The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02438007
Ethics application status
Date submitted
19/03/2015
Date registered
8/05/2015
Date last updated
28/09/2017

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
Gender
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
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Louisiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Nebraska
Country [13] 0 0
United States of America
State/province [13] 0 0
New Jersey
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Oregon
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
South Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Tennessee
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
Country [22] 0 0
United States of America
State/province [22] 0 0
Virginia
Country [23] 0 0
United States of America
State/province [23] 0 0
Wisconsin
Country [24] 0 0
Belgium
State/province [24] 0 0
Brussels
Country [25] 0 0
Belgium
State/province [25] 0 0
Gent
Country [26] 0 0
Belgium
State/province [26] 0 0
Hasselt
Country [27] 0 0
Belgium
State/province [27] 0 0
Liège
Country [28] 0 0
Canada
State/province [28] 0 0
British Columbia
Country [29] 0 0
Canada
State/province [29] 0 0
Ontario
Country [30] 0 0
Canada
State/province [30] 0 0
Quebec
Country [31] 0 0
France
State/province [31] 0 0
Angers Cedex 9
Country [32] 0 0
France
State/province [32] 0 0
Avignon
Country [33] 0 0
France
State/province [33] 0 0
Bordeaux
Country [34] 0 0
France
State/province [34] 0 0
Caen Cedex
Country [35] 0 0
France
State/province [35] 0 0
La Roche Sur Yon Cedex 9
Country [36] 0 0
France
State/province [36] 0 0
Le Mans
Country [37] 0 0
France
State/province [37] 0 0
Lyon
Country [38] 0 0
France
State/province [38] 0 0
Nice Cedex 2
Country [39] 0 0
France
State/province [39] 0 0
Saint Herblain
Country [40] 0 0
France
State/province [40] 0 0
Saint Priest en Jarez
Country [41] 0 0
France
State/province [41] 0 0
Saint-Herblain
Country [42] 0 0
France
State/province [42] 0 0
Villejuif
Country [43] 0 0
Italy
State/province [43] 0 0
Arezzo
Country [44] 0 0
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
State/province [49] 0 0
Trento
Country [50] 0 0
Spain
State/province [50] 0 0
Barcelona
Country [51] 0 0
Spain
State/province [51] 0 0
Elche
Country [52] 0 0
Spain
State/province [52] 0 0
Madrid
Country [53] 0 0
Spain
State/province [53] 0 0
Malaga
Country [54] 0 0
Spain
State/province [54] 0 0
Manresa
Country [55] 0 0
Spain
State/province [55] 0 0
Palma de Mallorca
Country [56] 0 0
Spain
State/province [56] 0 0
Pamplona
Country [57] 0 0
Spain
State/province [57] 0 0
Sabadell
Country [58] 0 0
Spain
State/province [58] 0 0
Sevilla
Country [59] 0 0
Spain
State/province [59] 0 0
Valencia
Country [60] 0 0
United Kingdom
State/province [60] 0 0
England
Country [61] 0 0
United Kingdom
State/province [61] 0 0
Scotland
Country [62] 0 0
United Kingdom
State/province [62] 0 0
Wales

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novus Therapeutics, Inc
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/show/NCT02438007
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

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02438007