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A Study of Galeterone Compared to Enzalutamide In Men Expressing Androgen Receptor Splice Variant-7 mRNA (AR-V7) Metastatic CRPC (ARMOR3-SV)

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ClinicalTrials.gov Identifier: NCT02438007
Recruitment Status : Terminated
First Posted : May 8, 2015
Last Update Posted : September 28, 2017
Sponsor:
Information provided by (Responsible Party):
Novus Therapeutics, Inc

Brief Summary:
The purpose of this study is to compare galeterone to enzalutamide in men expressing androgen receptor spice variant-7 mRNA (AR-V7) in metastatic (M1) castrate resistant prostate cancer (CRPC).

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Galeterone Drug: Enzalutamide Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 953 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ARMOR3-SV: A Phase 3, Randomized, Open Label, Multi-Center, Controlled Study of Galeterone Compared to Enzalutamide in Men Expressing Androgen Receptor Splice Variant-7 mRNA (AR-V7) Metastatic (M1) Castrate Resistant Prostate Cancer (CRPC)
Study Start Date : June 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Galeterone Drug: Galeterone
2550 mg galeterone tablets once daily PO
Other Name: TOK-001

Active Comparator: Enzalutamide Drug: Enzalutamide
160 mg enzalutamide capsules once daily PO
Other Name: Xtandi®




Primary Outcome Measures :
  1. Radiographic Progression-free survival [ Time Frame: ≥ 8 months ]

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: ≥ 8 months ]
  2. Time to Initiation of Cytotoxic Chemotherapy [ Time Frame: ≥ 8 months ]

Other Outcome Measures:
  1. Skeletal-related Events [ Time Frame: ≥ 8 months ]
  2. Safety measured by clinical safety laboratories and adverse events [ Time Frame: ≥ 8 months ]
  3. Prostate Specific Antigen (PSA) Response ≥ 50% [ Time Frame: ≥ 8 months ]
  4. Time to PSA progression [ Time Frame: ≥ 8 months ]
  5. Time to ECOG deterioration [ Time Frame: ≥ 8 months ]
  6. Best Overall Response by RECIST 1.1 [ Time Frame: ≥ 8 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Progressive metastatic (M1) disease on androgen deprivation therapy
  • Detectable AR-V7 from circulating tumors (CTCs)
  • ECOG performance status 0 or 1

Exclusion Criteria:

  • Prior treatment with second generation anti-androgens (e.g. abiraterone, enzalutamide)
  • Prior treatment with chemotherapy for CRPC

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02438007


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Locations
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United States, Arizona
Pinnacle Oncology Hematology
Scottsdale, Arizona, United States, 85258
University Of Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, California
City of Hope
Duarte, California, United States, 91010
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
UCLA Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095
Prostate Oncology Specialists, Inc.
Marina del Rey, California, United States, 90292
UC Davis Cancer Center
Sacramento, California, United States, 95817
San Bernardino Urological Associates
San Bernardino, California, United States, 92404
Urology Speciality Group
Torrance, California, United States, 90505
United States, Colorado
University of Colorado Cancer Center Anschultz Cancer Pavilion
Aurora, Colorado, United States, 80045
The Urology Center of Colorado
Denver, Colorado, United States, 80211
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
United States, District of Columbia
Georgetown University Medical Center
Washington, D.C., District of Columbia, United States, 20007
Sibley Memorial Hospital
Washington, D.C., District of Columbia, United States, 20016
United States, Florida
Boca Raton Community Hospital, Inc.
Boca Raton, Florida, United States, 33486
University of Florida Health Cancer Center
Orlando, Florida, United States, 32806
Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Indiana
First Urology
Jeffersonville, Indiana, United States, 47130
United States, Louisiana
Tulane Medical Center
New Orleans, Louisiana, United States, 70115
Regional Urology, LLC
Shreveport, Louisiana, United States, 71106
United States, Maryland
University of Maryland Greenenbaum Cancer Center
Baltimore, Maryland, United States, 21201
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21205
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20307
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Karmanos Cancer Center
Detroit, Michigan, United States, 48201
United States, Nebraska
Urology Cancer Center and GU Research Network
Omaha, Nebraska, United States, 68130
United States, New Jersey
Coastal Urology Associates
Bricktown, New Jersey, United States, 08724
United States, New York
Brooklyn Urology Research Group
Brooklyn, New York, United States, 11215
Advanced Urology Centers of New York
Plainview, New York, United States, 11803
Premier Medical Group of the Hudson Valley
Poughkeepsie, New York, United States, 12601
Associated Medical Professionals of NY
Syracuse, New York, United States, 13210
United States, North Carolina
University of North Carolina Lineberger Cancer Center
Chapel Hill, North Carolina, United States, 27599
Carolina Urology Partners, PLLC
Charlotte, North Carolina, United States, 28277
Carolina Urology Partners
Concord, North Carolina, United States, 28025
United States, Ohio
The Urology Group
Cincinnati, Ohio, United States, 45212
Clinical Research Solutions
Middleburg Heights, Ohio, United States, 44130
United States, Oregon
Oregon Urology Institute
Springfield, Oregon, United States, 97477
United States, Pennsylvania
Lancaster Urology
Lancaster, Pennsylvania, United States, 17604
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
UPMC Cancer Centers
Pittsburgh, Pennsylvania, United States, 15232
United States, South Carolina
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
United States, Tennessee
Urology Associates Clinical Research
Nashville, Tennessee, United States, 37209
United States, Texas
Urology Clinics of North Texas
Dallas, Texas, United States, 75231
Texas Oncology/Baylor University Medical Center
Dallas, Texas, United States, 75246
Urology San Antonio
San Antonio, Texas, United States, 78229
United States, Virginia
Virginia Urology
Richmond, Virginia, United States, 23235
Urology of Virginia
Virginia Beach, Virginia, United States, 23462
United States, Wisconsin
The University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792
Australia, New South Wales
St. George Private Hospital, Oncology Day Care Centre
Kogarah, New South Wales, Australia, 2217
Ashford Cancer Centre/Adelaide Cancer Centre Research
Kurralta Park, New South Wales, Australia, 5037
North Coast Cancer Institute
Port Macquarie, New South Wales, Australia, 2444
Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031
Macquarie University
Sydney, New South Wales, Australia, 2109
Australia, Queensland
Peninsula Specialist Centre
Kippa-Ring, Queensland, Australia, 4102
ICON Cancer Care
Southport, Queensland, Australia, 4215
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Ashford Cancer Centre/Adelaide Cancer Centre Research
Kurralta Park, South Australia, Australia, 5037
Australia, Victoria
Box Hill Hospital
Box Hill, Victoria, Australia, 3128
Monash Medical Centre
East Bentleigh, Victoria, Australia, 3165
Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia, 3002
Cabrini Hospital
Malvern, Victoria, Australia, 3144
Belgium
Jules Bordet Institute Clinique d'Oncologie Medicale
Brussels, Belgium, B-1000
Universitair Ziekenhuis Gent
Gent, Belgium, B-9000
Jessa Ziekenhuis
Hasselt, Belgium, B-3500
CHU Sart Tilman
Liège, Belgium, 4000
Canada, British Columbia
British Columbia Cancer
Kelowna, British Columbia, Canada, V1Y 5L3
British Columbia Cancer
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, N6A 4L6
Sunnybrook Research Institute
Toronto, Ontario, Canada, M4N 3M5
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Centre Hospitalier De I'Universite de Montreal
Montreal, Quebec, Canada, H2L 4M1
Centre Hospitalier Universitaire de Quebec
Quebec City, Quebec, Canada, G1R 3S1
France
Centre Paul Papin
Angers Cedex 9, France, 49055
Institut Sainte Catherine
Avignon, France, 84918
Institut Bergonié
Bordeaux, France, 33076
Centre François Baclesse
Caen Cedex, France, 14076
Service de Médecine Interne Onco-Hématologie
La Roche Sur Yon Cedex 9, France, 85925
Clinique Victor Hugo Centre Jean Bernard
Le Mans, France, 72000
Centre Léon Bérard
Lyon, France, 69008
Hôpital Edouard Herriot
Lyon, France, Cedex 03
Centre Antoine Lacassagne
Nice Cedex 2, France, 06189
Institut de Cancérologie de l'Ouest
Saint Herblain, France, 44805
Institut de Cancerlogie de la Loire
Saint Priest en Jarez, France, 42271
Centre René Gauducheau
Saint-Herblain, France, 44805
Institut Gustave-Roussy
Villejuif, France, 94805
Italy
Centro Oncologico c/o Presidio Ospedaliero San Donato - Arezzo
Arezzo, Italy, 52100
Unità Operativa di Oncologia Ospedale Civile degli Infe
Faenza (RA), Italy, 48018
Romagnolo per lo Studio e la Cura dei Tumori IRST-IRCCS - Oncologia medica
Meldola (FC), Italy, 47014
AOU "S. Luigi", SCDU Oncologia Medica
Orbassano (Torino), Italy, 10043
Az. Ospedaliera San Camillo-Forlanini
Roma, Italy, 00152
University of Turin
Torino, Italy, 10126
Santa Chiara Hospital
Trento, Italy, 38122
Spain
Hospital Clínic i Provincial de Barcelona-Oncology
Barcelona, Spain, 08036
Instituto Catalan de Oncologia (Hospital Durans i Reynals)
Barcelona, Spain, 08908
Hospital General Universitario de Elche
Elche, Spain, 3203
Hospital General Universitario Gregorio Marañón
Madrid, Spain, 28009
Spanish National Cancer Research Centre
Madrid, Spain, 28050
Unidad Cnio Ibima de Investigacion en Prostata
Malaga, Spain
Fundación Althaia Manresa
Manresa, Spain, 08243
Hospital Son Espases - Oncología
Palma de Mallorca, Spain, 07010
Hospital Clinico Universitario de Navarra
Pamplona, Spain, 31008
Consorci Hospitalari de Parc Taulí
Sabadell, Spain, 08208
Hospital Universitario Virgen del Rocio
Sevilla, Spain, 41013
IVO-Oncología Médica
Valencia, Spain, 46009
United Kingdom
CR-UK Institute for Cancer Studies
Birmingham, England, United Kingdom, B15 2PR
Sussex Cancer Centre
Brighton, England, United Kingdom, BN2 5BE
University College of London Hospitals
London, England, United Kingdom, NWI 2PG
Guy's and St. Thomas' NHS Foundation Trust
London, England, United Kingdom, SE1 9RT
Southampton General Hospital
Southampton, England, United Kingdom, SO16 6YD
University of Surrey Post Graduate Medical Hospital
Surrey, England, United Kingdom, GU2 7WG
Royal Marsden Hospital
Surrey, England, United Kingdom, SM2 5PT
The Royal Cornwall Hospital
Truro, England, United Kingdom, TR1 3LJ
The Beatson West of Scotland Cancer Centre
Glasgow, Scotland, United Kingdom, G12 0YN
Velindre Hospital
Cardiff, Wales, United Kingdom, CF14 2TL
Sponsors and Collaborators
Novus Therapeutics, Inc

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Novus Therapeutics, Inc
ClinicalTrials.gov Identifier: NCT02438007     History of Changes
Other Study ID Numbers: ARMOR3-SV
First Posted: May 8, 2015    Key Record Dates
Last Update Posted: September 28, 2017
Last Verified: September 2017
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens
3-hydroxy-17-(1H-benzimidazole-1-yl)androsta-5,16-diene
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action