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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
953

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Bergonié
      • 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 Leon Berard
      • Lyon, France, Cedex 03
        • Hopital Edouard Herriot
      • Nice Cedex 2, France, 06189
        • Centre Antoine Lacassagne
      • Saint Herblain, France, 44805
        • Institut de Cancérologie 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 Marañon
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Radiographic Progression-free survival
Time Frame: ≥ 8 months
≥ 8 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 19, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 8, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 15, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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