This research study is a Phase I clinical trial. Phase I clinical trials test the safety of
an investigational drug, in this case an investigational drug combined with standard drug
therapy. Phase I studies also try to define the appropriate dose of the investigational drug
to use for further studies. "Investigational" means that the drug is still being studied and
taht research doctors are trying to find out more about it. It also means that the FDA has
not approved the drug for use in patients, including people with your type of cancer.
BKM120 is a drug that inhibits the ability of tumors to grow and survive, which may lead to
better outcomes in many types of cancer.
Abiraterone acetate is a drug that is approved for the treatment of prostate cancer, and
works by inhibiting an enzyme found in prostate tumor tissue. While taking abiraterone
acetate, individuals must also take a glucocorticoid such as prednisone.
Most patients with castrate-resistant prostate cancer will receive treatment with docetaxel,
after which treatment with the combination of abiraterone and prednisone has been shown to be
effective. Evidence has shown an interaction between the pathways through which BKM120 and
abiraterone act on cancer. Therefore, it is thought that the treatment of castrate-resistant
prostate cancer will be enhanced by combining BKM120 with abiraterone plus prednisone. The
purpose of this study is to determine a safe dose for the combination of daily oral BKM120,
abiraterone acetate, and prednisone in patients with castrate-resistant metastatic prostate
cancer who have received prior treatment with docetaxel.