Study of Cabozantinib (XL184) Versus Prednisone in Men With Metastatic Castration-resistant Prostate Cancer Previously Treated With Docetaxel and Abiraterone or MDV3100
NCT ID: NCT01605227
Last Updated: 2018-03-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1028 participants
INTERVENTIONAL
2012-07-31
2015-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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cabozantinib
Subjects randomized to the cabozantinib arm will also receive placebo-matched prednisone capsules.
cabozantinib
Tablets taken orally once-daily
prednisone
Subjects randomized to the prednisone arm will also receive placebo-matched cabozantinib.
prednisone
Taken twice a day orally. Commercially-obtained prednisone tablets will be over-encapsulated in order to blind identity.
Interventions
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cabozantinib
Tablets taken orally once-daily
prednisone
Taken twice a day orally. Commercially-obtained prednisone tablets will be over-encapsulated in order to blind identity.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
MALE
No
Sponsors
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Exelixis
INDUSTRY
Responsible Party
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Locations
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Birmingham, Alabama, United States
Anchorage, Alaska, United States
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Tucson, Arizona, United States
Jonesboro, Arkansas, United States
Duarte, California, United States
Highland, California, United States
La Jolla, California, United States
Los Angeles, California, United States
Montebello, California, United States
Orange, California, United States
Palo Alto, California, United States
Rancho Mirage, California, United States
San Marcos, California, United States
St. Helena, California, United States
Vallejo, California, United States
Aurora, Colorado, United States
New Haven, Connecticut, United States
Southington, Connecticut, United States
Miami Beach, Florida, United States
Ocala, Florida, United States
Orlando, Florida, United States
Tampa, Florida, United States
Titusville, Florida, United States
Wellington, Florida, United States
West Palm Beach, Florida, United States
Athens, Georgia, United States
Atlanta, Georgia, United States
Marietta, Georgia, United States
Galesburg, Illinois, United States
Niles, Illinois, United States
Ames, Iowa, United States
Sioux City, Iowa, United States
Wichita, Kansas, United States
Hazard, Kentucky, United States
Louisville, Kentucky, United States
Brewer, Maine, United States
Baltimore, Maryland, United States
Bethesda, Maryland, United States
Towson, Maryland, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Methuen, Massachusetts, United States
Detroit, Michigan, United States
Wyoming, Michigan, United States
Minneapolis, Minnesota, United States
Jefferson City, Missouri, United States
Springfield, Missouri, United States
Lincoln, Nebraska, United States
Omaha, Nebraska, United States
Hackensack, New Jersey, United States
Lawrenceville, New Jersey, United States
Albany, New York, United States
Garden City, New York, United States
New York, New York, United States
Pinehurst, North Carolina, United States
Bismarck, North Dakota, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Portland, Oregon, United States
Bryn Mawr, Pennsylvania, United States
Hershey, Pennsylvania, United States
Lancaster, Pennsylvania, United States
Greenville, South Carolina, United States
Chattanooga, Tennessee, United States
Amarillo, Texas, United States
Bedford, Texas, United States
Houston, Texas, United States
Laredo, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Burlington, Vermont, United States
Fairfax, Virginia, United States
Newport News, Virginia, United States
Spokane, Washington, United States
Green Bay, Wisconsin, United States
Albury, New South Wales, Australia
Concord, New South Wales, Australia
Darlinghurst, New South Wales, Australia
Kogarah, New South Wales, Australia
Port Macquarie, New South Wales, Australia
Randwick, New South Wales, Australia
Wahroonga, New South Wales, Australia
Westmead, New South Wales, Australia
South Brisbane, Queensland, Australia
Southport, Queensland, Australia
Woolloongabba, Queensland, Australia
Adelaide, South Australia, Australia
Kurralta Park, South Australia, Australia
Hobart, Tasmania, Australia
Bentleigh East, Victoria, Australia
Box Hill, Victoria, Australia
Wodonga, Victoria, Australia
Perth, Western Australia, Australia
Linz, , Austria
Salzburg, , Austria
Vienna, , Austria
Wein, , Austria
Aalst, , Belgium
Bonheiden, , Belgium
Brussels, , Belgium
Brussels, , Belgium
Brussels, , Belgium
Ghent, , Belgium
Hasselt, , Belgium
Leuven, , Belgium
Liège, , Belgium
Roeselare, , Belgium
Calgary, Alberta, Canada
Vancouver, British Columbia, Canada
Miramichi, New Brunswick, Canada
Halifax, Nova Scotia, Canada
London, Ontario, Canada
Owen Sound, Ontario, Canada
Montreal, Quebec, Canada
Québec, , Canada
Angers, , France
Besançon, , France
Bordeaux, , France
Caen, , France
Clermont-Ferrand, , France
Dijon, , France
La Roche-sur-Yon, , France
Le Mans, , France
Lille, , France
Lyon, , France
Marseille, , France
Nancy, , France
Paris, , France
Paris, , France
Paris, , France
Paris, , France
Paris, , France
Pierre-Bénite, , France
Rennes, , France
Saint-Herblain, , France
Strasbourg, , France
Suresnes, , France
Villejuif, , France
Aachen, , Germany
Aachen, , Germany
Berlin, , Germany
Berlin, , Germany
Braunschweig, , Germany
Cologne, , Germany
Dresden, , Germany
Düsseldorf, , Germany
Frankfurt am Main, , Germany
Freiburg im Breisgau, , Germany
Fürth, , Germany
Gütersloh, , Germany
Hamburg, , Germany
Hamburg, , Germany
Hamburg, , Germany
Hanover, , Germany
Heidelberg, , Germany
Homburg, , Germany
Kassel, , Germany
Kempen, , Germany
Kirchheim, , Germany
Mannheim, , Germany
München, , Germany
Münster, , Germany
Nürtingen, , Germany
Offenburg, , Germany
Traunstein, , Germany
Tübingen, , Germany
Weiden, , Germany
Wuppertal, , Germany
Cork, , Ireland
Dublin, , Ireland
Dublin, , Ireland
Galway, , Ireland
Ancona, , Italy
Arezzo, , Italy
Aviano, , Italy
Brindisi, , Italy
Cremona, , Italy
Genova, , Italy
Livorno, , Italy
Meldola, , Italy
Milan, , Italy
Milan, , Italy
Milan, , Italy
Modena, , Italy
Napoli, , Italy
Novara, , Italy
Orbassano, , Italy
Padua, , Italy
Pavia, , Italy
Pisa, , Italy
Pordenone, , Italy
Ravenna, , Italy
Rimini, , Italy
Roma, , Italy
Roma, , Italy
Rozzano, , Italy
Terni, , Italy
Torino, , Italy
Verona, , Italy
Amsterdam, , Netherlands
Groningen, , Netherlands
Groningen, , Netherlands
Hoofddorp, , Netherlands
Nieuwegein, , Netherlands
Nijmegen, , Netherlands
Rotterdam, , Netherlands
Rotterdam, , Netherlands
Tilburg, , Netherlands
Zwolle, , Netherlands
Ponce, , Puerto Rico
Málaga, Andalusia, Spain
Seville, Andalusia, Spain
Palma de Mallorca, Balearic Islands, Spain
San Cristóbal de La Laguna, Canary Islands, Spain
Badalona, Catalonia, Spain
Barcelona, Catalonia, Spain
Barcelona, Catalonia, Spain
Barcelona, Catalonia, Spain
Barcelona, Catalonia, Spain
Barcelona, Catalonia, Spain
L'Hospitalet de Llobregat, Catalonia, Spain
Manresa, Catalonia, Spain
A Coruña, Galicia, Spain
Santiago de Compostela, Galicia, Spain
Madrid, Madrid, Communidad de, Spain
Madrid, Madrid, Communidad de, Spain
Madrid, Madrid, Communidad de, Spain
Madrid, Madrid, Communidad de, Spain
Madrid, Madrid, Communidad de, Spain
Majadahonda, Madrid, Communidad de, Spain
Pamplona, Navarre, Spain
Oviedo, Principality of Asturias, Spain
Elche, Valencia, Spain
Valencia, Valencia, Spain
Gotenborg, , Sweden
Malmo, , Sweden
Örebro, , Sweden
Stockholm, , Sweden
Umeå, , Sweden
Uppsala, , Sweden
Vaxjo, , Sweden
Aberdeen, , United Kingdom
Bath, , United Kingdom
Birmingham, , United Kingdom
Brighton, , United Kingdom
Bristol, , United Kingdom
Cambridge, , United Kingdom
Cardiff, , United Kingdom
Cottingham, , United Kingdom
Edinburgh, , United Kingdom
Inverness, , United Kingdom
Lancaster, , United Kingdom
Leeds, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Maidstone, , United Kingdom
Metropolitan Borough of Wirral, , United Kingdom
Northwood, , United Kingdom
Plymouth, , United Kingdom
Sheffield, , United Kingdom
Southampton, , United Kingdom
Sutton, , United Kingdom
Countries
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References
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Heller G, McCormack R, Kheoh T, Molina A, Smith MR, Dreicer R, Saad F, de Wit R, Aftab DT, Hirmand M, Limon A, Fizazi K, Fleisher M, de Bono JS, Scher HI. Circulating Tumor Cell Number as a Response Measure of Prolonged Survival for Metastatic Castration-Resistant Prostate Cancer: A Comparison With Prostate-Specific Antigen Across Five Randomized Phase III Clinical Trials. J Clin Oncol. 2018 Feb 20;36(6):572-580. doi: 10.1200/JCO.2017.75.2998. Epub 2017 Dec 22.
Smith M, De Bono J, Sternberg C, Le Moulec S, Oudard S, De Giorgi U, Krainer M, Bergman A, Hoelzer W, De Wit R, Bogemann M, Saad F, Cruciani G, Thiery-Vuillemin A, Feyerabend S, Miller K, Houede N, Hussain S, Lam E, Polikoff J, Stenzl A, Mainwaring P, Ramies D, Hessel C, Weitzman A, Fizazi K. Phase III Study of Cabozantinib in Previously Treated Metastatic Castration-Resistant Prostate Cancer: COMET-1. J Clin Oncol. 2016 Sep 1;34(25):3005-13. doi: 10.1200/JCO.2015.65.5597. Epub 2016 Jul 11.
Other Identifiers
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2012-001834-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
XL184-307
Identifier Type: -
Identifier Source: org_study_id
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