Investigating Safety, Tolerability and Efficacy of AZD5363 in Prostate Cancer.

Inclusion Criteria:

Provision of informed consent
Males aged 18 years and older
Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features for which no standard therapy is currently considered appropriate
Documented evidence of Metastatic Castrate-Resistant Prostate Cancer (mCRPC)
Part A: Patients must have received prior docetaxel-based chemotherapy for mCRPC and have a Circulating Tumour Cell score of 5;
Part B: Patients must have progressed before receiving any chemotherapy for mCRPC;

Exclusion Criteria:

Any prior exposure to agents which inhibit AKT as the primary pharmacological activity
Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, or active infection including hepatitis B, hepatitis C, and human immunodeficiency virus
Spinal cord compression or brain metastases unless asymptomatic, treated, and stable and not requiring steroids
Clinically significant abnormalities of glucose metabolism
Major surgery within the previous 4 weeks