<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/NCT02245204</url>
  </required_header>
  <id_info>
    <org_study_id>LYS-I-01</org_study_id>
    <nct_id>NCT02245204</nct_id>
  </id_info>
  <brief_title>Phase I Studies of Chlorogenic Acid for Injection for Tolerance and Pharmacokinetic of Advanced Cancers</brief_title>
  <official_title>Phase I Studies of Chlorogenic Acid for Injection for Tolerance and Pharmacokinetic of Advanced Cancers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sichuan J.Z. Bio-chemical Science and Technology Development Co., Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Peking University Cancer Hospital &amp; Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sichuan J.Z. Bio-chemical Science and Technology Development Co., Ltd</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study:&#xD;
&#xD;
      Determining the Maximum Tolerated Dose (MTD), Dose-Limiting Toxicity (DLT), pharmacokinetics&#xD;
      characteristic, and dosage regimen of phase II/III of Chlorogenic acid for injection in the&#xD;
      advanced malignant tumor subjects;&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Investigate the tolerance of Chlorogenic acid for injection in human body, determine the&#xD;
           Maximum Tolerated Dose (MTD) and Dose-Limiting Toxicity (DLT) of Chlorogenic acid for&#xD;
           injection in the advanced malignant tumor subjects;&#xD;
&#xD;
        2. Determine the human pharmacokinetics characteristic of Chlorogenic acid for injection;&#xD;
&#xD;
        3. Preliminary observation the effectiveness and effective dose;&#xD;
&#xD;
        4. Provide the basis for the dosage regimen of phase II/III.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">October 2016</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of adverse events</measure>
    <time_frame>Within the first 60 days after the first dose of chlorogenic acid</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dose-Limiting Toxicity</measure>
    <time_frame>Within the first 30 days after the first dose of chlorogenic acid</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Tolerated Dose</measure>
    <time_frame>Within the first 30 days after the first dose of chlorogenic acid</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration versus time curve (AUC) and Peak Plasma Concentration (Cmax) of chlorogenic acid</measure>
    <time_frame>Within the first 30 days after the first dose of chlorogenic acid</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in cancer-related symptoms and quality of life</measure>
    <time_frame>Within 1 year after the first dose of chlorogenic acid</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Changing in number of red blood cell and level of hemoglobin</measure>
    <time_frame>within 1 year after the first dose of chlorogenic acid</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Changing in the diameters of lymph node metastasis</measure>
    <time_frame>Within 1 year after the first dose of chlorogenic acid</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Changing in levels of tumor markers</measure>
    <time_frame>Within 1 year after the first dose of chlorogenic acid</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Advanced Cancer</condition>
  <arm_group>
    <arm_group_label>Chlorgenic acid, Treatment, powder</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Chlorogenic acid for injection(30mg/bottle) is white or off-white freeze-dried lump or powder,it can be easily dissolved in water, which solubility is 20%.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chlorogenic acid</intervention_name>
    <description>Chlorogenic acid for injection is polyphenols, micromolecular and un-endogenous substance. It might play the role of cancer treatment via balancing tumor micro-environmental immune status according to the stability and rationality of immunodeficiency and endogenous immune material expression around the tumor. Chlorogenic acid for injection is made from chlorogenic acid (purity≥98%) which is extracted from folium cortex eucommiae.Chlorogenic acid and its preparations have not been reported as chemical drug and marketed around the world.</description>
    <arm_group_label>Chlorgenic acid, Treatment, powder</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with pathologic or/and FNAC confirmation of advanced cancer but without&#xD;
             effective treatment or with treatment failure;&#xD;
&#xD;
          2. Between 18 and 65 years of age, KPS≥70;&#xD;
&#xD;
          3. According to RECIST 1.1,patients with at least one tumor lesion that can accurately be&#xD;
             measured by CT or MRI in at least one dimension with longest diameter to be recorded&#xD;
             as &gt;2.0cm by general CT or &gt;1.0cm by spiral CT;&#xD;
&#xD;
          4. Life expectancy of at least three (3) months at the enrollment;&#xD;
&#xD;
          5. Patients who have sufficient baseline organ function and whose laboratory data can&#xD;
             meet the following criteria at the enrollment:&#xD;
&#xD;
               -  PLT count≥100×10~9/L,&#xD;
&#xD;
               -  WLB count≥4.0×10~9/L and ≤12×10~9/L,&#xD;
&#xD;
               -  Neutrophil granulocyte count≥2.0×10~9/L,&#xD;
&#xD;
               -  HGB count≥90g/L,&#xD;
&#xD;
               -  Total bilirubin &lt;=1.5 times of ULN,&#xD;
&#xD;
               -  ALT/AST ≤2.5 times of ULN,&#xD;
&#xD;
               -  SCr≤1.5 times of ULN,&#xD;
&#xD;
               -  Normal ECG with LVEF (≥50%) measured by echocardiography;&#xD;
&#xD;
          6. Female patients with negative pregnant test, and male/female patients of reproductive&#xD;
             age without pregnancy planning in the next 12 months;&#xD;
&#xD;
          7. Volunteered for the phase 1 trial and sign the informed consent without protest;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who have received large area radiotherapy （&gt;30% marrow capacity）;&#xD;
&#xD;
          2. Patients who suffer from other serious complication, such as uncontrollable infection,&#xD;
             myocardial infarction within the past 6 months at the enrollment , uncontrollable&#xD;
             hypertension ,thromboembolism and etc.;&#xD;
&#xD;
          3. Symptomatic patients with brain metastases (except for the patients whose brain&#xD;
             metastases is controlled to stable status after whole brain radiotherapy);&#xD;
&#xD;
          4. Patients who have received the therapy of chemotherapy within 4 weeks before&#xD;
             enrollment;&#xD;
&#xD;
          5. Patients who have used nitrosoureas drug or mitomycin within 6 weeks or tyrosine&#xD;
             kinase inhibitor within 2 weeks before enrollment;&#xD;
&#xD;
          6. Patients who have received therapy of major surgery within 6 weeks or biopsy surgery&#xD;
             within 2 weeks before enrollment;&#xD;
&#xD;
          7. Patients who or have received radical radiotherapy within 6 weeks or local palliative&#xD;
             radiotherapy within 2 weeks before enrollment;&#xD;
&#xD;
          8. Patients who experience grade 2 or more than grade 2 toxicity caused by the past&#xD;
             therapies;&#xD;
&#xD;
          9. Patients who have history of drug abuse or alcoholism;&#xD;
&#xD;
         10. Patients who smoke over 5 cigarettes or equivalent tobacco per day;&#xD;
&#xD;
         11. Uncontrollable psychopaths;&#xD;
&#xD;
         12. Pregnant or breast-feeding women, or patients(male and female) who have pregnancy&#xD;
             plan;&#xD;
&#xD;
         13. Patients who had received a therapy of another investigational drug within 4 weeks or&#xD;
             patients who are still in another clinical trial at the enrollment;&#xD;
&#xD;
         14. Known active hepatitis B/hepatitis C, positive HIV/ syphilis antibody;&#xD;
&#xD;
         15. Patient who need long term treatment of cortical hormone or other immunosuppressive&#xD;
             drugs such as visceral organ transplanters;&#xD;
&#xD;
         16. Allergic to the investigational drug;&#xD;
&#xD;
         17. Other patients judged ineligible for enrollment in the study by the investigator&#xD;
             (sub-investigator).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lin Shen, Dr</last_name>
    <role>Study Chair</role>
    <affiliation>Peking University Cancer Hospital &amp; Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beijing Cancer Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100142</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>September 16, 2014</study_first_submitted>
  <study_first_submitted_qc>September 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <last_update_submitted>November 19, 2018</last_update_submitted>
  <last_update_submitted_qc>November 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 21, 2018</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>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/NCT02245204
org study id: LYS-I-01
nct id: NCT02245204
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study:

      Determining the Maximum Tolerated Dose (MTD), Dose-Limiting Toxicity (DLT), pharmacokinetics
      characteristic, and dosage regimen of phase II/III of Chlorogenic acid for injection in the
      advanced malignant tumor subjects;
1. Investigate the tolerance of Chlorogenic acid for injection in human body, determine the
           Maximum Tolerated Dose (MTD) and Dose-Limiting Toxicity (DLT) of Chlorogenic acid for
           injection in the advanced malignant tumor subjects;

        2. Determine the human pharmacokinetics characteristic of Chlorogenic acid for injection;

        3. Preliminary observation the effectiveness and effective dose;

        4. Provide the basis for the dosage regimen of phase II/III.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of adverse events
time frame: Within the first 60 days after the first dose of chlorogenic acid
measure: Dose-Limiting Toxicity
time frame: Within the first 30 days after the first dose of chlorogenic acid
measure: Maximum Tolerated Dose
time frame: Within the first 30 days after the first dose of chlorogenic acid
measure: Area under the plasma concentration versus time curve (AUC) and Peak Plasma Concentration (Cmax) of chlorogenic acid
time frame: Within the first 30 days after the first dose of chlorogenic acid
measure: Improvement in cancer-related symptoms and quality of life
time frame: Within 1 year after the first dose of chlorogenic acid
measure: Changing in number of red blood cell and level of hemoglobin
time frame: within 1 year after the first dose of chlorogenic acid
measure: Changing in the diameters of lymph node metastasis
time frame: Within 1 year after the first dose of chlorogenic acid
measure: Changing in levels of tumor markers
time frame: Within 1 year after the first dose of chlorogenic acid
arm group label: Chlorgenic acid, Treatment, powder
arm group type: Experimental
description: Chlorogenic acid for injection(30mg/bottle) is white or off-white freeze-dried lump or powder,it can be easily dissolved in water, which solubility is 20%.
intervention type: Drug
intervention name: Chlorogenic acid
description: Chlorogenic acid for injection is polyphenols, micromolecular and un-endogenous substance. It might play the role of cancer treatment via balancing tumor micro-environmental immune status according to the stability and rationality of immunodeficiency and endogenous immune material expression around the tumor. Chlorogenic acid for injection is made from chlorogenic acid (purity≥98%) which is extracted from folium cortex eucommiae.Chlorogenic acid and its preparations have not been reported as chemical drug and marketed around the world.
arm group label: Chlorgenic acid, Treatment, powder
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Lin Shen, Dr
role: Study Chair
affiliation: Peking University Cancer Hospital & Institute
facility: 
country: China
responsible party type: Sponsor
mesh term: Neoplasms