Safety, Preliminary Efficacy and Pharmacokinetics of ASN001 in Metastatic Castrate Resistant Prostate Cancer

Exclusion Criteria

• •Patients with rapidly progressive disease who are candidates for other approved therapies such as docetaxel, abiraterone, and enzalutamide.
• •Prior therapy with abiraterone, orteronel, ketoconazole, or any other Cytochrome P450 (CYP) 17 lyase inhibitor; enzalutamide or other experimental androgen receptor antagonist; or experimental immunotherapy agent.
• •History of impaired adrenal gland function
• •Any investigational treatments for any condition within 4 weeks prior to the start of study treatment.
• •Therapy with herbal products known to effect PSA, or estrogen within 30 days prior to the start of study medication
• •Known gastrointestinal disease or condition that affects the absorption of ASN001, or difficulty swallowing large capsules.
• •Use of systemic glucocorticoid (eg, prednisone, dexamethasone) within 14 days prior to the start of study medication
• •Major surgery within 30 days of study medication
• •Known brain metastasis
• •Previous history of another cancer within 5 years, except completely removed basal or squamous cell skin cancer.
• •Serious concurrent medical conditions including: serious heart disease, heart conduction abnormalities, persistent infection, uncontrolled psychiatric illness, liver cirrhosis, chronic liver disease, active or symptomatic viral hepatitis, any other condition that may place the subject at an increased risk or confound the results of the study.