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

Prostate Cancer Clinical Trial

— ARMOR3-SV  

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02438007
• Other study ID #: ARMOR3-SV
• Status: Terminated
• Phase: Phase 3
• Start date: June 2015
• Est. completion date: November 2016

Study information

• Verified date: September 2017
• Source: LTN PHARMACEUTICALS, INC.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 953
• Est. completion date: November 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Galeterone
2550 mg galeterone tablets once daily PO
• Enzalutamide
160 mg enzalutamide capsules once daily PO

Locations

Country	Name	City	State
Australia	Box Hill Hospital	Box Hill	Victoria
Australia	Monash Medical Centre	East Bentleigh	Victoria
Australia	Peter MacCallum Cancer Centre	East Melbourne	Victoria
Australia	Peninsula Specialist Centre	Kippa-Ring	Queensland
Australia	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	Ashford Cancer Centre/Adelaide Cancer Centre Research	Kurralta Park	South Australia
Australia	Cabrini Hospital	Malvern	Victoria
Australia	North Coast Cancer Institute	Port Macquarie	New South Wales
Australia	Prince of Wales Hospital	Randwick	New South Wales
Australia	ICON Cancer Care	Southport	Queensland
Australia	Macquarie University	Sydney	New South Wales
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland
Belgium	Jules Bordet Institute Clinique d'Oncologie Medicale	Brussels
Belgium	Universitair Ziekenhuis Gent	Gent
Belgium	Jessa Ziekenhuis	Hasselt
Belgium	CHU Sart Tilman	Liège
Canada	British Columbia Cancer	Kelowna	British Columbia
Canada	London Health Sciences Centre	London	Ontario
Canada	Centre Hospitalier De I'Universite de Montreal	Montreal	Quebec
Canada	Centre Hospitalier Universitaire de Quebec	Quebec City	Quebec
Canada	Princess Margaret Hospital	Toronto	Ontario
Canada	Sunnybrook Research Institute	Toronto	Ontario
Canada	British Columbia Cancer	Vancouver	British Columbia
France	Centre Paul Papin	Angers Cedex 9
France	Institut Sainte Catherine	Avignon
France	Institut Bergonié	Bordeaux
France	Centre François Baclesse	Caen Cedex
France	Service de Médecine Interne Onco-Hématologie	La Roche Sur Yon Cedex 9
France	Clinique Victor Hugo Centre Jean Bernard	Le Mans
France	Centre Léon Bérard	Lyon
France	Hôpital Edouard Herriot	Lyon
France	Centre Antoine Lacassagne	Nice Cedex 2
France	Institut de Cancérologie de l'Ouest	Saint Herblain
France	Institut de Cancerlogie de la Loire	Saint Priest en Jarez
France	Centre René Gauducheau	Saint-Herblain
France	Institut Gustave-Roussy	Villejuif
Italy	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
Spain	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	Unidad Cnio Ibima de Investigacion en Prostata	Malaga
Spain	Fundación Althaia Manresa	Manresa
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	Sevilla
Spain	IVO-Oncología Médica	Valencia
United Kingdom	CR-UK Institute for Cancer Studies	Birmingham	England
United Kingdom	Sussex Cancer Centre	Brighton	England
United Kingdom	Velindre Hospital	Cardiff	Wales
United Kingdom	The Beatson West of Scotland Cancer Centre	Glasgow	Scotland
United Kingdom	Guy's and St. Thomas' NHS Foundation Trust	London	England
United Kingdom	University College of London Hospitals	London	England
United Kingdom	Southampton General Hospital	Southampton	England
United Kingdom	Royal Marsden Hospital	Surrey	England
United Kingdom	University of Surrey Post Graduate Medical Hospital	Surrey	England
United Kingdom	The Royal Cornwall Hospital	Truro	England
United States	University of Michigan Health System	Ann Arbor	Michigan
United States	University of Colorado Cancer Center Anschultz Cancer Pavilion	Aurora	Colorado
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland
United States	University of Maryland Greenenbaum Cancer Center	Baltimore	Maryland
United States	Walter Reed National Military Medical Center	Bethesda	Maryland
United States	Boca Raton Community Hospital, Inc.	Boca Raton	Florida
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Coastal Urology Associates	Brick	New Jersey
United States	Brooklyn Urology Research Group	Brooklyn	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	The Urology Group	Cincinnati	Ohio
United States	Carolina Urology Partners	Concord	North Carolina
United States	Texas Oncology/Baylor University Medical Center	Dallas	Texas
United States	Urology Clinics of North Texas	Dallas	Texas
United States	The Urology Center of Colorado	Denver	Colorado
United States	Karmanos Cancer Center	Detroit	Michigan
United States	City of Hope	Duarte	California
United States	First Urology	Jeffersonville	Indiana
United States	Lancaster Urology	Lancaster	Pennsylvania
United States	UCLA Jonsson Comprehensive Cancer Center	Los Angeles	California
United States	USC Norris Comprehensive Cancer Center	Los Angeles	California
United States	The University of Wisconsin Paul P. Carbone Comprehensive Cancer Center	Madison	Wisconsin
United States	Prostate Oncology Specialists, Inc.	Marina Del Rey	California
United States	Clinical Research Solutions	Middleburg Heights	Ohio
United States	Carolina Urologic Research Center	Myrtle Beach	South Carolina
United States	Urology Associates Clinical Research	Nashville	Tennessee
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Tulane Medical Center	New Orleans	Louisiana
United States	Urology Cancer Center and GU Research Network	Omaha	Nebraska
United States	University of Florida Health Cancer Center	Orlando	Florida
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	UPMC Cancer Centers	Pittsburgh	Pennsylvania
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	Virginia Urology	Richmond	Virginia
United States	UC Davis Cancer Center	Sacramento	California
United States	Urology San Antonio	San Antonio	Texas
United States	San Bernardino Urological Associates	San Bernardino	California
United States	Pinnacle Oncology Hematology	Scottsdale	Arizona
United States	Regional Urology, LLC	Shreveport	Louisiana
United States	Oregon Urology Institute	Springfield	Oregon
United States	Associated Medical Professionals of NY	Syracuse	New York
United States	Moffitt Cancer Center	Tampa	Florida
United States	Urology Speciality Group	Torrance	California
United States	University Of Arizona Cancer Center	Tucson	Arizona
United States	Urology of Virginia	Virginia Beach	Virginia
United States	Georgetown University Medical Center	Washington	District of Columbia
United States	Sibley Memorial Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
LTN PHARMACEUTICALS, INC.

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  France,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Skeletal-related Events		= 8 months
Other	Safety measured by clinical safety laboratories and adverse events		= 8 months
Other	Prostate Specific Antigen (PSA) Response = 50%		= 8 months
Other	Time to PSA progression		= 8 months
Other	Time to ECOG deterioration		= 8 months
Other	Best Overall Response by RECIST 1.1		= 8 months
Primary	Radiographic Progression-free survival		= 8 months
Secondary	Overall Survival		= 8 months
Secondary	Time to Initiation of Cytotoxic Chemotherapy		= 8 months