<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/NCT03778047</url>
  </required_header>
  <id_info>
    <org_study_id>HC-1119-02</org_study_id>
    <nct_id>NCT03778047</nct_id>
  </id_info>
  <brief_title>A Study Evaluating Enzalutamide Pharmacokinetics and Pharmacodynamics, and Related Changes After Drug Switch</brief_title>
  <official_title>A Clinical Study for Evaluating Enzalutamide Pharmacokinetics and Pharmacodynamics, and Related Changes After Drug Switch in Chinese Patients With Metastatic Castration-Resistant Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hinova Pharmaceuticals Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hinova Pharmaceuticals Inc.</source>
  <oversight_info>
    <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 study for evaluating enzalutamide pharmacokinetics and pharmacodynamics, and&#xD;
      related changes after drug switch in Chinese patients with metastatic castration-resistant&#xD;
      prostate cancer. The study primary objective is to evaluate the pharmacokinetic&#xD;
      characteristics of enzalutamide in Chinese patients with mCRPC.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 7, 2018</start_date>
  <completion_date type="Actual">August 28, 2019</completion_date>
  <primary_completion_date type="Actual">October 24, 2018</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum drug concentration(Cmax)</measure>
    <time_frame>From the first dose of the study drug to 12 weeks after dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time of maximum drug concentration(Tmax)</measure>
    <time_frame>From the first dose of the study drug to 12 weeks after dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under curve from time 0 to 24h (AUC0-24h)</measure>
    <time_frame>From the first dose of the study drug to 12 weeks after dose</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum drug concentration(Cmax)</measure>
    <time_frame>From 13 weeks to 24 weeks after dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of maximum drug concentration(Tmax)</measure>
    <time_frame>From 13 weeks to 24 weeks after dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under curve from time 0 to 24h (AUC0-24h)</measure>
    <time_frame>From 13 weeks to 24 weeks after dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>From the first dose of the study drug to 24 weeks after dose</time_frame>
    <description>Safety measures</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with &gt; 50% decrease in prostate specific antigen (PSA)</measure>
    <time_frame>From the first dose of the study drug to 12 weeks after dose</time_frame>
    <description>Percentage of patients with &gt; 50% decrease in PSA levels from baseline at weeks1,3,5 6, 8, 10, and 12.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Metastatic Castration Resistant Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>enzalutamide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>160mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HC-1119</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>To be determined</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Enzalutamide</intervention_name>
    <description>oral</description>
    <arm_group_label>enzalutamide</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HC1119</intervention_name>
    <description>oral</description>
    <arm_group_label>HC-1119</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Voluntarily participated in the study, with understanding of and will to comply with&#xD;
             relevant study procedures and signed informed consent form;&#xD;
&#xD;
          2. Chinese 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 lesions (such as bone scan and CT/MRI);&#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: PSA progression: A minimum of 3 rising PSA&#xD;
             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 progression as defined by&#xD;
             PCWG2 with 2 or more new lesions on bone scan);&#xD;
&#xD;
          6. Castrate levels of testosterone (&lt; 50 ng/dl) at screening; bilateral orchiectomy or&#xD;
             ongoing androgen deprivation therapy with effective GnRH analogues;&#xD;
&#xD;
          7. ECOG performance status ≤1;&#xD;
&#xD;
          8. Laboratory tests must meet the following criteria:&#xD;
&#xD;
               1. Routine Blood Test: hemoglobin (Hb) ≥ 90g/L (no blood transfusions within 14 days&#xD;
                  prior to screening); absolute neutrophil count (ANC) ≥ 1.5 x 109/L; Platelet&#xD;
                  Count (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;
          9. Estimated life expectancy &gt; 6 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Participated in other clinical drug trials within 1 month prior to screening, or the&#xD;
             occurrence of toxicity caused by previous treatments that has not been relieved to ≤&#xD;
             Grade 2 toxicity (according to CTCAE 4.03) prior to enrollment;&#xD;
&#xD;
          2. Brain metastases;&#xD;
&#xD;
          3. Subjects are excluded if any of the following conditions are met:&#xD;
&#xD;
               1. Other malignancies within the last 5 years (except for curatively treated&#xD;
                  non-melanoma skin cancer);&#xD;
&#xD;
               2. History of organ transplants;&#xD;
&#xD;
               3. Past medical history of seizures, serious CNS diseases, or unexplained coma,&#xD;
                  family history of seizures, or history of traumatic brain injury;&#xD;
&#xD;
               4. Uncontrolled hypertension (systolic ≥ 160 mmHg or diastolic ≥ 100 mmHg) or other&#xD;
                  serious cardiovascular diseases. (Patients with a history of hypertension is&#xD;
                  eligible if his blood pressure is controlled with antihypertensives);&#xD;
&#xD;
               5. Significant GI dysfunction which may affect the intake, transport, or absorption&#xD;
                  of drug (such as inability to swallow, chronic diarrhea, and bowel obstruction,&#xD;
                  etc.), or patients with complete gastrectomy;&#xD;
&#xD;
               6. Other uncontrolled clinical diseases, including but not limited to: persistent or&#xD;
                  active infections.&#xD;
&#xD;
          4. Subjects are excluded if any of the following conditions regarding past or concomitant&#xD;
             medication are met:&#xD;
&#xD;
               1. Medications that lower the seizure threshold must be used during the trial;&#xD;
&#xD;
               2. Treatment with 5α-reductase inhibitors (finasteride, dutasteride), estrogen, or&#xD;
                  cyproterone within 4 weeks prior to screening;&#xD;
&#xD;
               3. Treatment with ketoconazole within 4 weeks prior to screening;&#xD;
&#xD;
               4. Previously treated with investigational or approved medications that inhibit&#xD;
                  testosterone synthesis (such as abiraterone acetate, TAK-683, and TAK-448) or&#xD;
                  target testosterone receptors (such as SHR3680, proxalutamide, and ARN509),&#xD;
                  except for bicalutamide and flutamide.&#xD;
&#xD;
          5. Known hypersensitivity to any ingredient of the study drugs (enzalutamide and HC-1119)&#xD;
             or similar drugs;&#xD;
&#xD;
          6. HIV seropositive;&#xD;
&#xD;
          7. History of medication or drug abuse;&#xD;
&#xD;
          8. Other conditions that subject is determined by the investigator to be unsuitable for&#xD;
             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>
  <location>
    <facility>
      <name>Medical Ethics Committee of Hunan Cancer Hospital</name>
      <address>
        <city>Changsha</city>
        <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 16, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 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/NCT03778047
org study id: HC-1119-02
nct id: NCT03778047
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This is a study for evaluating enzalutamide pharmacokinetics and pharmacodynamics, and
      related changes after drug switch in Chinese patients with metastatic castration-resistant
      prostate cancer. The study primary objective is to evaluate the pharmacokinetic
      characteristics of enzalutamide in Chinese patients with mCRPC.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum drug concentration(Cmax)
time frame: From the first dose of the study drug to 12 weeks after dose
measure: Time of maximum drug concentration(Tmax)
time frame: From the first dose of the study drug to 12 weeks after dose
measure: Area under curve from time 0 to 24h (AUC0-24h)
time frame: From the first dose of the study drug to 12 weeks after dose
measure: Maximum drug concentration(Cmax)
time frame: From 13 weeks to 24 weeks after dose
measure: Time of maximum drug concentration(Tmax)
time frame: From 13 weeks to 24 weeks after dose
measure: Area under curve from time 0 to 24h (AUC0-24h)
time frame: From 13 weeks to 24 weeks after dose
measure: Number of patients with adverse events
time frame: From the first dose of the study drug to 24 weeks after dose
description: Safety measures
measure: Percentage of patients with > 50% decrease in prostate specific antigen (PSA)
time frame: From the first dose of the study drug to 12 weeks after dose
description: Percentage of patients with > 50% decrease in PSA levels from baseline at weeks1,3,5 6, 8, 10, and 12.
arm group label: enzalutamide
arm group type: Experimental
description: 160mg
arm group label: HC-1119
arm group type: Experimental
description: To be determined
intervention type: Drug
intervention name: Enzalutamide
description: oral
arm group label: enzalutamide
intervention type: Drug
intervention name: HC1119
description: oral
arm group label: HC-1119
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor
mesh term: Prostatic Neoplasms