | San Diego, California 92123 |
Agajanian Institute of Oncology and Hematology | Whittier, California 90602 |
Urology Associates, PC | Denver, Colorado 80210 |
Diagnostic Professionals, Inc | Plantation, Florida 33317 |
Southeastern Resarch Group, Inc. | Tallahassee, Florida 32308 |
Peachtree Hematology-Oncology Consultants | Atlanta, Georgia 30309 |
St. Alphonsus Regional Medical Center | Boise, Idaho 83706 |
Idaho Urologic Institute, PA | Meridian, Idaho 83642 |
OSF St Mary Medical Center | Galesburg, Illinois 61401 |
Midwest Urology/RMD Clinical Research Institute | Melrose Park, Illinois 60160 |
Community Care Physicians, PC / The Urological Institute of Northeastern New York | Albany, New York 12208 |
University Urological Associates | New York, New York 10016 |
Urologic Consultants of SE PA | Bala Cynwyd, Pennsylvania 19004 |
Center for Urologic Care of the Main Line | Bryn Mawr, Pennsylvania 19010 |
University of Pittsburgh Physicians, Department of Urology | Pittsburgh, Pennsylvania 15232 |
Roger D. Fincher, M.D., P.S. | Spokane, Washington 99204 |