<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04486937</url>
  </required_header>
  <id_info>
    <org_study_id>QF-SC10914-202</org_study_id>
    <nct_id>NCT04486937</nct_id>
  </id_info>
  <brief_title>SC10914 Monotherapy for the mCRPC With g/s BRCA Mutation</brief_title>
  <acronym>mCRPC</acronym>
  <official_title>Sc10914 Monotherapy for Metastatic Castration Resistant Prostate Cancer Patients With Germ and / or Somatic BRCA Mutation: a Single Arm, Multicenter Clinical Tria</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jiangxi Qingfeng Pharmaceutical Co. Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jiangxi Qingfeng Pharmaceutical Co. Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a multicenter, single arm phase I / II clinical study in mCRPC subjects who&#xD;
      failed to receive docetaxel chemotherapy, abitolone acetate and / or enzalutamide (including&#xD;
      its analogues) for the treatment of BRCA mutations in germ cells and / or somatic cells.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The subjects oral administration sc10914 tablets 400mg on an empty stomach, three times a&#xD;
      day, for 28 consecutive days as a treatment cycle, until disease progression (PD) (according&#xD;
      to Recist1.1 and the adjusted PCWG3 standard, the subjects met the imaging [CT / MRI / bone&#xD;
      scan] PD standard) or the toxicity was intolerable.&#xD;
&#xD;
      The study is divided into two stages: in the first stage,enrolled 36 patients whose response&#xD;
      can be evaluated, if there are at least 7 cases of objective remission (CR or PR), the second&#xD;
      stage is allowed, otherwise the study will be stopped; in the second stage, the number of&#xD;
      subjects whose response can be evaluated is planned to continue to be enrolled to 70&#xD;
      cases（stage 1 and stage 2）.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 30, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2021</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>objective response rate (ORR)</measure>
    <time_frame>up to 100 weeks (estimated)</time_frame>
    <description>assessed by the independent imaging assessment committee (recist1.1)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PFS</measure>
    <time_frame>up to 100 weeks (estimated)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease control rate (DCR), duration of response (DOR), time to tumor progression (TTP)</measure>
    <time_frame>up to 100 weeks (estimated)</time_frame>
    <description>evaluated according to recist1.1 and adjusted pcwg3 criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>overall survival (OS)</measure>
    <time_frame>up to 100 weeks (estimated)</time_frame>
    <description>evaluated according to recist1.1 and adjusted pcwg3 criteria</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Metastatic Castration Resistant Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>SC10914</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>400mg TID，oral admination on an fasting state</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>S410914 tablet</intervention_name>
    <description>S410914 tablet</description>
    <arm_group_label>SC10914</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Signing informed consent voluntarily;&#xD;
&#xD;
          2. Prostate cancer confirmed by histology or cytology;&#xD;
&#xD;
          3. Metastatic lesions proved by imaging (CT / MRI / bone scan);&#xD;
&#xD;
          4. At least one measurable lesion in accordance with recist1.1;&#xD;
&#xD;
          5. deleterious or suspected deleterious germline and/or somatic BRCA-mutated (g/sBRCAm)&#xD;
&#xD;
          6. ECOG≤2；&#xD;
&#xD;
          7. The expected survival time was more than 3 months;&#xD;
&#xD;
          8. Serum testosterone levels ≤ 50 ng/dL (≤ 1.75 nmol/L) at screening.&#xD;
&#xD;
          9. Subjects without prior surgical castration must be currently taking and willing to&#xD;
             continue luteinizing hormone-releasing hormone (LHRH) analog (agonist or antagonist)&#xD;
             therapy throughout the duration of study treatment.&#xD;
&#xD;
        9.Subjects must have progressed on prior NHA (e.g. abiraterone acetate and/or enzalutamide)&#xD;
        for the treatment of mCRPC. 10.Subjects must have progressed on prior chemotherapy with&#xD;
        docetaxel for the treatment of mCRPC.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any previous treatment with PARP inhibitor&#xD;
&#xD;
          2. Concomitant use of known strong CYP3A inhibitors or moderate CYP3A inhibitors. The&#xD;
             required washout period prior to starting olaparib is 2 weeks or 5 half-life.&#xD;
&#xD;
          3. Subjects with known brain metastases.&#xD;
&#xD;
          4. Major surgery within 2 weeks of starting study treatment and subjects must have&#xD;
             recovered from any effects of any major surgery&#xD;
&#xD;
          5. Subjects unable to swallow orally administered medication and subjects with&#xD;
             gastrointestinal disorders likely to interfere with Absorption, distribution,&#xD;
             metabolism and excretion of the study&#xD;
&#xD;
          6. Immunocompromised subjects, e.g., subjects who are known to be serologically positive&#xD;
             for human immunodeficiency virus (HIV)&#xD;
&#xD;
          7. Subjects with a known hypersensitivity to SC10914 or any of the excipients of the&#xD;
             product&#xD;
&#xD;
          8. Subjects with known active hepatitis (i.e. Hepatitis B or C)&#xD;
&#xD;
          9. Subjects with not enough organ functional reserve at baseline, which met at least one&#xD;
             of the following criteria：&#xD;
&#xD;
               1. ANC&lt;1.5×109/L；&#xD;
&#xD;
               2. PLT&lt;100×109/L；&#xD;
&#xD;
               3. Hb&lt;100g/L；&#xD;
&#xD;
               4. TBIL&gt;1.5×ULN；&#xD;
&#xD;
               5. ALT、AST&gt;2.5×ULN unless liver metastases are present in which case they must be &gt;&#xD;
                  5×ULN；&#xD;
&#xD;
               6. Cr &gt;1.5×ULN。&#xD;
&#xD;
         10. Subjects who have impaired cardiac function or clinically significant cardiac&#xD;
             diseases, including any of the following:&#xD;
&#xD;
               1. Baseline QT interval corrected for heart rate (HR) using Fridericia's formula&#xD;
                  &gt;500 msec or congenital long QT syndrome;&#xD;
&#xD;
               2. Left ventricular ejection fraction (LVEF) &lt;50% assessed by echocardiogram;&#xD;
&#xD;
               3. Other clinically significant heart disease such as congestive heart failure NYHA&#xD;
                  Class IV and requiring heart transplant&#xD;
&#xD;
         11. Severe bone injury caused by tumor bone metastases as judged by the researchers,&#xD;
             including severe bone pain due to poor control, pathological fracture of important&#xD;
             parts or spinal cord compression occurred or expected to occur in the near future in&#xD;
             the last 6 months.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Yuping Zhang</last_name>
    <phone>18010196244</phone>
    <email>zhangyuping@sh-qingfeng.net</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Wanwan Ji</last_name>
    <phone>18852605644</phone>
    <email>jiwanwan@sh-qingfeng.net</email>
  </overall_contact_backup>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>July 24, 2020</last_update_submitted>
  <last_update_submitted_qc>July 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04486937
org study id: QF-SC10914-202
nct id: NCT04486937
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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）.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: objective response rate (ORR)
time frame: up to 100 weeks (estimated)
description: assessed by the independent imaging assessment committee (recist1.1)
measure: PFS
time frame: up to 100 weeks (estimated)
measure: Disease control rate (DCR), duration of response (DOR), time to tumor progression (TTP)
time frame: up to 100 weeks (estimated)
description: evaluated according to recist1.1 and adjusted pcwg3 criteria
measure: overall survival (OS)
time frame: up to 100 weeks (estimated)
description: evaluated according to recist1.1 and adjusted pcwg3 criteria
arm group label: SC10914
arm group type: Experimental
description: 400mg TID，oral admination on an fasting state
intervention type: Drug
intervention name: S410914 tablet
description: S410914 tablet
arm group label: SC10914
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yuping Zhang
phone: 18010196244
email: zhangyuping@sh-qingfeng.net
last name: Wanwan Ji
phone: 18852605644
email: jiwanwan@sh-qingfeng.net
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
sharing ipd: No