BEZ235 / BKM120 in combination with AA in males with prostate cancer

• Research type

  Research Study

• Full title

  Phase Ib dose finding study of abiraterone acetate plus BEZ235 or BKM120 in patients with castration-resistant prostate cancer

• IRAS ID

  110123

• Contact name

  Johann De-Bono

• Sponsor organisation

  Novartis Pharmaceuticals Corporation

• Eudract number

  2012-002250-23

• ISRCTN Number

  xx

• Research summary

  The purpose of this study is to determine the Maximum Tolerated Dose (MTD) of two experimental drugs, BEZ235 and BKM120 that can be given in combination with abiraterone acetate (AA) in men with castration resistance prostate cancer. Prostate cancer can be hormonal responsive and therefore responds to changes in hormone levels. Current treatment for hormone responsive prostate cancer is 'castration therapy' which is treatment that reduces the available androgen/testosterone/DHT by chemical or surgical means. Once a patients’ prostate cancer gets worse after 'castration therapy' then they are eligible form systemic treatments for metastatic disease. At this point a patient would be eligible for consideration into this study. The first part of the study will determine the maximum tolerated dose of BEZ235 with AA and BKM120 with AA. Therefore the first 2 groups of patients(3-6 patients, one group will be given a pre-defined dose of BKM120 AA and the other group a defined dose of BEZ235 AA. These groups of patients will be closely monitored and any adverse events will be reported and taken into consideration during the dose escalation meeting (DEM). At the DEM if the decision is to dose escalate then further groups of patients will receive higher doses of BKM120 / BEZ235 AA until the MTD is determined for both BEZ235 and BKM120. At this point the dose expansion part of the study will open where further patients will receive either the MTD of BKM120 or the MTD BEZ235 in combination with AA.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  12/LO/1338

• Date of REC Opinion

  24 Sep 2012

• REC opinion

  Favourable Opinion