A Phase II Study of PX-866 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer

Inclusion Criteria

• Patients must have a histological or cytological diagnosis of adenocarcinoma of the prostate.
• All patients must have formalin fixed paraffin embedded tissue (from their primary or metastatic tumour) available for translational studies.
• Presence of clinically and/or radiologically documented disease (measureable or non-measurable). All radiology studies must be performed within 28 days prior to registration (within 35 days if negative).
• Androgen ablation must include either medical or surgical castration. If the patient is receiving medical androgen ablation, a castrate level of testosterone ( =3 years.
• Known HIV-positive patients.
• Uncontrolled diabetes mellitus.
• Patients with upper gastrointestinal or other conditions that would preclude compliance or absorption of oral medication are not eligible.
• Patients with active or uncontrolled infections, or with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol.
• Patients are not eligible if they have a known hypersensitivity to the study drug(s) or their components.
• Patients with history of central nervous system metastases or untreated spinal cord compression.
• Patients who have had prior treatment with a PI3 kinase inhibitor.
• Men who are not sterile unless they use an adequate method of birth control.
• Patients enrolled to Part B must be suitable for continued therapy with abiraterone/prednisone.