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New Clinical Trial of Galeterone (TOK-001)

Paul Edwards

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Trial stopped - see below

Thanks for Chuck Maack for alerting us to this.


Galeterone (TOK-001) is a highly selective, multi-targeted, oral small molecule, drug candidate for the treatment of prostate cancer that disrupts androgen receptor (AR) signalling, the key driver of prostate cancer growth, via multiple mechanisms of action:

  • androgen receptor degradation, which reduces the amount of androgen receptor protein in the tumor cells;
  • inhibition of the enzyme CYP17, which blocks the synthesis of testosterone; and
  • androgen receptor antagonism, which blocks the binding of testosterone or DHT (dihydrotestoterone) with the androgen receptor.


Tokai Pharmaceuticals, the manufacturer of Galeterone, has started to enroll  US patients into a randomized Phase III clinical trial of treatment with Galeterone.  Patients will be randomized to treatment with either Galeterone or Enzalutamide.



There will be Australian study locations commencing shortly.



Click for more information.

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  • 1 year 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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