Study of Cabozantinib (XL184) Versus Prednisone in Men With Metastatic Castration-resistant Prostate Cancer Previously Treated With Docetaxel and... | NCT01605227 | Trialant

Study of Cabozantinib (XL184) Versus Prednisone in Men With Metastatic Castration-resistant Prostate Cancer Previously Treated With Docetaxel and... | NCT01605227 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: Male
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

Histological or cytological diagnosis of castration resistant prostate cancer (serum testosterone less than 50 ng/dL).

Evidence of bone metastasis related to prostate cancer on bone scans.

Received prior docetaxel (minimum cumulative dose of 225 mg/m2) and either abiraterone or MDV3100 treatment and has evidence of prostate cancer progression on each agent independently.

Maintenance of LHRH agonist or antagonist unless treated with orchiectomy.

Recovered from toxicities related to any prior treatments, unless the toxicities are clinically non significant or easily manageable.

Adequate organ and marrow function.

Capable of understanding and complying with the protocol requirements and signed the informed consent form.

Sexually active fertile patients and their partners must agree to use medically accepted methods of contraception (eg, barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for 4 months after the last dose of study treatment.

Exclusion Criteria:

Prior treatment with cabozantinib.

Treatment with docetaxel, abiraterone, or MDV3100 in the last 2 weeks; or with any other type of cytotoxic or investigational anticancer agent in the last 2 weeks.

Radiation within 4 weeks (excluded if to mediastinum) or radionuclide treatment within 6 weeks of randomization.

Known brain metastases or cranial epidural disease.

Requires concomitant treatment, in therapeutic doses, with anticoagulants.

Requires chronic concomitant treatment of strong CYP3A4 inducers (eg, dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, and St. John's Wort).

Uncontrolled, significant intercurrent illness including, but not limited to, cardiovascular disorders, gastrointestinal disorders, active infections, non-healing wounds, recent surgery.

Clinically significant hematemesis or hemoptysis, or other signs indicative of pulmonary hemorrhage in the last 3 months, or history of other significant bleeding in the past 6 months.

Cavitating pulmonary lesion(s) or a lesion invading or encasing a major blood vessel.

QTcF > 500 ms within 7 days of randomization.

Unable to swallow capsules or tablets.

Previously-identified allergy or hypersensitivity to components of the study treatment formulations.

Another diagnosis of malignancy requiring systemic treatment within 2 years of randomization.

-

Birmingham, Alabama 35205, United States

-

Anchorage, Alaska 99508, United States

-

Phoenix, Arizona 85016, United States

-

Scottsdale, Arizona 85255, United States

-

Tucson, Arizona 85710, United States

-

Jonesboro, Arkansas 72401, United States

-

Duarte, California 91010, United States

-

Highland, California 92346, United States

-

La Jolla, California 92093, United States

-

Los Angeles, California 90033, United States

-

Montebello, California 90640, United States

-

Orange, California 92868, United States

-

Palo Alto, California 94301, United States

-

Rancho Mirage, California 92270, United States

-

San Marcos, California 92069, United States

-

St. Helena, California 94574, United States

-

Vallejo, California 94589, United States

-

Aurora, Colorado 80045, United States

-

New Haven, Connecticut 06520, United States

-

Southington, Connecticut 06489, United States

-

Miami Beach, Florida 33140, United States

-

Ocala, Florida 34471, United States

-

Orlando, Florida 32806, United States

-

Tampa, Florida 33612, United States

-

Titusville, Florida 32796, United States

-

Wellington, Florida 33449, United States

-

West Palm Beach, Florida 33401, United States

-

Athens, Georgia 30607, United States

-

Atlanta, Georgia 30318, United States

-

Marietta, Georgia 30060, United States

-

Galesburg, Illinois 61401, United States

-

Niles, Illinois 60714, United States

-

Ames, Iowa 50010, United States

-

Sioux City, Iowa 51101, United States

-

Wichita, Kansas 67214, United States

-

Hazard, Kentucky 41701, United States

-

Louisville, Kentucky 40202, United States

-

Brewer, Maine 04412, United States

-

Baltimore, Maryland 21201, United States

-

Bethesda, Maryland 20817, United States

-

Towson, Maryland 21204, United States

-

Boston, Massachusetts 02114, United States

-

Boston, Massachusetts 02118, United States

-

Methuen, Massachusetts 01844, United States

-

Detroit, Michigan 48202, United States

-

Wyoming, Michigan 49509, United States

-

Minneapolis, Minnesota 55455, United States

-

Jefferson City, Missouri 65109, United States

-

Springfield, Missouri 65804, United States

-

Lincoln, Nebraska 68506, United States

-

Omaha, Nebraska 68130, United States

-

Hackensack, New Jersey 07601, United States

-

Lawrenceville, New Jersey 08648, United States

-

Albany, New York 12208, United States

-

Garden City, New York 11530, United States

-

New York, New York 10065, United States

-

Pinehurst, North Carolina 28374, United States

-

Bismarck, North Dakota 58501, United States

-

Cincinnati, Ohio 45219, United States

-

Columbus, Ohio 43221, United States

-

Portland, Oregon 97227, United States

-

Bryn Mawr, Pennsylvania 19010, United States

-

Hershey, Pennsylvania 17033, United States

-

Lancaster, Pennsylvania 17604, United States

-

Greenville, South Carolina 29615, United States

-

Chattanooga, Tennessee 37421, United States

-

Amarillo, Texas 79106, United States

-

Bedford, Texas 76022, United States

-

Houston, Texas 77024, United States

-

Laredo, Texas 78041, United States

-

San Antonio, Texas 78217, United States

-

Salt Lake City, Utah 84112, United States

-

Burlington, Vermont 05405, United States

-

Fairfax, Virginia 22031, United States

-

Newport News, Virginia 23601, United States

-

Spokane, Washington 99204, United States

-

Green Bay, Wisconsin 54311, United States

-

Albury, New South Wales 2640, Australia

-

Concord, New South Wales 2193, Australia

-

Darlinghurst, New South Wales 2010, Australia

-

Kogarah, New South Wales 2217, Australia

-

Port Macquarie, New South Wales 2444, Australia

-

Randwick, New South Wales 2031, Australia

-

Wahroonga, New South Wales 2076, Australia

-

Westmead, New South Wales 2145, Australia

-

South Brisbane, Queensland 4101, Australia

-

Southport, Queensland 4215, Australia

-

Woolloongabba, Queensland 4102, Australia

-

Adelaide, South Australia 5000, Australia

-

Kurralta Park, South Australia 5037, Australia

-

Hobart, Tasmania 7000, Australia

-

Bentleigh East, Victoria 3165, Australia

-

Box Hill, Victoria 3128, Australia

-

Wodonga, Victoria 3690, Australia

-

Perth, Western Australia 6000, Australia

-

Linz, 4010, Austria

-

Salzburg, 5020, Austria

-

Vienna, 1090, Austria

-

Wein, 1100, Austria

-

Aalst, 9300, Belgium

-

Bonheiden, 2820, Belgium

-

Brussels, 1000, Belgium

-

Brussels, 1090, Belgium

-

Brussels, 1200, Belgium

-

Ghent, 9000, Belgium

-

Hasselt, 3500, Belgium

-

Leuven, B-3000, Belgium

-

Liège, 4000, Belgium

-

Roeselare, 8800, Belgium

-

Calgary, Alberta T2N 4N2, Canada

-

Vancouver, British Columbia V5Z 4E6, Canada

-

Miramichi, New Brunswick E1V 1Y3, Canada

-

Halifax, Nova Scotia B3H 1V7, Canada

-

London, Ontario N6A 4L6, Canada

-

Owen Sound, Ontario N4K 2J1, Canada

-

Montreal, Quebec H2L4M1, Canada

-

Québec, G1R 2J6, Canada

-

Angers, 49933, France

-

Besançon, 25030, France

-

Bordeaux, 33076, France

-

Caen, 14076, France

-

Clermont-Ferrand, 63011, France

-

Dijon, 21079, France

-

La Roche-sur-Yon, 85925, France

-

Le Mans, 72000, France

-

Lille, 59000, France

-

Lyon, 69373, France

-

Marseille, 13273, France

-

Nancy, 54100, France

-

Paris, 75005, France

-

Paris, 75010, France

-

Paris, 75014, France

-

Paris, 75015, France

-

Paris, 75230, France

-

Pierre-Bénite, 69495, France

-

Rennes, 35042, France

-

Saint-Herblain, 44805, France

-

Strasbourg, 67000, France

-

Suresnes, 92151, France

-

Villejuif, 94805, France

-

Aachen, 52062, Germany

-

Aachen, 52074, Germany

-

Berlin, 12200, Germany

-

Berlin, 13055, Germany

-

Braunschweig, 38126, Germany

-

Cologne, 50968, Germany

-

Dresden, 01307, Germany

-

Düsseldorf, 40225, Germany

-

Frankfurt am Main, 60488, Germany

-

Freiburg im Breisgau, 79106, Germany

-

Fürth, 90766, Germany

-

Gütersloh, 33332, Germany

-

Hamburg, 20246, Germany

-

Hamburg, 22399, Germany

-

Hamburg, 22763, Germany

-

Hanover, 30625, Germany

-

Heidelberg, 69120, Germany

-

Homburg, 66421, Germany

-

Kassel, 34125, Germany

-

Kempen, 47906, Germany

-

Kirchheim, 73230, Germany

-

Mannheim, 68167, Germany

-

München, 81675, Germany

-

Münster, 48149, Germany

-

Nürtingen, 72622, Germany

-

Offenburg, 77654, Germany

-

Traunstein, 83278, Germany

-

Tübingen, 72076, Germany

-

Weiden, 92637, Germany

-

Wuppertal, 42103, Germany

-

Cork, Ireland

-

Dublin, 24, Ireland

-

Dublin, 7, Ireland

-

Galway, Ireland

-

Ancona, 60126, Italy

-

Arezzo, 52100, Italy

-

Aviano, 33081, Italy

-

Brindisi, 72100, Italy

-

Cremona, 26100, Italy

-

Genova, 16132, Italy

-

Livorno, 57123, Italy

-

Meldola, 47014, Italy

-

Milan, 20132, Italy

-

Milan, 20133, Italy

-

Milan, 20162, Italy

-

Modena, 41124, Italy

-

Naples, 80131, Italy

-

Novara, 28100, Italy

-

Orbassano, 10043, Italy

-

Padova, 35128, Italy

-

Pavia, 27100, Italy

-

Pisa, 56126, Italy

-

Pordenone, 33170, Italy

-

Ravenna, 48121, Italy

-

Rimini, 47900, Italy

-

Roma, 00128, Italy

-

Roma, 00152, Italy

-

Rozzano, 20089, Italy

-

Terni, 05100, Italy

-

Torino, 10126, Italy

-

Verona, 37134, Italy

-

Amsterdam, 1066 CX, Netherlands

-

Groningen, 9713 GZ, Netherlands

-

Groningen, 9728 NT, Netherlands

-

Hoofddorp, 2134 TM, Netherlands

-

Nieuwegein, 3435 CM, Netherlands

-

Nijmegen, 6525 GA, Netherlands

-

Rotterdam, 3045 PM, Netherlands

-

Rotterdam, 3075 EA, Netherlands

-

Tilburg, 5042 AD, Netherlands

-

Zwolle, 8025 AB, Netherlands

-

Ponce, 00716, Puerto Rico

-

Málaga, Andalusia 29010, Spain

-

Seville, Andalusia 41013, Spain

-

Palma de Mallorca, Balearic Islands 07010, Spain

-

San Cristóbal de La Laguna, Canary Islands 38320, Spain

-

Badalona, Catalonia 08916, Spain

-

Barcelona, Catalonia 08003, Spain

-

Barcelona, Catalonia 08023, Spain

-

Barcelona, Catalonia 08025, Spain

-

Barcelona, Catalonia 08035, Spain

-

Barcelona, Catalonia 08036, Spain

-

L'Hospitalet de Llobregat, Catalonia 08908, Spain

-

Manresa, Catalonia 08243, Spain

-

A Coruña, Galicia 15006, Spain

-

Santiago de Compostela, Galicia 15706, Spain

-

Madrid, Madrid, Communidad de 28007, Spain

-

Madrid, Madrid, Communidad de 28040, Spain

-

Madrid, Madrid, Communidad de 28041, Spain

-

Madrid, Madrid, Communidad de 28050, Spain

-

Madrid, Madrid, Communidad de 28922, Spain

-

Majadahonda, Madrid, Communidad de 28222, Spain

-

Pamplona, Navarre 31008, Spain

-

Oviedo, Principality of Asturias 33006, Spain

-

Elche, Valencia 03016, Spain

-

Valencia, Valencia 46009, Spain

-

Gotenborg, SE 41345, Sweden

-

Malmö, SE-20502, Sweden

-

Örebro, SE-70185, Sweden

-

Stockholm, SE-17176, Sweden

-

Umeå, SE-90184, Sweden

-

Uppsala, SE 75185, Sweden

-

Vaxjo, SE-35185, Sweden

-

Aberdeen, AB25 2ZN, United Kingdom

-

Bath, BA1 3NG, United Kingdom

-

Birmingham, B15 2TH, United Kingdom

-

Brighton, BN2 5BE, United Kingdom

-

Bristol, BS2 8ED, United Kingdom

-

Cambridge, CB2 2QQ, United Kingdom

-

Cardiff, CF14 2TL, United Kingdom

-

Cottingham, HU16 5JQ, United Kingdom

-

Edinburgh, EH4 2XU, United Kingdom

-

Inverness, IV2 3UJ, United Kingdom

-

Lancaster, LA1 4RP, United Kingdom

-

Leeds, LS9 7TF, United Kingdom

-

London, SE1 9RT, United Kingdom

-

London, W12 0HS, United Kingdom

-

Maidstone, ME16 9QQ, United Kingdom

-

Metropolitan Borough of Wirral, CH63 4JY, United Kingdom

-

Northwood, HA6 2RN, United Kingdom

-

Plymouth, PL6 8DH, United Kingdom

-

Sheffield, S10 2SJ, United Kingdom

-

Southampton, S16 6YD, United Kingdom

-

Sutton, SM2 5PT, United Kingdom