|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsor: | Cougar Biotechnology, Inc. |
|---|---|
| Information provided by: | Cougar Biotechnology, Inc. |
| ClinicalTrials.gov Identifier: | NCT00638690 |
Purpose
This is a phase 3 study to compare the clinical benefit of abiraterone acetate plus prednisone with placebo plus prednisone in patients with metastatic castration-resistant prostate cancer (CRPC) who have failed one or two chemotherapy regimens. At least one of the previous chemotherapies must have contained docetaxel
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Castration-Resistant Prostate Cancer |
Drug: placebo plus prednisone/prednisolone Drug: abiraterone acetate plus prednisone/prednisolone |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Docetaxel-Based Chemotherapy |
| Estimated Enrollment: | 1158 |
| Study Start Date: | April 2008 |
| Estimated Study Completion Date: | June 2011 |
| Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
abiraterone acetate plus prednisone/prednisolone
|
Drug: abiraterone acetate plus prednisone/prednisolone
1000mg Daily/5mg Twice Daily
|
|
2: Placebo Comparator
placebo plus prednisone/prednisolone
|
Drug: placebo plus prednisone/prednisolone
1000mg Daily/5mg Twice Daily
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Major Inclusion Criteria:
Major Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Birmingham Hematology and Oncology Associates, LLC, Bruno Cancer Center | |
| Birmingham, Alabama, United States, 35205 | |
| United States, Arizona | |
| Arizona Clinical Research Center, Inc. | |
| Tuscon, Arizona, United States, 85715 | |
| United States, California | |
| Prostate Oncology Specialists, Inc. | |
| Marina Del Rey, California, United States, 90292 | |
| The Angeles Clinic and Research Institute | |
| Los Angeles, California, United States, 90025 | |
| University of California, Los Angeles School of Medicine | |
| Los Angeles, California, United States, 90095 | |
| Pacific Hemotology/Oncology | |
| San Francisco, California, United States, 94115 | |
| Sharp Clinical Oncology Research | |
| San Diego, California, United States, 92123 | |
| UCSF Helen Diller Family Comprehensive Cancer Center | |
| San Francisco, California, United States, 94115 | |
| Tower Cancer Research Foundation | |
| Beverly Hills, California, United States, 90211 | |
| City of Hope | |
| Duarte, California, United States, 91010 | |
| UC Davis Cancer Center | |
| Salto, California, United States, 95817 | |
| United States, Colorado | |
| University of Colorado Cancer Center | |
| Aurora, Colorado, United States, 80045 | |
| United States, Connecticut | |
| The Hope Clinic | |
| Bristol, Connecticut, United States, 06010 | |
| Hematology Oncology, P.C. Carl and Dorothy Bennett Cancer Center | |
| Stamford, Connecticut, United States, 06902 | |
| Yale Medical Group | |
| New Haven, Connecticut, United States, 06520 | |
| United States, Florida | |
| Florida Cancer Specialists | |
| Fort Myers, Florida, United States, 33901 | |
| The Center for Hematology-Oncology | |
| Boca Raton, Florida, United States, 33486 | |
| Bienes Cancer Center | |
| Fort Lauderdale, Florida, United States, 33308 | |
| Palm Beach Cancer Institute | |
| West Palm Beach, Florida, United States, 33403 | |
| United States, Georgia | |
| Peachtree Hematology & Oncology | |
| Atlanta, Georgia, United States, 30309 | |
| Georgia Cancer Specialists | |
| Tucker, Georgia, United States, 30084 | |
| United States, Hawaii | |
| Kaiser Permanente Medical Group | |
| Honolulu, Hawaii, United States, 96819 | |
| United States, Illinois | |
| Medical and surgical specialists | |
| Galesburg, Illinois, United States, 61401 | |
| Rush University Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| United States, Indiana | |
| Indiana University Melvin and Bren Simon Cancer Center | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Kansas | |
| Cancer Center of Kansas, P.A. | |
| Wichita, Kansas, United States, 67214 | |
| University of Kansas Medical Center | |
| Westwood, Kansas, United States, 66205 | |
| United States, Louisiana | |
| Hematology and Oncology Specialists | |
| Metairie, Louisiana, United States, 70006 | |
| Tulane University School of Medicine (Medical Oncologist) | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Maryland | |
| The Sidney Kimmel Comprehensive Cancer at John Hopkins | |
| Baltimore, Maryland, United States, 21231 | |
| United States, Massachusetts | |
| Massachusetts General Hospital Cancer Center | |
| Boston, Massachusetts, United States, 02114 | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02215 | |
| Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Michigan | |
| Henry Ford Health System | |
| Detroit, Michigan, United States, 48202 | |
| United States, Minnesota | |
| Hubert Humphrey Cancer Center North Memorial Health Care | |
| Robbinsdale, Minnesota, United States, 55422 | |
| United States, Missouri | |
| Washington University St. Louis School Medicine Siteman Cancer Center | |
| St. Louis, Missouri, United States, 63110 | |
| United States, Montana | |
| Billings Clinic | |
| Billings, Montana, United States, 59101 | |
| United States, Nebraska | |
| Alegent Health Bergan Mercy Hospital | |
| Omaha, Nebraska, United States, 68124 | |
| United States, Nevada | |
| Nevada Cancer Institute | |
| Las Vegas, Nevada, United States, 89135 | |
| Comprehensive Cancer Center of Nevada | |
| Las Vegas, Nevada, United States, 89169 | |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10065 | |
| The Arthur Smith Institute for Urology | |
| New Hyde Park, New York, United States, 11040 | |
| North Shore Hematology Oncology Associates | |
| East Setauket, New York, United States, 11733 | |
| New York University Medical Center - Weill Cornell Medical College | |
| New York, New York, United States, 10065 | |
| SUNY Stony brook | |
| Stony Brook, New York, United States, 11794 | |
| NYU Clinical Cancer Center | |
| New York, New York, United States, 10016 | |
| United States, North Carolina | |
| Cancer Center of North Carolina | |
| Raleigh, North Carolina, United States, 27607 | |
| Wake Forest University Health Sciences | |
| Winston-Salem, North Carolina, United States, 27157 | |
| Duke University Hospital Medical Center | |
| Durham, North Carolina, United States, 27705 | |
| United States, Ohio | |
| Gabrail Cancer Center | |
| Canton, Ohio, United States, 44718 | |
| Oncology Hematology Care | |
| Cincinnati, Ohio, United States, 45242 | |
| United States, Oregon | |
| The Oregon Clinic | |
| Portland, Oregon, United States, 97213 | |
| United States, Pennsylvania | |
| Fox Chase Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19111 | |
| University of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| United States, South Carolina | |
| Carolina Urologic Research Center (Urologist) | |
| Myrtle Beach, South Carolina, United States, 29572 | |
| United States, Tennessee | |
| Sarah Cannon Research Institute, LLC | |
| Nashville, Tennessee, United States, 37203 | |
| Chattanooga Oncology Hematology Associates | |
| Chattanooga, Tennessee, United States, 37404 | |
| United States, Texas | |
| University of Texas MD Anderson | |
| Houston, Texas, United States, 77030 | |
| Texas Oncology - Sammons Cancer Center | |
| Dallas, Texas, United States, 75246 | |
| University of Texas Health Science Center | |
| San Antonio, Texas, United States, 78229 | |
| United States, Virginia | |
| Virginia Cancer Institute | |
| Richmond, Virginia, United States, 23230 | |
| Urology of Virginia | |
| Norfolk, Virginia, United States, 23502 | |
| United States, Washington | |
| University of Washington School of Medicine (Medical Oncologist) | |
| Seattle, Washington, United States, 98109 | |
| VA Puget Sound Health Care | |
| Seattle, Washington, United States, 98108 | |
| Australia | |
| Ashford Cancer Centre | |
| Ashford, Australia, 5035 | |
| Southern Medical Day Care Center | |
| Wollongong, Australia, 2500 | |
| Royal Adelaide | |
| Adelaide, Australia, 5000 | |
| Royal Melbourne Hospital | |
| Melbourne, Australia, 3050 AU | |
| Royal Hobart Hospital | |
| Hobart, Australia, 7000 | |
| Austin Hospital Studley Road | |
| Heidelburg, Australia, 3084 | |
| Sydney Haematology Oncology Clinic | |
| Hornsby, Australia, NSW 2077 | |
| Haematology and Oncology Clinics of Australasia | |
| South Brisbane, Australia, 4101 | |
| Royal Brisbane and Women's Hospital | |
| Herston, Australia, 4029 | |
| Border Medical Oncology | |
| Wodonga, Australia, 3690 | |
| Western Hospital, Footscray Victoria | |
| Footscray, Australia, 3011 | |
| The Mount Hospital | |
| Perth, Australia, 6000 | |
| Royal Prince Alfred Hospital | |
| Camperdown, Australia, 2050 | |
| Liverpool Hospital | |
| Liverpool, Australia, 2170 | |
| St John of God Hospital Subiaco | |
| Subiaco, Australia, 6008 | |
| Barwon Health, Geelong Hospital | |
| Victoria, Australia | |
| Australia, New South Wales | |
| St. George Private Hospital, Oncology Day Care Centre | |
| Kogarah, New South Wales, Australia, 2217 | |
| Austria | |
| Department of Urology Medical University of Vienna | |
| Vienna, Austria, A-1090 | |
| Universitätsklinik für Urologie und Andrologie, Allgemeines Krankenhaus Salzburg | |
| Salzburg, Austria, A-5020 AT | |
| Urologische Abteilung Krankenhaus der Barmherzigen Schwestern Linz | |
| Linz, Austria, 4020 | |
| Belgium | |
| UZ Gasthuisberg | |
| Leuven, Belgium, B-3000 | |
| UZ Gent | |
| Gent, Belgium, B-9000 | |
| Catholic University Hospital St. Luc | |
| Bruxelles, Belgium, 1200 | |
| Middelheim ziekenhuis | |
| Antwerp, Belgium, 2020 | |
| Virga Jesseziekenhuis | |
| Hasselt, Belgium, B-3500 | |
| Imelda zieknhuis | |
| Bonheiden, Belgium, 2820 | |
| H.Hart ziekenhuis | |
| Roeselare, Belgium, B-8800 | |
| CHU Sart-Tilman | |
| Liege, Belgium, 4000 | |
| Urologie AZ Groeninge | |
| Kortrijk, Belgium, B-8500 | |
| AZ Sint Lucas | |
| Gent, Belgium, 9000 | |
| Canada | |
| Tom Baker Cancer Centre | |
| Calgary, Canada, T2N 4N2 | |
| Cross Cancer Institute | |
| Alberta, Canada | |
| Canada, British Columbia | |
| British Columbia Cancer Agency - Vancouver Clinic | |
| Vancouver, British Columbia, Canada, V5Z 4E6 | |
| British Columbia Cancer Agency-Centre for the Southern Interior | |
| Kelowna, British Columbia, Canada, V1Y 5L3 | |
| British Columbia Cancer Agency - Vancouver Island Cancer Centre | |
| Victoria, British Columbia, Canada, V8R 6V5 | |
| Canada, Nova Scotia | |
| Nova Scotia, Centre for Clinical Research Cancer Care Program | |
| Halifax, Nova Scotia, Canada, B3H1V7 | |
| Canada, Ontario | |
| Sunnybrook Health Sciences Centre | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Juravinski Cancer Centre Hamilton Health Services | |
| Hamilton, Ontario, Canada, L8V 5C2 | |
| London Regional Cancer Program at London Health Sciences Centre | |
| London, Ontario, Canada, N6A 4L6 | |
| Canada, Quebec | |
| Centre Hospitalier de l'Université de Montréal, Hôpital Notre-Dame | |
| Montreal, Quebec, Canada, H2L 4M1 | |
| McGill Department of Oncology, Clinical Research Program | |
| Montreal, Quebec, Canada, H2W 1S6 | |
| Canada, Saskatchewan | |
| Allan Blair Cancer Center at Pasqua Hospital | |
| Regina, Saskatchewan, Canada, S4T7T1 | |
| France | |
| Institut Gustave-Roussy | |
| France, France, 94805 | |
| Centre Hosptialier de Cannes | |
| Cannes, France, 06401 | |
| Centre René Gauducheau | |
| Nantes-St Herblain, France, F-44805 | |
| Centre Alexis Vautrin | |
| Vandoeuvre Les Nancy Cedex, France, 54511 | |
| Centre Georges François Leclerc | |
| Dijon, France, 21079 | |
| Centre François Baclesse | |
| Caen cedex 5, France, 14076 | |
| Centre Léon Bérard | |
| Lyon 08, France, 69373 | |
| Centre Paul Papin | |
| Angers Cedex 9, France, 49933 | |
| Germany | |
| Universitätsklinikum des Saarlandes | |
| Homburg/Saar, Germany, 66421 | |
| Urologische Gemeinschaftspraxis | |
| Hamburg, Germany, 22355 | |
| Charite Campus Benjamin Franklin | |
| Berlin, Germany, 12203 | |
| Universitatsklinikum "Carl Gustav Carus" der Technischen | |
| Dresden, Germany, 01307 | |
| Universitatsklinikum Aachen Urologie | |
| Aachen, Germany, 52074 | |
| Hungary | |
| County Hospital of Pecs | |
| Pecs, Hungary, 7623 HU | |
| Cholnoky Ferenc County Hospital, Oncology Department | |
| Veszprém, Hungary, H-8200 | |
| Markusovszky Lajos Teaching Hospital, Szombathely, Oncoradiology Department | |
| Vas County, Hungary, 9270 | |
| Ireland | |
| AMNCH | |
| Dublin, Ireland, 24 | |
| Bon Secours Hospital | |
| Cork, Ireland, 00000 | |
| Oncology Trials Unit CUH/MUH/SIVUH | |
| Cork, Ireland, 0000 | |
| Mater Private Hospital | |
| Dublin, Ireland, 7 | |
| Beaumont Hospital | |
| Dublin, Ireland, 9 | |
| Italy | |
| Az. Ospedaliera San Camillo-Forlanini | |
| Roma, Italy, 00152 | |
| Hospital "Misericordia" USL | |
| Via Senese 161, Italy, 58100 | |
| Arcispedale Santa Maria Nuova | |
| Reggio Emilia, Italy, 42100 | |
| Policlinico de Modena | |
| Modena, Italy, 41100 | |
| Hospital San Raffaele | |
| Milan, Italy, 20132 | |
| Netherlands | |
| U.M.C. St. Radboud, Nijmegen | |
| Nijmegen, Netherlands, 6500 GA | |
| Spain | |
| Hospital del Mar | |
| Barcelona, Spain, 08003 | |
| Hospital Germans Trias i Pujol | |
| Badalona, Spain, 08916 | |
| Hospital Son Dureta | |
| Palma de Mallorca, Spain, 07014 | |
| Hospital Madrid Norte Sanchinarro | |
| Madrid, Spain, 28050 | |
| Hospital Clinic i Provincial | |
| Barcelona, Spain, 08036 | |
| Clínica Universitaria de Navarra | |
| Pamplona, Spain, 31008 | |
| Institut Català d'Oncologia | |
| Barcelona, Spain, 08907 | |
| United Kingdom | |
| Royal Marsden Hospital | |
| Sutton, United Kingdom | |
| Hammersmith Hospital | |
| London, United Kingdom, W12 0NN | |
| Beatson West of Scotland Cancer Centre | |
| Glasgow, United Kingdom, G12 0YN | |
| Freeman Hospital | |
| Newcastle upon Tyne, United Kingdom, NE7 7DN | |
| The Christie Hosptial | |
| Manchester, United Kingdom, M20 4BX | |
| Addenbrooke's Hospital | |
| Cambridge, United Kingdom, CB2 0QQ | |
| Velindre Hospital, Wales College of Medicine | |
| Cardiff, United Kingdom, CF14-2TL | |
| University College London Hospitals | |
| London, United Kingdom, NW1 2PG | |
| Mount Vernon Cancer Centre | |
| Northwood, United Kingdom, HA6 2RN | |
| Northern Ireland Cancer Centre, Belfast City Hosp. | |
| Lisburn Road, United Kingdom, BT9 7AB | |
| United Kingdom, Birmingham | |
| CR-UK Institute for Cancer Studies, University of Birmingham | |
| Edgbaston, Birmingham, United Kingdom, B15 2TT | |
| United Kingdom, Oxford | |
| Oxford Cancer Centre | |
| Old Road Headington, Oxford, United Kingdom, OX3 7LT | |
| Study Chair: | Howard I Scher, MD | Memorial Sloan-Kettering Cancer Center |
| Study Chair: | JS de Bono, MD FRCP PhD | ICR/Royal Marsden Hospital |
More Information
| Responsible Party: | Cougar Biotechnology, Inc. ( Christopher M. Haqq MD PhD ) |
| Study ID Numbers: | COU-AA-301 |
| Study First Received: | March 13, 2008 |
| Last Updated: | May 11, 2009 |
| ClinicalTrials.gov Identifier: | NCT00638690 History of Changes |
| Health Authority: | United States: Food and Drug Administration; European Union: European Medicines Agency; Australia: National Health and Medical Research Council; Canada: Health Canada |
|
Metastatic Castration Resistant Prostate Cancer CRPC Abiraterone Acetate CB7630 |
|
Prednisolone acetate Methylprednisolone acetate Anti-Inflammatory Agents Prednisone Prostatic Diseases Genital Neoplasms, Male Methylprednisolone Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Urogenital Neoplasms Neuroprotective Agents Hormones Neoplasms by Site |
Therapeutic Uses Methylprednisolone Hemisuccinate Antineoplastic Agents, Hormonal Gastrointestinal Agents Genital Diseases, Male Protective Agents Glucocorticoids Pharmacologic Actions Neoplasms Autonomic Agents Prednisolone Peripheral Nervous System Agents Central Nervous System Agents Prostatic Neoplasms |
