A Phase 2 Study of the Pharmacokinetics and Pharmacodynamics of galete

• Research type

  Research Study

• Full title

  A Pharmacokinetic and Pharmacodynamic Translational Investigation Trial of Galeterone in Patients with Metastatic Castration Resistant Prostate Cancer

• IRAS ID

  141388

• Contact name

  Johann de Bono

• Contact email

  Johann.DeBono@icr.ac.uk

• Sponsor organisation

  Tokai Pharmaceuticals, Inc.

• Eudract number

  2013-003865-32

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This is a trial to study a new drug called galeterone. Galeterone is an experimental drug which is not yet approved by European Medicines Agency (EMA) as a treatment for prostate cancer. The purpose of this trial is to find out how galeterone moves through the body, to collect further evidence of how much galeterone is effective at treating prostate cancer in men and to gather more information about possible side effects.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  13/LO/1805

• Date of REC Opinion

  12 Feb 2014

• REC opinion

  Further Information Favourable Opinion