Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is a multicenter, single arm phase I / II clinical study in mCRPC subjects who failed to receive docetaxel chemotherapy, abitolone acetate and / or enzalutamide (including its analogues) for the treatment of BRCA mutations in germ cells and / or somatic cells.
The subjects oral administration sc10914 tablets 400mg on an empty stomach, three times a day, for 28 consecutive days as a treatment cycle, until disease progression (PD) (according to Recist1.1 and the adjusted PCWG3 standard, the subjects met the imaging [CT / MRI / bone scan] PD standard) or the toxicity was intolerable.
The study is divided into two stages: in the first stage,enrolled 36 patients whose response can be evaluated, if there are at least 7 cases of objective remission (CR or PR), the second stage is allowed, otherwise the study will be stopped; in the second stage, the number of subjects whose response can be evaluated is planned to continue to be enrolled to 70 cases(stage 1 and stage 2).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SC10914 | Experimental | 400mg TID,oral admination on an fasting state |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S410914 tablet | Drug | S410914 tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| objective response rate (ORR) | assessed by the independent imaging assessment committee (recist1.1) | up to 100 weeks (estimated) |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | up to 100 weeks (estimated) | |
| Disease control rate (DCR), duration of response (DOR), time to tumor progression (TTP) | evaluated according to recist1.1 and adjusted pcwg3 criteria | up to 100 weeks (estimated) |
Not provided
Inclusion Criteria:
9.Subjects must have progressed on prior NHA (e.g. abiraterone acetate and/or enzalutamide) for the treatment of mCRPC. 10.Subjects must have progressed on prior chemotherapy with docetaxel for the treatment of mCRPC.
Exclusion Criteria:
Any previous treatment with PARP inhibitor
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.
Subjects with known brain metastases.
Major surgery within 2 weeks of starting study treatment and subjects must have recovered from any effects of any major surgery
Subjects unable to swallow orally administered medication and subjects with gastrointestinal disorders likely to interfere with Absorption, distribution, metabolism and excretion of the study
Immunocompromised subjects, e.g., subjects who are known to be serologically positive for human immunodeficiency virus (HIV)
Subjects with a known hypersensitivity to SC10914 or any of the excipients of the product
Subjects with known active hepatitis (i.e. Hepatitis B or C)
Subjects with not enough organ functional reserve at baseline, which met at least one of the following criteria:
Subjects who have impaired cardiac function or clinically significant cardiac diseases, including any of the following:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuping Zhang | Contact | 18010196244 | zhangyuping@sh-qingfeng.net | |
| Wanwan Ji | Contact | 18852605644 | jiwanwan@sh-qingfeng.net |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| overall survival (OS) | evaluated according to recist1.1 and adjusted pcwg3 criteria | up to 100 weeks (estimated) |