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Galeterone - Phase 3 Clinical trial in Australia


Paul Edwards

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Paul Edwards

Trial stopped - see below.

Men who are on androgen deprivation therapy and who have metastases may be interested in the following Phase 3 clinical trial:
A Study of Galeterone Compared to Enzalutamide In Men Expressing Androgen Receptor Splice Variant-7 mRNA (AR-V7) Metastatic CRPC (ARMOR3-SV)

 

Details of this trial are available at XXXXXXXXX

 

 

To be eligible, you must not have been treated with abiraterone, enzalutamide or chemotherapy.  You must have detectable AR-V7 (your circulating tumour cells will be tested as part of the eligibility process).

 

If accepted for the trial, you will receive active drugs, not placebos.  You will receive either Galeterone or Enzalutamide.

 

 

Galeterone (TOK-001) is a new steroidal antiandrogen under development by Tokai Pharmaceuticals for the treatment of prostate cancer.  It possesses a unique dual mechanism of action, acting as both an androgen receptor antagonist and an inhibitor of CYP17A1, an enezyme required for the biosynthesis of the androgens.  Galeterone may benefit men who carry the AR-V7 subtype of Castrate Resistant Prostate Cancer and who therefore do not respond well to treatment with either abiraterone or enzalutamide.

 

 

The trial is currently recruiting participants at the following Australian trial sites listed below:

 

Peter MacCallum Cancer Centre, 2 St. Andrews Place, East Melbourne, VIC, 3002

 

North Coast Cancer Institute,Wrights Road, Port Macquarie, NSW, 2444

 

Ashford Cancer Centre/Adelaide Cancer Centre Research, 520 South Road, Kurralta Park, NSW, 5037

 

Box Hill Hospital, Monash University and Eastern Health Clinical School,  Level 2, 5 Arnold Street, Box Hill, VIC, 3128

 

Macquarie University, Urology Macquarie University Clinic Suite 304 Level 3, 2 Technology Place, Sydney, NSW, 2109

 

Cabrini Hospital,Suite 19, 183 Wattletree Rd, Malvern, VIC, 3144, AU

 

ICON Cancer Care, 39 White Street, Southport, QLD 4215

 

Monash Medical Centre, East Bentleigh, 865 Centre Road, East Bentleigh, VIC, 3165

 

Peninsula Specialist Centre, 101 George Street, Kippa-Ring, QLD 4021

 

Princess Alexandra Hospital, Ipswich Road, Woollongabba, QLD, 4102

 

St. George Private Hospital, Oncology Day Care Centre, 1 South Street, Kogarah, NSW, 2217

Edited by Admin
Trial cancelled
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Charles (Chuck) Maack

I would HIGHLY RECOMMEND that men who have not yet moved to Xtandi/enzalutamide or Zytiga/abiraterone treatment, and whose usual ADT medications are showing failure, to take advantage of this trial.  The trial will first determine if the AR-V7 splice variant is in your system to then qualify you for the trial.  And I will be very interested in future results of the effectiveness  of Galeterone in enzalutamide then being effective.  Currently, men with this variant who are prescribed either enzalutamide or abiraterone acetate find the effectivenesss very short lived within weeks or just a few months.  Galeterone is expected to permit much improved effectiveness of these two medications.  I compiled a paper regarding this problem for your review if interested:  XTANDI/enzalutamide or ZYTIGA/abiraterone acetate Being Considered?

WAIT! TRIAL Cancelled - see below.

Edited by Admin
Trial cancelled
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  • 6 months later...

Galeterone trial stopped

Based on a review of all safety and efficacy data, the Data Monitoring Committee (DMC) determined that the ARMOR3-SV trial will likely not succeed in meeting its primary endpoint of demonstrating an improvement in radiographic progression-free survival (rPFS) for galeterone versus enzalutamide in AR-V7 positive mCRPC. In making its recommendation, the DMC did not cite any safety concerns with galeterone in the trial.

 

Tokai plans to allow all patients currently enrolled in the ARMOR2 and ARMOR3-SV trials to continue on therapy following consultation with their physicians and study investigators.

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Galeterone trial stopped

Based on a review of all safety and efficacy data, the Data Monitoring Committee (DMC) determined that the ARMOR3-SV trial will likely not succeed in meeting its primary endpoint of demonstrating an improvement in radiographic progression-free survival (rPFS) for galeterone versus enzalutamide in AR-V7 positive mCRPC. In making its recommendation, the DMC did not cite any safety concerns with galeterone in the trial.

 

Tokai plans to allow all patients currently enrolled in the ARMOR2 and ARMOR3-SV trials to continue on therapy following consultation with their physicians and study investigators.

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