A Phase I/II three-part study in prostate cancer

• Research type

  Research Study

• Full title

  PHASE I/II, MULTI-CENTER, OPEN LABEL STUDY TO ASSESS THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS AND ANTI-TUMOR ACTIVITY OF ASP9521 IN PATIENTS WITH METASTATIC CASTRATE-RESISTANT PROSTATE CANCER

• IRAS ID

  69152

• Contact name

  Johann DeBono

• Sponsor organisation

  Astellas Pharma B.V.

• Eudract number

  2010-023382-22

• ISRCTN Number

  not issued

• Research summary

  Prostate cancer growth is dependent on a hormone known as testosterone, and blocking testosterone action has been the mainstay of treatment. The investigational drug to be used, ASP-9521, in this study it is expected to reduce testosterone levels in the adrenal gland and prostate cancer tissue and so slow the growth of prostate cancer cells.This is a phase I/II trial divided into 3 parts for administrative purposes. It will be performed in hospitals that specialise in Phase I and/or Phase II trials. Approximately 204 male patients (>18 years old) with 'castrate resistant' prostate cancer (CRPC) will be enrolled in multiple centres in the UK and the rest of Europe. All patients will receive verbal and written information on the study and provide signed informed consent. They will then undergo screening investigations to confirm their suitability for participation in the trial. During the trial patients will undergo various safety procedures to monitor their health including:ECGsblood testseye testsphysical examshealth questionnaire completion Part I (Phase I) is a dose escalation part testing varying doses of ASP9521 (30-1200mg/day) to establish the highest safest dose (maximum tolerated dose [MTD] of the drug to be taken forward to Part II (Phase II) and Part III. In addition, pharmacokinetic (PK, how the body handles the drug) and pharmacodynamic (PD, how the drug affects the body) assessments will be made.Part II (Phase II) will primarily test how well the MTD as well as 2 other doses chosen from Part I control prostate cancer. The safety, PK, PD and effect on cancer symptoms will also be assessed.Part III will look at the effect that food has on the PK of the selected dose from Parts I and II. Safety information will also be collected.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  11/LO/0996

• Date of REC Opinion

  24 Aug 2011

• REC opinion

  Further Information Favourable Opinion