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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02438007




Registration number
NCT02438007
Ethics application status
Date submitted
19/03/2015
Date registered
8/05/2015
Date last updated
15/03/2023

Titles & IDs
Public title
A Study of Galeterone Compared to Enzalutamide In Men Expressing Androgen Receptor Splice Variant-7 mRNA (AR-V7) Metastatic CRPC
Scientific 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)
Secondary ID [1] 0 0
ARMOR3-SV
Universal Trial Number (UTN)
Trial acronym
ARMOR3-SV
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Galeterone
Treatment: Drugs - Enzalutamide

Experimental: Galeterone -

Active comparator: Enzalutamide -


Treatment: Drugs: Galeterone
2550 mg galeterone tablets once daily PO

Treatment: Drugs: Enzalutamide
160 mg enzalutamide capsules once daily PO
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Radiographic Progression-free survival
Timepoint [1] 0 0
= 8 months
Secondary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
= 8 months
Secondary outcome [2] 0 0
Time to Initiation of Cytotoxic Chemotherapy
Timepoint [2] 0 0
= 8 months

Eligibility
Key inclusion criteria
* Progressive metastatic (M1) disease on androgen deprivation therapy
* Detectable AR-V7 from circulating tumors (CTCs)
* ECOG performance status 0 or 1
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior treatment with second generation anti-androgens (e.g. abiraterone, enzalutamide)
* Prior treatment with chemotherapy for CRPC

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2016
Sample size
Target
Accrual to date
Final
953
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
St. George Private Hospital, Oncology Day Care Centre - Kogarah
Recruitment hospital [2] 0 0
Ashford Cancer Centre/Adelaide Cancer Centre Research - Kurralta Park
Recruitment hospital [3] 0 0
North Coast Cancer Institute - Port Macquarie
Recruitment hospital [4] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [5] 0 0
Macquarie University - Sydney
Recruitment hospital [6] 0 0
Peninsula Specialist Centre - Kippa-Ring
Recruitment hospital [7] 0 0
ICON Cancer Care - Southport
Recruitment hospital [8] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [9] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [10] 0 0
Monash Medical Centre - East Bentleigh
Recruitment hospital [11] 0 0
Peter MacCallum Cancer Centre - East Melbourne
Recruitment hospital [12] 0 0
Cabrini Hospital - Malvern
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [3] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [4] 0 0
2031 - Randwick
Recruitment postcode(s) [5] 0 0
2109 - Sydney
Recruitment postcode(s) [6] 0 0
4102 - Kippa-Ring
Recruitment postcode(s) [7] 0 0
4215 - Southport
Recruitment postcode(s) [8] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [9] 0 0
3128 - Box Hill
Recruitment postcode(s) [10] 0 0
3165 - East Bentleigh
Recruitment postcode(s) [11] 0 0
3002 - East Melbourne
Recruitment postcode(s) [12] 0 0
3144 - Malvern
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
State/province [2] 0 0
California
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Colorado
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United States of America
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Connecticut
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United States of America
State/province [5] 0 0
District of Columbia
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Florida
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United States of America
State/province [7] 0 0
Indiana
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United States of America
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Louisiana
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United States of America
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Maryland
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United States of America
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Massachusetts
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United States of America
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Michigan
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Nebraska
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New Jersey
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New York
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United States of America
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North Carolina
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Ohio
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Oregon
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Virginia
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United States of America
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Wisconsin
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Belgium
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Brussels
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Belgium
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Gent
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Belgium
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Hasselt
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Belgium
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Liège
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Canada
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British Columbia
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Canada
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Ontario
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Canada
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Quebec
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France
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Angers Cedex 9
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France
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Avignon
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France
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Bordeaux
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France
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Caen Cedex
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France
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La Roche Sur Yon Cedex 9
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France
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Le Mans
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France
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Lyon
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France
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Nice Cedex 2
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France
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Saint Herblain
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France
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Saint Priest en Jarez
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France
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Saint-Herblain
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France
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Villejuif
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Italy
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Arezzo
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Italy
State/province [44] 0 0
Faenza (RA)
Country [45] 0 0
Italy
State/province [45] 0 0
Meldola (FC)
Country [46] 0 0
Italy
State/province [46] 0 0
Orbassano (Torino)
Country [47] 0 0
Italy
State/province [47] 0 0
Roma
Country [48] 0 0
Italy
State/province [48] 0 0
Torino
Country [49] 0 0
Italy
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Trento
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Spain
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Barcelona
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Spain
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Elche
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Spain
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Madrid
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Spain
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Malaga
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Manresa
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Palma de Mallorca
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Pamplona
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Sabadell
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Sevilla
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Valencia
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England
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United Kingdom
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Scotland
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United Kingdom
State/province [62] 0 0
Wales

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
LTN PHARMACEUTICALS, INC.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02438007