Arades-Ext Phase II

• Research type

  Research Study

• Full title

  Safety and tolerability of ODM-201 in patients with castrate resistant prostate cancer: open, non-randomised, uncontrolled, multicentre, extension study to study 3104001

• IRAS ID

  69705

• Contact name

  Nicholas James

• Sponsor organisation

  Orion Corporation Orion Pharma

• Eudract number

  2010-022803-24

• ISRCTN Number

  n/a

• Research summary

  This study allows patients participating in the 3104001 trial with the current formulation of ODM-201 to continue the study treatment in this extension study 3104002 at the same dose level until disease progression or experiencing of any change in health or side effects.The primary objective of this extension study is to gain more information about the long-term safety and tolerability of ODM-201.

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  10/H1208/81

• Date of REC Opinion

  25 Feb 2011

• REC opinion

  Further Information Favourable Opinion