SC10914 Monotherapy for the mCRPC With g/s BRCA Mutation (mCRPC)
Primary Purpose
Metastatic Castration Resistant Prostate Cancer
Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
S410914 tablet
Sponsored by

About this trial
This is an interventional treatment trial for Metastatic Castration Resistant Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
- 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.
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:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SC10914
Arm Description
400mg TID,oral admination on an fasting state
Outcomes
Primary Outcome Measures
objective response rate (ORR)
assessed by the independent imaging assessment committee (recist1.1)
Secondary Outcome Measures
PFS
Disease control rate (DCR), duration of response (DOR), time to tumor progression (TTP)
evaluated according to recist1.1 and adjusted pcwg3 criteria
overall survival (OS)
evaluated according to recist1.1 and adjusted pcwg3 criteria
Full Information
NCT ID
NCT04486937
First Posted
July 20, 2020
Last Updated
July 24, 2020
Sponsor
Jiangxi Qingfeng Pharmaceutical Co. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04486937
Brief Title
SC10914 Monotherapy for the mCRPC With g/s BRCA Mutation
Acronym
mCRPC
Official Title
Sc10914 Monotherapy for Metastatic Castration Resistant Prostate Cancer Patients With Germ and / or Somatic BRCA Mutation: a Single Arm, Multicenter Clinical Tria
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 30, 2020 (Anticipated)
Primary Completion Date
December 30, 2021 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangxi Qingfeng Pharmaceutical Co. Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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) for the treatment of BRCA mutations in germ cells and / or somatic cells.
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 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Castration Resistant Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SC10914
Arm Type
Experimental
Arm Description
400mg TID,oral admination on an fasting state
Intervention Type
Drug
Intervention Name(s)
S410914 tablet
Intervention Description
S410914 tablet
Primary Outcome Measure Information:
Title
objective response rate (ORR)
Description
assessed by the independent imaging assessment committee (recist1.1)
Time Frame
up to 100 weeks (estimated)
Secondary Outcome Measure Information:
Title
PFS
Time Frame
up to 100 weeks (estimated)
Title
Disease control rate (DCR), duration of response (DOR), time to tumor progression (TTP)
Description
evaluated according to recist1.1 and adjusted pcwg3 criteria
Time Frame
up to 100 weeks (estimated)
Title
overall survival (OS)
Description
evaluated according to recist1.1 and adjusted pcwg3 criteria
Time Frame
up to 100 weeks (estimated)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
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:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuping Zhang
Phone
18010196244
Email
zhangyuping@sh-qingfeng.net
First Name & Middle Initial & Last Name or Official Title & Degree
Wanwan Ji
Phone
18852605644
Email
jiwanwan@sh-qingfeng.net
12. IPD Sharing Statement
Plan to Share IPD
No
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SC10914 Monotherapy for the mCRPC With g/s BRCA Mutation
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