Study of TGF-β Receptor Inhibitor Galunisertib (LY2157299) and Enzalutamide in Metastatic Castration-resistant Prostate Cancer

Exclusion Criteria

• •Known history or evidence of brain metastases
• •Prior chemotherapy for metastatic disease in castration-resistant prostate cancer
• •Had surgery within 4 weeks prior to the first dose of study drug
• •Had radiation, biological, or other investigational cancer therapy within 2 weeks prior to the first dose of study drug
• •Had second-line hormonal therapy within 2 weeks prior to the first dose of study drug
• •Systemic steroids within 1 weeks prior to the first dose of study drug
• •Had prior enzalutamide, ARN-509, or galeterone therapy
• •Have moderate or severe cardiovascular disease
• •Have a history of a seizure
• •Have uncontrolled intercurrent illness, including but not limited to ongoing or active infection, systematic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric condition that would limit compliance with study requirements
• •Have a history of any autoimmune disease:inflammatory bowel disease, (including ulcerative colitis and Crohn's Disease), rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythmatosus (SLE) autoimmune vasculitis (e.g., Wegener's Granulomatosis), central nervous system (CNS) or motor neuropathy considered to be of autoimmune origin (e.g., Guillian-Barre Syndrome, Myasthenia Gravis, Multiple Sclerosis)
• •Have known history of infection with HIV, hepatitis B, or hepatitis C