Metastatic Castration Resistant Prostate CancerPhase 1/2mCRPCNCT04486937
SC10914 Monotherapy for the mCRPC With g/s BRCA Mutation
A Phase 1/2 study testing S410914 tablet in people with Metastatic Castration Resistant Prostate Cancer, run by Jiangxi Qingfeng Pharmaceutical Co. Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration Resistant Prostate Cancer
- What is being tested?
- S410914 tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 30 Aug 2020to 30 Jun 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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；
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- 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.
Who cannot join
- 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)
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Sc10914 Monotherapy for Metastatic Castration Resistant Prostate Cancer Patients With Germ and / or Somatic BRCA Mutation: a Single Arm, Multicenter Clinical Tria
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.
Read the 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）.
- Being tested
- S410914 tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S410914 tabletDrug
S410914 tablet
| Study group | Role | What they receive |
|---|---|---|
| SC10914 | Experimental | 400mg TID，oral admination on an fasting state Receives: Drug: S410914 tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate (ORR)
assessed by the independent imaging assessment committee (recist1.1)
Measured: up to 100 weeks (estimated)
Secondary outcomes (3)
PFS
Measured: 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
Measured: up to 100 weeks (estimated)
overall survival (OS)
evaluated according to recist1.1 and adjusted pcwg3 criteria
Measured: up to 100 weeks (estimated)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study start30 Aug 2020 (estimated)
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration Resistant Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangxi Qingfeng Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04486937
- Sponsor's protocol ID
- QF-SC10914-202
- Acronym
- mCRPC
- Status last verified
- Jul 2020
- First submitted
- 20 Jul 2020
- Last updated
- 27 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sc10914 Monotherapy for Metastatic Castration Resistant Prostate Cancer Patients With Germ and / or Somatic BRCA Mutation: a Single Arm, Multicenter Clinical Tria
- ClinicalTrials.gov ID
- NCT04486937
- Acronym / sponsor ID
- mCRPC / QF-SC10914-202
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Jiangxi Qingfeng Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Aug 2020 (estimated)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 27 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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）.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SC10914 | Experimental | Drug: S410914 tablet400mg TID，oral admination on an fasting state |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S410914 tabletS410914 tablet | Drug | SC10914 |
Primary outcome
objective response rate (ORR)
Time frame: up to 100 weeks (estimated)
assessed by the independent imaging assessment committee (recist1.1)
3 secondary outcomes
PFS
Time frame: up to 100 weeks (estimated)
Disease control rate (DCR), duration of response (DOR), time to tumor progression (TTP)
Time frame: up to 100 weeks (estimated)
overall survival (OS)
Time frame: up to 100 weeks (estimated)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing S410914 tablet in people with Metastatic Castration Resistant Prostate Cancer, run by Jiangxi Qingfeng Pharmaceutical Co. Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuping Zhang (18010196244, zhangyuping@sh-qingfeng.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective response rate (ORR) (time frame: up to 100 weeks (estimated)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2020; AzTrials last refreshed its copy on 6 Nov 2026.