Trial record 1 of 1 for:    NCT01605227
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Study of Cabozantinib (XL184) Versus Prednisone in Men With Metastatic Castration-resistant Prostate Cancer Previously Treated With Docetaxel and Abiraterone or MDV3100 (COMET-1)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Exelixis
ClinicalTrials.gov Identifier:
NCT01605227
First received: May 22, 2012
Last updated: September 26, 2013
Last verified: September 2013
  Purpose

This study will evaluate the effect of cabozantinib compared to prednisone on overall survival in men with previously treated metastatic castration-resistant prostate cancer with bone-dominant disease who have experienced disease progression on docetaxel-containing chemotherapy and abiraterone or MDV3100.


Condition Intervention Phase
Prostate Cancer
Castration Resistant Prostate Cancer
Pain
Prostatic Neoplasms
Drug: cabozantinib
Drug: prednisone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-blind, Controlled Study of Cabozantinib (XL184) Versus Prednisone in Metastatic Castration-resistant Prostate Cancer Patients Who Have Received Prior Docetaxel and Prior Abiraterone or MDV3100

Resource links provided by NLM:


Further study details as provided by Exelixis:

Primary Outcome Measures:
  • Overall survival [ Time Frame: Through 21 months after study start ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bone scan response [ Time Frame: End of Week 12 ] [ Designated as safety issue: No ]
    Bone scans will be evaluated by an independent radiology facility for response


Estimated Enrollment: 960
Study Start Date: June 2012
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cabozantinib
Subjects randomized to the cabozantinib arm will also receive placebo-matched prednisone capsules.
Drug: cabozantinib
Tablets taken orally once-daily
Other Name: XL184
Active Comparator: prednisone
Subjects randomized to the prednisone arm will also receive placebo-matched cabozantinib.
Drug: prednisone
Taken twice a day orally. Commercially-obtained prednisone tablets will be over-encapsulated in order to blind identity.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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 3 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.
  • Liver or brain metastases or cranial epidural disease.
  • Requires concomitant treatment, in therapeutic doses, with anticoagulants antiplatelet agents.
  • 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 in the last 5 years.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01605227

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Locations
United States, Alabama
Birmingham, Alabama, United States, 35205
United States, Alaska
Anchorage, Alaska, United States, 99508
United States, Arizona
Phoenix, Arizona, United States, 85016
Scottsdale, Arizona, United States, 85255
Tuscon, Arizona, United States, 85710
United States, Arkansas
Jonesboro, Arkansas, United States, 72401
United States, California
Duarte, California, United States, 91010
Highland, California, United States, 92346
La Jolla, California, United States, 92093
Los Angeles, California, United States, 90033
Montebello, California, United States, 90640
Orange, California, United States, 92868
Palo Alto, California, United States, 94301
Rancho Mirage, California, United States, 92270
Saint Helena, California, United States, 94574
San Marcos, California, United States, 92069
Vallejo, California, United States, 94589
United States, Colorado
Aurora, Colorado, United States, 80045
United States, Connecticut
New Haven, Connecticut, United States, 06520
Southington, Connecticut, United States, 06489
United States, Florida
Miami Beach, Florida, United States, 33140
Ocala, Florida, United States, 34471
Orlando, Florida, United States, 32806
Tampa, Florida, United States, 33612
Titusville, Florida, United States, 32796
Wellington, Florida, United States, 33449
West Palm Beach, Florida, United States, 33401
United States, Georgia
Athens, Georgia, United States, 30607
Atlanta, Georgia, United States, 30318
Marietta, Georgia, United States, 30060
United States, Illinois
Galesburg, Illinois, United States, 61401
Niles, Illinois, United States, 60714
United States, Iowa
Ames, Iowa, United States, 50010
Sioux City, Iowa, United States, 51101
United States, Kansas
Wichita, Kansas, United States, 67214
United States, Kentucky
Hazard, Kentucky, United States, 41701
Louisville, Kentucky, United States, 40202
United States, Maine
Brewer, Maine, United States, 04412
United States, Maryland
Baltimore, Maryland, United States, 21201
Bethesda, Maryland, United States, 20817
Towson, Maryland, United States, 21204
United States, Massachusetts
Boston, Massachusetts, United States, 02114
Boston, Massachusetts, United States, 02118
Methuen, Massachusetts, United States, 01844
United States, Michigan
Detroit, Michigan, United States, 48202
Wyoming, Michigan, United States, 49509
United States, Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Jefferson City, Missouri, United States, 65109
Springfield, Missouri, United States, 65804
United States, Nebraska
Lincoln, Nebraska, United States, 68506
Omaha, Nebraska, United States, 68130
United States, New Jersey
Hackensack, New Jersey, United States, 07601
Lawrenceville, New Jersey, United States, 08648
United States, New York
Albany, New York, United States, 12208
Garden City, New York, United States, 11530
New York, New York, United States, 10065
United States, North Carolina
Pinehurst, North Carolina, United States, 28374
United States, North Dakota
Bismark, North Dakota, United States, 58501
United States, Ohio
Cincinnati, Ohio, United States, 45219
Columbus, Ohio, United States, 43221
United States, Oregon
Portland, Oregon, United States, 97227
United States, Pennsylvania
Bryn Mawr, Pennsylvania, United States, 19010
Hershey, Pennsylvania, United States, 17033
Lancaster, Pennsylvania, United States, 17604
United States, South Carolina
Greenville, South Carolina, United States, 29615
United States, Tennessee
Chattanooga, Tennessee, United States, 37421
United States, Texas
Amarillo, Texas, United States, 79106
Bedford, Texas, United States, 76022
Houston, Texas, United States, 77024
Laredo, Texas, United States, 78041
San Antonio, Texas, United States, 78217
United States, Utah
Salt Lake City, Utah, United States, 84112
United States, Vermont
Burlington, Vermont, United States, 05405
United States, Virginia
Fairfax, Virginia, United States, 22031
Newport News, Virginia, United States, 23601
United States, Washington
Spokane, Washington, United States, 99204
United States, Wisconsin
Green Bay, Wisconsin, United States, 54311
Australia, New South Wales
Albury, New South Wales, Australia, 2640
Concord, New South Wales, Australia, 2193
Darlinghurst, New South Wales, Australia, 2010
Kogarah, New South Wales, Australia, 2217
Port Macquarie, New South Wales, Australia, 2444
Randwick, New South Wales, Australia, 2031
Wahroonga, New South Wales, Australia, 2076
Westmead, New South Wales, Australia, 2145
Australia, Queensland
South Brisbane, Queensland, Australia, 4101
Southport, Queensland, Australia, 4215
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Adelaide, South Australia, Australia, 5000
Kurralta Park, South Australia, Australia, 5037
Australia, Tasmania
Hobart, Tasmania, Australia, 7000
Australia, Victoria
Box Hill, Victoria, Australia, 3128
East Bentleigh, Victoria, Australia, 3165
Wodonga, Victoria, Australia, 3690
Australia, Western Australia
Perth, Western Australia, Australia, 6000
Austria
Linz, Austria, 4010
Salzburg, Austria, 5020
Wein, Austria, 1100
Wien, Austria, 1090
Belgium
Aalst, Belgium, 9300
Bonheiden, Belgium, 2820
Brussels, Belgium, 1090
Brussels, Belgium, 1200
Brussels, Belgium, 1000
Gent, Belgium, 9000
Hasselt, Belgium, 3500
Leuven, Belgium, B-3000
Liège, Belgium, 4000
Roeselare, Belgium, 8800
Canada, Alberta
Calgary, Alberta, Canada, T2N 4N2
Canada, British Columbia
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, New Brunswick
Miramichi, New Brunswick, Canada, E1V 1Y3
Canada, Nova Scotia
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
London, Ontario, Canada, N6A 4L6
Owen Sound, Ontario, Canada, N4K 2J1
Canada, Quebec
Montreal, Quebec, Canada, H2L4M1
Canada
Quebec, Canada, G1R 2J6
France
Angers, France, 49933
Besançon, France, 25030
Bordeaux, France, 33076
Caen, France, 14076
Clermont Ferrand, France, 63011
Dijon, France, 21079
La Roche sur Yon, France, 85925
Le Mans, France, 72000
Lille, France, 59000
Lyon Cedex 08, France, 69373
Marseille, France, 13273
Nancy, France, 54100
Paris, France, 75230
Paris, France, 75014
Paris, France, 75010
Paris, France, 75015
Paris, France, 75005
Pierre Benite, France, 69495
Rennes, France, 35042
Saint Herblain, France, 44805
Strasbourg, France, 67000
Suresnes, France, 92151
Villejuif Cedex, France, 94805
Germany
Aachen, Germany, 52074
Aachen, Germany, 52062
Berlin, Germany, 13055
Berlin, Germany, 12200
Braunschweig, Germany, 38126
Dresden, Germany, 01307
Dusseldorf, Germany, 40225
Frankfurt am Main, Germany, 60488
Freiburg, Germany, 79106
Furth, Germany, 90766
Gütersloh, Germany, 33332
Hamburg, Germany, 22763
Hamburg, Germany, 20246
Hamburg, Germany, 22399
Hannover, Germany, 30625
Heidelberg, Germany, 69120
Homburg, Germany, 66421
Kassel, Germany, 34125
Kempen, Germany, 47906
Kirchheim, Germany, 73230
Koln, Germany, 50968
Mannheim, Germany, 68167
Munchen, Germany, 81675
Munster, Germany, 48149
Nurtingen, Germany, 72622
Offenburg, Germany, 77654
Traunstein, Germany, 83278
Tubingen, Germany, 72076
Weiden, Germany, 92637
Wuppertal, Germany, 42103
Ireland
Cork, Ireland
Dublin, Ireland, 24
Dublin, Ireland, 7
Galway, Ireland
Italy
Ancona, Italy, 60126
Arezzo, Italy, 52100
Aviano, Italy, 33081
Brindisi, Italy, 72100
Cremona, Italy, 26100
Genova, Italy, 16132
Livorno, Italy, 57123
Meldola, Italy, 47014
Milano, Italy, 20132
Milano, Italy, 20133
Milano, Italy, 20162
Modena, Italy, 41124
Napoli, Italy, 80131
Novara, Italy, 28100
Orbassano, Italy, 10043
Padova, Italy, 35128
Pavia, Italy, 27100
Pisa, Italy, 56126
Pordenone, Italy, 33170
Ravenna, Italy, 48121
Rimini, Italy, 47900
Roma, Italy, 00128
Roma, Italy, 00152
Rozzano, Italy, 20089
Terni, Italy, 05100
Torino, Italy, 10126
Verona, Italy, 37134
Netherlands
Amsterdam, Netherlands, 1066 CX
Groningen, Netherlands, 9713 GZ
Groningen, Netherlands, 9728 NT
Hoofddorp, Netherlands, 2134 TM
Nieuwegein, Netherlands, 3435 CM
Nijmegen, Netherlands, 6525 GA
Rotterdam, Netherlands, 3075 EA
Rotterdam, Netherlands, 3045 PM
Tilburg, Netherlands, 5042 AD
Zwolle, Netherlands, 8025 AB
Puerto Rico
Ponce, Puerto Rico, 00716
Spain
Málaga, Andalucía, Spain, 29010
Sevilla, Andalucía, Spain, 41013
Oviedo, Asturias, Spain, 33006
Palma de Mallorca, Baleares, Spain, 07010
La Laguna, Canarias, Spain, 38320
Badalona, Cataluña, Spain, 08916
Barcelona, Cataluña, Spain, 08036
Barcelona, Cataluña, Spain, 08003
Barcelona, Cataluña, Spain, 08035
Barcelona, Cataluña, Spain, 08023
Barcelona, Cataluña, Spain, 08025
L'Hospitalet de Llobregat, Cataluña, Spain, 08908
Manresa, Cataluña, Spain, 08243
Elche, Comunidad Valenciana, Spain, 03016
Valencia, Comunidad Valenciana, Spain, 46009
A Coruña, Galicia, Spain, 15006
Santiago de Compostela, Galicia, Spain, 15706
Madrid, Madrid, Communidad de, Spain, 28922
Madrid, Madrid, Communidad de, Spain, 28041
Madrid, Madrid, Communidad de, Spain, 28007
Madrid, Madrid, Communidad de, Spain, 28050
Madrid, Madrid, Communidad de, Spain, 28040
Majadahonda, Madrid, Communidad de, Spain, 28222
Pamplona, Navarra, Spain, 31008
Sweden
Gotenborg, Sweden, SE 41345
Malmo, Sweden, SE-20502
Orebro, Sweden, SE-70185
Stockholm, Sweden, SE-17176
Umea, Sweden, SE-90184
Uppsala, Sweden, SE 75185
Vaxjo, Sweden, SE-35185
United Kingdom
Aberdeen, United Kingdom, AB25 2ZN
Bath, United Kingdom, BA1 3NG
Birmingham, United Kingdom, B15 2TH
Brighton, United Kingdom, BN2 5BE
Bristol, United Kingdom, BS2 8ED
Cambridge, United Kingdom, CB2 2QQ
Cardiff, United Kingdom, CF14 2TL
Cottingham, United Kingdom, HU16 5JQ
Edinburgh, United Kingdom, EH4 2XU
Inverness, United Kingdom, IV2 3UJ
Lancaster, United Kingdom, LA1 4RP
Leeds, United Kingdom, LS9 7TF
London, United Kingdom, SE1 9RT
London, United Kingdom, W12 0HS
Maidstone, United Kingdom, ME16 9QQ
Northwood, United Kingdom, HA6 2RN
Plymouth, United Kingdom, PL6 8DH
Sheffield, United Kingdom, S10 2SJ
Southampton, United Kingdom, S16 6YD
Sutton, United Kingdom, SM2 5PT
Wirral, United Kingdom, CH63 4JY
Sponsors and Collaborators
Exelixis
  More Information

No publications provided

Responsible Party: Exelixis
ClinicalTrials.gov Identifier: NCT01605227     History of Changes
Other Study ID Numbers: XL184-307, 2012-001834-33
Study First Received: May 22, 2012
Last Updated: September 26, 2013
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria : Federal Ministry for Labour, Health, and Social Affairs
Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Health Canada
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Germany: Federal Institute for Drugs and Medical Devices
Ireland: Irish Medicines Board
Italy: Ministry of Health
Netherlands: Medicines Evaluation Board (MEB)
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Exelixis:
prostate cancer
castration resistant prostate cancer
bone pain
CRPC

Additional relevant MeSH terms:
Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Prednisone
Docetaxel
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on July 29, 2014