Orteronel (TAK-700) in Castration-Resistant Prostate Cancer Patients

• Research type

  Research Study

• Full title

  A Study in Japan and Ex-Japan to Characterize the Pharmacokinetic and Pharmacodynamic Response to Orteronel (TAK-700) in Chemotherapy-Naïve Patients With Castration-Resistant Prostate Cancer

• IRAS ID

  107891

• Contact name

  Simon Chowdhury

• Sponsor organisation

  Millennium Pharmaceuticals, Inc.

• Eudract number

  2012-001539-30

• ISRCTN Number

  xx

• Research summary

  Prostate cancer is the second most common cancer in men after lung cancer. About 30% of men who receive local treatment have recurrent disease within 10 to 15 years. In most recurrent patients the condition ultimately progresses to metastatic castration resistant prostate cancer (mCRPC) for which there is no cure. Orteronel (TAK-700) is currently in clinical development by Millennium Pharmaceuticals, Inc. as a treatment for men with castration-resistant prostate cancer (CRPC). The purpose of this study is to use blood tests to assess the effect and to measure the levels of the study drug orteronel in the body in patients with CRPC. Approximately 144 male patients at approximately 60 centers will participate in this study worldwide with approximately 10 participants from the UK. The estimated length of participation is approximately 30 months (2« years). The study consists of: Screening period: To see if the participant's suitable. Treatment period: Made up of 28 day cycles Follow up period: After completing Cycle 5, Day 1 assessments, participants may enter into follow-up. They may remain on treatment at the discretion of the investigator returning to the site for follow-up visits. At Cycle 1 patients will be randomly assigned (like flipping a coin) to receive the study drug or placebo (dummy drug) with a 66% chance of receiving orteronel plus prednisone and about a 33% chance of receiving placebo plus prednisone. At Cycle 2, Day 1, patients who were randomly assigned to placebo will begin administration of active treatment with orteronel at the assigned dose. Patients assigned to receive active treatment with orteronel will continue to receive their current dose level. This study involves procedures including: medical history; physical exam; ECG and MUGA or Echo (to measure the health of the heart); CT, MRI, or bone scan; blood and urine samples.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  12/LO/1476

• Date of REC Opinion

  16 Nov 2012

• REC opinion

  Further Information Favourable Opinion