SC10914 Monotherapy for the mCRPC With g/s BRCA Mutation

Exclusion Criteria

• •1. Any previous treatment with PARP inhibitor
• •2. Concomitant use of known strong CYP3A inhibitors or moderate CYP3A inhibitors. The required washout period prior to starting olaparib is 2 weeks or 5 half-life.
• •3. Subjects with known brain metastases.
• •4. Major surgery within 2 weeks of starting study treatment and subjects must have recovered from any effects of any major surgery
• •5. Subjects unable to swallow orally administered medication and subjects with gastrointestinal disorders likely to interfere with Absorption, distribution, metabolism and excretion of the study
• •6. Immunocompromised subjects, e.g., subjects who are known to be serologically positive for human immunodeficiency virus (HIV)
• •7. Subjects with a known hypersensitivity to SC10914 or any of the excipients of the product
• •8. Subjects with known active hepatitis (i.e. Hepatitis B or C)
• •9. Subjects with not enough organ functional reserve at baseline, which met at least one of the following criteria：
• •1. ANC\<1.5×109/L；
• •2. PLT\<100×109/L；
• •3. Hb\<100g/L；
• •4. TBIL\>1.5×ULN；
• •5. ALT、AST\>2.5×ULN unless liver metastases are present in which case they must be \> 5×ULN；
• •6. Cr \>1.5×ULN。
• •10. Subjects who have impaired cardiac function or clinically significant cardiac diseases, including any of the following:
• •1. Baseline QT interval corrected for heart rate (HR) using Fridericia's formula \>500 msec or congenital long QT syndrome;
• •2. Left ventricular ejection fraction (LVEF) \<50% assessed by echocardiogram;
• •3. Other clinically significant heart disease such as congestive heart failure NYHA Class IV and requiring heart transplant
• •11. Severe bone injury caused by tumor bone metastases as judged by the researchers, including severe bone pain due to poor control, pathological fracture of important parts or spinal cord compression occurred or expected to occur in the near future in the last 6 months.