Status:
UNKNOWN
SC10914 Monotherapy for the mCRPC With g/s BRCA Mutation
Lead Sponsor:
Jiangxi Qingfeng Pharmaceutical Co. Ltd.
Conditions:
Metastatic Castration Resistant Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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) fo...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Signing informed consent voluntarily;
- Prostate cancer confirmed by histology or cytology;
- Metastatic lesions proved by imaging (CT / MRI / bone scan);
- At least one measurable lesion in accordance with recist1.1;
- deleterious or suspected deleterious germline and/or somatic BRCA-mutated (g/sBRCAm)
- ECOG≤2；
- The expected survival time was more than 3 months;
- Serum testosterone levels ≤ 50 ng/dL (≤ 1.75 nmol/L) at screening.
- Subjects without prior surgical castration must be currently taking and willing to continue luteinizing hormone-releasing hormone (LHRH) analog (agonist or antagonist) therapy throughout the duration of study treatment.
- 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
- 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：
- ANC\<1.5×109/L；
- PLT\<100×109/L；
- Hb\<100g/L；
- TBIL\>1.5×ULN；
- ALT、AST\>2.5×ULN unless liver metastases are present in which case they must be \> 5×ULN；
- Cr \>1.5×ULN。
- Subjects who have impaired cardiac function or clinically significant cardiac diseases, including any of the following:
- Baseline QT interval corrected for heart rate (HR) using Fridericia's formula \>500 msec or congenital long QT syndrome;
- Left ventricular ejection fraction (LVEF) \<50% assessed by echocardiogram;
- Other clinically significant heart disease such as congestive heart failure NYHA Class IV and requiring heart transplant
- 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.
Key Trial Info
Start Date :
August 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2022
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04486937
Start Date
August 30 2020
End Date
June 30 2022
Last Update
July 27 2020
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