A Phase Ib Multicentre Study of AZD5363 Monotherapy to Assess Anti-Tumour Activity, Safety, Tolerability, and Pharmacokinetics in Patients With Metastatic Castrate-Resistant Prostate Cancer (mCRPC) (PYRUS)

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