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

March 13, 2023 updated by: LTN PHARMACEUTICALS, INC.

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)

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

953

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Enzalutamide
Drug: Enzalutamide
160 mg enzalutamide capsules once daily PO
Other Names:
  • Xtandi®
Experimental: Galeterone
Drug: Galeterone
2550 mg galeterone tablets once daily PO
Other Names:
  • TOK-001

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Radiographic Progression-free survival
Time Frame: ≥ 8 months
≥ 8 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: ≥ 8 months
≥ 8 months
Time to Initiation of Cytotoxic Chemotherapy
Time Frame: ≥ 8 months
≥ 8 months

Other Outcome Measures

Outcome Measure
Time Frame
Skeletal-related Events
Time Frame: ≥ 8 months
≥ 8 months
Safety measured by clinical safety laboratories and adverse events
Time Frame: ≥ 8 months
≥ 8 months
Prostate Specific Antigen (PSA) Response ≥ 50%
Time Frame: ≥ 8 months
≥ 8 months
Time to PSA progression
Time Frame: ≥ 8 months
≥ 8 months
Time to ECOG deterioration
Time Frame: ≥ 8 months
≥ 8 months
Best Overall Response by RECIST 1.1
Time Frame: ≥ 8 months
≥ 8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LTN PHARMACEUTICALS, INC.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

March 19, 2015

First Submitted That Met QC Criteria

May 5, 2015

First Posted (Estimate)

May 8, 2015

Study Record Updates

Last Update Posted (Actual)

March 15, 2023

Last Update Submitted That Met QC Criteria

March 13, 2023

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARMOR3-SV

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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