<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/NCT03774056</url>
  </required_header>
  <id_info>
    <org_study_id>HC-1119-01</org_study_id>
    <nct_id>NCT03774056</nct_id>
  </id_info>
  <brief_title>A Study Evaluating Tolerability, Pharmacokinetics, and Preliminary Efficacy of HC-1119 in Patients.</brief_title>
  <official_title>A Phase I Study Evaluating Tolerability, Pharmacokinetics, and Preliminary Efficacy of HC-1119 in Patients With Metastatic Castration-Resistant Prostate Cancer.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hinova Pharmaceuticals Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>West China Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hinova Pharmaceuticals Inc.</source>
  <oversight_info>
    <has_dmc>Yes</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 is a phase I study evaluating tolerability, pharmacokinetics, and preliminary efficacy&#xD;
      of HC-1119 in patients with metastatic castration-resistant prostate cancer. The study&#xD;
      objective is to study the tolerability, safety, and dose-limiting toxicities (DLT) of HC-1119&#xD;
      in patients with mCRPC.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 10, 2017</start_date>
  <completion_date type="Actual">August 28, 2019</completion_date>
  <primary_completion_date type="Actual">September 26, 2018</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dose-limiting toxicities(DLT)</measure>
    <time_frame>From the first dose of the study to the 12th week after dose</time_frame>
    <description>Safety measures</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>From the first dose of the study to the 12th week after dose</time_frame>
    <description>Safety measures</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum drug concentration(Cmax)</measure>
    <time_frame>From the first dose of the study to the 12th week after dose</time_frame>
    <description>Single-dose and repeated-dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of maximum drug concentration(Tmax)</measure>
    <time_frame>From the first dose of the study to the 12th week after dose</time_frame>
    <description>Single-dose and repeated-dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under curve from time 0 to 24h (AUC0-24h)</measure>
    <time_frame>From the first dose of the study to the 12th week after dose</time_frame>
    <description>Single-dose and repeated-dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximal PSA Response Rate</measure>
    <time_frame>From the first dose of the study to the 12th week after dose</time_frame>
    <description>Percentage of patients with &gt; 50% decrease in PSA levels from baseline during the 12-week treatment period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response rate of prostate specific antigen (PSA)</measure>
    <time_frame>From the first dose of the study to the 12th week after dose</time_frame>
    <description>Percentage of patients with &gt; 50% decrease in PSA levels from baseline at weeks 6, 8, 10, and 12.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">43</enrollment>
  <condition>Metastatic Castration Resistant Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>dose group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug name L:HC-1119 Dosage: 40 mg, 80 mg, 160 mg, and 200 mg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HC-1119</intervention_name>
    <description>oral</description>
    <arm_group_label>dose group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria (those who meet all of the following are eligible):&#xD;
&#xD;
          1. Voluntarily participated in the study, with understanding of relevant study procedures&#xD;
             and signed informed consent form;&#xD;
&#xD;
          2. Male , ≥18 years old;&#xD;
&#xD;
          3. With histologically or cytologically confirmed prostate cancer, without neuroendocrine&#xD;
             carcinoma or ductal adenocarcinoma;&#xD;
&#xD;
          4. With evidence of metastatic disease (such as bone scan and CT/MRI results);&#xD;
&#xD;
          5. Patients with relapsed, refractory, or progressive disease despite castration (surgery&#xD;
             or chemical) or combined androgen deprivation therapy (Progressive disease is defined&#xD;
             as 1 or more of the following 3 criteria: Serum PSA progression: A minimum of 3 rising&#xD;
             PSA values with an interval of at least 1 week between determinations, resulting in a&#xD;
             final value higher than 50% of the minimum, with a starting PSA value &gt; 2 ng/ml; Soft&#xD;
             tissue disease progression as defined by RECIST 1.1; Bone disease progression defined&#xD;
             by PCWG2 with 2 or more new metastatic lesions on bone scan);&#xD;
&#xD;
          6. Castrate levels of testosterone (&lt; 50 ng/dl) at screening;&#xD;
&#xD;
          7. Bilateral orchiectomy or ongoing androgen deprivation therapy with effective GnRH&#xD;
             analogues;&#xD;
&#xD;
          8. Estimated life expectancy &gt; 6 months;&#xD;
&#xD;
          9. ECOG performance status ≤ 1;&#xD;
&#xD;
         10. Laboratory tests must meet the following criteria:&#xD;
&#xD;
               1. Routine Blood Test: hemoglobin (Hb) ≥ 90 g/L (no blood transfusion within the&#xD;
                  last 14 days); absolute neutrophil count (ANC) ≥ 1.5 x 109/L; platelet count&#xD;
                  (PLT) ≥ 80 x 109/L;&#xD;
&#xD;
               2. Blood Biochemistry: creatinine (Cr) ≤ 2 x upper limit of normal (ULN), or Cr &gt; 2&#xD;
                  x ULN but the calculated CrCl ≥ 60 mL/min; bilirubin (BIL) ≤ 2 x ULN; alanine&#xD;
                  aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 2.5 x ULN (or ≤ 5.0 x&#xD;
                  ULN for patients with liver metastases);&#xD;
&#xD;
               3. Coagulation: INR &lt; 1.5.&#xD;
&#xD;
        Exclusion Criteria (those who meet any one of the following are ineligible):&#xD;
&#xD;
          1. Ongoing toxicity ( ≥ Grade 2 toxicity) from previous treatments;&#xD;
&#xD;
          2. Clinically significant GI dysfunction which may affect the intake, transport, or&#xD;
             absorption of drug (such as inability to swallow, chronic diarrhea, and bowel&#xD;
             obstruction, etc.), or patients with complete gastrectomy;&#xD;
&#xD;
          3. History of allergies, or known hypersensitivity to components of the investigational&#xD;
             drug;&#xD;
&#xD;
          4. Brain metastases;&#xD;
&#xD;
          5. Other malignancies within the last 5 years (except for curatively treated non-melanoma&#xD;
             skin cancer);&#xD;
&#xD;
          6. History of organ transplants&#xD;
&#xD;
          7. HIV seropositive;&#xD;
&#xD;
          8. Past medical history of seizures or serious CNS diseases;&#xD;
&#xD;
          9. History of unexplained coma;&#xD;
&#xD;
         10. Family history of seizures;&#xD;
&#xD;
         11. History of traumatic brain injury;&#xD;
&#xD;
         12. History of medication or drug abuse;&#xD;
&#xD;
         13. Patients with severe cardiovascular diseases, including those with myocardial&#xD;
             infarction, arterial thrombosis, unstable angina, or clinical symptomatic heart&#xD;
             failure within the past 6 months;&#xD;
&#xD;
         14. Uncontrolled hypertension (systolic ≥ 160 mmHg or diastolic ≥ 100 mmHg). Patients with&#xD;
             a history of hypertension is eligible if his blood pressure is controlled with&#xD;
             antihypertensives;&#xD;
&#xD;
         15. Medications that lower the seizure threshold must be used during the study;&#xD;
&#xD;
         16. Treatment with 5α-reductase inhibitors (finasteride, dutasteride), estrogen, or&#xD;
             cyproterone within the past 4 weeks;&#xD;
&#xD;
         17. Treatment with ketoconazole within the past 4 weeks;&#xD;
&#xD;
         18. Previously treated with investigational or approved medications that inhibit&#xD;
             testosterone synthesis (such as abiraterone acetate, TAK-683, and TAK-448) or target&#xD;
             testosterone receptors (such as enzalutamide, SHR3680, proxalutamide, and ARN509);&#xD;
&#xD;
         19. Participated in other clinical trials within 1 month prior to enrollment;&#xD;
&#xD;
         20. Subjects is determined by the investigator to be unsuitable for this study.&#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_official>
    <last_name>Feng Bi, professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>West China Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Li Zheng, professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>West China Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hinova Pharmaceuticals Inc.</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <last_update_submitted>October 30, 2020</last_update_submitted>
  <last_update_submitted_qc>October 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 3, 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>
  <!-- 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/NCT03774056
org study id: HC-1119-01
nct id: NCT03774056
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a phase I study evaluating tolerability, pharmacokinetics, and preliminary efficacy
      of HC-1119 in patients with metastatic castration-resistant prostate cancer. The study
      objective is to study the tolerability, safety, and dose-limiting toxicities (DLT) of HC-1119
      in patients with mCRPC.
allocation: N/A
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Dose-limiting toxicities(DLT)
time frame: From the first dose of the study to the 12th week after dose
description: Safety measures
measure: Number of patients with adverse events
time frame: From the first dose of the study to the 12th week after dose
description: Safety measures
measure: Maximum drug concentration(Cmax)
time frame: From the first dose of the study to the 12th week after dose
description: Single-dose and repeated-dose
measure: Time of maximum drug concentration(Tmax)
time frame: From the first dose of the study to the 12th week after dose
description: Single-dose and repeated-dose
measure: Area under curve from time 0 to 24h (AUC0-24h)
time frame: From the first dose of the study to the 12th week after dose
description: Single-dose and repeated-dose
measure: Maximal PSA Response Rate
time frame: From the first dose of the study to the 12th week after dose
description: Percentage of patients with > 50% decrease in PSA levels from baseline during the 12-week treatment period
measure: Response rate of prostate specific antigen (PSA)
time frame: From the first dose of the study to the 12th week after dose
description: Percentage of patients with > 50% decrease in PSA levels from baseline at weeks 6, 8, 10, and 12.
arm group label: dose group
arm group type: Experimental
description: Drug name L:HC-1119 Dosage: 40 mg, 80 mg, 160 mg, and 200 mg
intervention type: Drug
intervention name: HC-1119
description: oral
arm group label: dose group
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Feng Bi, professor
role: Principal Investigator
affiliation: West China Hospital
last name: Li Zheng, professor
role: Principal Investigator
affiliation: West China Hospital
facility: 
country: China
responsible party type: Sponsor
mesh term: Prostatic Neoplasms