A Study of Galeterone Compared to Enzalutamide In Men Expressing Androgen Receptor Splice Variant-7 mRNA (AR-V7) Metastatic CRPC
NCT ID: NCT02438007
Last Updated: 2023-03-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
953 participants
INTERVENTIONAL
2015-06-30
2016-11-30
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
NONE
Study Groups
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Galeterone
Galeterone
2550 mg galeterone tablets once daily PO
Enzalutamide
Enzalutamide
160 mg enzalutamide capsules once daily PO
Interventions
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Galeterone
2550 mg galeterone tablets once daily PO
Enzalutamide
160 mg enzalutamide capsules once daily PO
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Detectable AR-V7 from circulating tumors (CTCs)
* ECOG performance status 0 or 1
Exclusion Criteria
* Prior treatment with chemotherapy for CRPC
18 Years
MALE
No
Sponsors
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LTN PHARMACEUTICALS, INC.
INDUSTRY
Responsible Party
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Locations
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Pinnacle Oncology Hematology
Scottsdale, Arizona, United States
University Of Arizona Cancer Center
Tucson, Arizona, United States
City of Hope
Duarte, California, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
UCLA Jonsson Comprehensive Cancer Center
Los Angeles, California, United States
Prostate Oncology Specialists, Inc.
Marina del Rey, California, United States
UC Davis Cancer Center
Sacramento, California, United States
San Bernardino Urological Associates
San Bernardino, California, United States
Urology Speciality Group
Torrance, California, United States
University of Colorado Cancer Center Anschultz Cancer Pavilion
Aurora, Colorado, United States
The Urology Center of Colorado
Denver, Colorado, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
Boca Raton Community Hospital, Inc.
Boca Raton, Florida, United States
University of Florida Health Cancer Center
Orlando, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
First Urology
Jeffersonville, Indiana, United States
Tulane Medical Center
New Orleans, Louisiana, United States
Regional Urology, LLC
Shreveport, Louisiana, United States
University of Maryland Greenenbaum Cancer Center
Baltimore, Maryland, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Karmanos Cancer Center
Detroit, Michigan, United States
Urology Cancer Center and GU Research Network
Omaha, Nebraska, United States
Coastal Urology Associates
Brick, New Jersey, United States
Brooklyn Urology Research Group
Brooklyn, New York, United States
Advanced Urology Centers of New York
Plainview, New York, United States
Premier Medical Group of the Hudson Valley
Poughkeepsie, New York, United States
Associated Medical Professionals of NY
Syracuse, New York, United States
University of North Carolina Lineberger Cancer Center
Chapel Hill, North Carolina, United States
Carolina Urology Partners, PLLC
Charlotte, North Carolina, United States
Carolina Urology Partners
Concord, North Carolina, United States
The Urology Group
Cincinnati, Ohio, United States
Clinical Research Solutions
Middleburg Heights, Ohio, United States
Oregon Urology Institute
Springfield, Oregon, United States
Lancaster Urology
Lancaster, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
UPMC Cancer Centers
Pittsburgh, Pennsylvania, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Urology Associates Clinical Research
Nashville, Tennessee, United States
Urology Clinics of North Texas
Dallas, Texas, United States
Texas Oncology/Baylor University Medical Center
Dallas, Texas, United States
Urology San Antonio
San Antonio, Texas, United States
Virginia Urology
Richmond, Virginia, United States
Urology of Virginia
Virginia Beach, Virginia, United States
The University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States
St. George Private Hospital, Oncology Day Care Centre
Kogarah, New South Wales, Australia
Ashford Cancer Centre/Adelaide Cancer Centre Research
Kurralta Park, New South Wales, Australia
North Coast Cancer Institute
Port Macquarie, New South Wales, Australia
Prince of Wales Hospital
Randwick, New South Wales, Australia
Macquarie University
Sydney, New South Wales, Australia
Peninsula Specialist Centre
Kippa-Ring, Queensland, Australia
ICON Cancer Care
Southport, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Ashford Cancer Centre/Adelaide Cancer Centre Research
Kurralta Park, South Australia, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Monash Medical Centre
East Bentleigh, Victoria, Australia
Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia
Cabrini Hospital
Malvern, Victoria, Australia
Jules Bordet Institute Clinique d'Oncologie Medicale
Brussels, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
Jessa Ziekenhuis
Hasselt, , Belgium
CHU Sart Tilman
Liège, , Belgium
British Columbia Cancer
Kelowna, British Columbia, Canada
British Columbia Cancer
Vancouver, British Columbia, Canada
London Health Sciences Centre
London, Ontario, Canada
Sunnybrook Research Institute
Toronto, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Centre Hospitalier De I'Universite de Montreal
Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Quebec
Québec, Quebec, Canada
Centre Paul Papin
Angers, , France
Institut Sainte Catherine
Avignon, , France
Institut Bergonié
Bordeaux, , France
Centre François Baclesse
Caen, , France
Service de Médecine Interne Onco-Hématologie
La Roche-sur-Yon, , France
Clinique Victor Hugo Centre Jean Bernard
Le Mans, , France
Centre Léon Bérard
Lyon, , France
Hôpital Edouard Herriot
Lyon, , France
Centre Antoine Lacassagne
Nice, , France
Centre René Gauducheau
Saint-Herblain, , France
Institut de Cancérologie de l'Ouest
Saint-Herblain, , France
Institut de Cancerlogie de la Loire
Saint-Priest-en-Jarez, , France
Institut Gustave-Roussy
Villejuif, , France
Centro Oncologico c/o Presidio Ospedaliero San Donato - Arezzo
Arezzo, , Italy
Unità Operativa di Oncologia Ospedale Civile degli Infe
Faenza (RA), , Italy
Romagnolo per lo Studio e la Cura dei Tumori IRST-IRCCS - Oncologia medica
Meldola (FC), , Italy
AOU "S. Luigi", SCDU Oncologia Medica
Orbassano (Torino), , Italy
Az. Ospedaliera San Camillo-Forlanini
Roma, , Italy
University of Turin
Torino, , Italy
Santa Chiara Hospital
Trento, , Italy
Hospital Clínic i Provincial de Barcelona-Oncology
Barcelona, , Spain
Instituto Catalan de Oncologia (Hospital Durans i Reynals)
Barcelona, , Spain
Hospital General Universitario de Elche
Elche, , Spain
Hospital General Universitario Gregorio Marañón
Madrid, , Spain
Spanish National Cancer Research Centre
Madrid, , Spain
Fundación Althaia Manresa
Manresa, , Spain
Unidad Cnio Ibima de Investigacion en Prostata
Málaga, , Spain
Hospital Son Espases - Oncología
Palma de Mallorca, , Spain
Hospital Clinico Universitario de Navarra
Pamplona, , Spain
Consorci Hospitalari de Parc Taulí
Sabadell, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
IVO-Oncología Médica
Valencia, , Spain
CR-UK Institute for Cancer Studies
Birmingham, England, United Kingdom
Sussex Cancer Centre
Brighton, England, United Kingdom
University College of London Hospitals
London, England, United Kingdom
Guy's and St. Thomas' NHS Foundation Trust
London, England, United Kingdom
Southampton General Hospital
Southampton, England, United Kingdom
University of Surrey Post Graduate Medical Hospital
Surrey, England, United Kingdom
Royal Marsden Hospital
Surrey, England, United Kingdom
The Royal Cornwall Hospital
Truro, England, United Kingdom
The Beatson West of Scotland Cancer Centre
Glasgow, Scotland, United Kingdom
Velindre Hospital
Cardiff, Wales, United Kingdom
Countries
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References
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Aragon-Ching JB. The promising role of poly(ADP-ribose) polymerase inhibitors in prostate cancer. Asian J Androl. 2016 Jul-Aug;18(4):592-3. doi: 10.4103/1008-682X.172821.
Other Identifiers
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ARMOR3-SV
Identifier Type: -
Identifier Source: org_study_id
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