<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/NCT03823352</url>
  </required_header>
  <id_info>
    <org_study_id>GHAML-2-001</org_study_id>
    <nct_id>NCT03823352</nct_id>
  </id_info>
  <brief_title>Evaluate Efficacy and Safety/Tolerability Profiles of Antroquinonol in Acute Myeloid Leukemia (AML) Adult Patients</brief_title>
  <official_title>Open-label, Non-randomized, Phase IIa Study to Evaluate Efficacy and Safety/Tolerability Profiles of Antroquinonol in Adult Patients With Relapsed Acute Myeloid Leukemia (AML) or at Initial Diagnosis When no Intensive Treatment is Possible</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Golden Biotechnology Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Golden Biotechnology Corporation</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 is a IIa phase IIa open-label, non-randomized clinical trial of Antroquinonol, capsule,&#xD;
      100 mg (Golden Biotechnology Corporation, Taiwan) in patients with AML.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The given pilot clinical trial of a medicinal product for medical use, is held to evaluate&#xD;
      preliminary efficacy and safety/tolerability profiles of antroquinonol in adult patients with&#xD;
      relapsed AML or at initial diagnosis when no intensive treatment is possible.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 20, 2019</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</primary_completion_date>
  <phase>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>
    <intervention_model_description>Patients will receive Antroquinonol 200 mg BID on Day 1 for 4 weeks or until transfusion of red blood cell or platelet ≧ 2, unacceptable toxicity, non-compliance or withdrawal of consent by the patient, or the investigator decides to discontinue treatment, whichever comes first.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Complete blood count measurements according International Working Group (IWG) response criteria</measure>
    <time_frame>2 weeks</time_frame>
    <description>Evaluation of preliminary efficacy profile of antroquinonol in adult patients with relapsed AML or at initial diagnosis when no intensive treatment is possible.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants alive at 4weeks</measure>
    <time_frame>4 weeks</time_frame>
    <description>patients' situation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants alive at 24 weeks</measure>
    <time_frame>24 weeks</time_frame>
    <description>patients' situation</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Leukemia, Myeloid, Acute</condition>
  <arm_group>
    <arm_group_label>Antroquinonol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive Antroquinonol 200 mg BID on Day 1 for 4 weeks or until transfusion of red blood cell or platelet ≧ 2, unacceptable toxicity, non-compliance or withdrawal of consent by the patient, or the investigator decides to discontinue treatment, whichever comes first.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Antroquinonol</intervention_name>
    <description>Antroquinonol: 100 mg and corn oil 100 mg encapsulated in a gelatin capsule administered orally. Dose will be selected(200mg TID or 300mg TID with SOC) after phase I, then follow up the best dose for 40 Patients for the efficacy.</description>
    <arm_group_label>Antroquinonol</arm_group_label>
    <other_name>Hocena</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Diagnosis of relapsed AML after at least 1 chemotherapy regimen or at initial&#xD;
             diagnosis when no intensive treatment possible (based on standard criteria).&#xD;
&#xD;
          2. Men and women 18 to 70 years of age.&#xD;
&#xD;
          3. ECOG performance status = 0 or 1.&#xD;
&#xD;
          4. Ability to comply with the study requirements and give written informed consent.&#xD;
&#xD;
          5. Expected survival more than 3 months.&#xD;
&#xD;
          6. Patients with preserved reproductive potential agree to use, with their partner,&#xD;
             adequate contraception throughout the study and for 30 days thereafter (contraceptive&#xD;
             methods with reliability greater than 90%: cervical caps with spermicide, diaphragms&#xD;
             with spermicide, condoms with intravaginal spermicide, non-hormonal intrauterine&#xD;
             devices), or true sexual abstinence.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Acute promyelocytic leukemia (APL).&#xD;
&#xD;
          2. Hemoglobin ≤ 7g/dL or platelet ≤ 50,000.&#xD;
&#xD;
          3. Abnormal liver and renal function:&#xD;
&#xD;
               -  Total bilirubin &gt; 2 mg/dL;&#xD;
&#xD;
               -  AST and ALT &gt; 2.5 × ULN;&#xD;
&#xD;
               -  Creatinine &gt; 1.5 × ULN, OR creatinine clearance &lt; 50 mL/min/1.73m2.&#xD;
&#xD;
          4. The subject has not recovered to grade ≤ 1 adverse events due to investigational or&#xD;
             chemotherapeutic drugs or stem cell transplantation which were administered &gt; 4 weeks&#xD;
             prior to study enrollment.&#xD;
&#xD;
          5. Patient who has had in the past 3 years any previous or concomitant malignancy EXCEPT&#xD;
             adequately treated basal or squamous cell carcinoma of the skin, in situ carcinoma of&#xD;
             the cervix or bladder, in situ ductal carcinoma of the breast.&#xD;
&#xD;
          6. Subjects with any serious active infection (i.e., requiring an intravenous antibiotic,&#xD;
             antifungal, or antiviral agent).&#xD;
&#xD;
          7. Subjects with known human immunodeficiency virus, active hepatitis B or C.&#xD;
&#xD;
          8. Subjects who have any other life-threatening illness or organ system dysfunction,&#xD;
             which in the opinion of the Investigator, would either compromise subject safety or&#xD;
             interfere with the evaluation of the safety of the study drug.&#xD;
&#xD;
          9. Known or suspected substance abuse or alcohol abuse.&#xD;
&#xD;
         10. Patients with history of seizure disorders or central nervous system leukemia.&#xD;
&#xD;
         11. Patients with uncontrolled, intercurrent illness including, but not limited to,&#xD;
             symptomatic neurological illness; active, uncontrolled, systemic infection considered&#xD;
             opportunistic, life-threatening, or clinically significant at the time of treatment;&#xD;
             symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia;&#xD;
             significant pulmonary disease or hypoxia; or psychiatric illness/social situations&#xD;
             that would limit compliance with study requirements.&#xD;
&#xD;
         12. Inability to swallow oral medications or a recent acute gastrointestinal disorder with&#xD;
             diarrhea e.g., Crohn's disease, malabsorption, or CTCAE Grade &gt; 2 diarrhea of any&#xD;
             etiology at baseline.&#xD;
&#xD;
         13. Prior major surgery or trauma within 28 days prior to first dose of study drug.&#xD;
&#xD;
         14. A positive urine pregnancy test (strip) for female patients of childbearing potential.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>City Clinical Hospital n.a. S.P.Botkin</name>
      <address>
        <city>Moscow</city>
        <zip>125101</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tula Regional Clinical Hospital</name>
      <address>
        <city>Tula</city>
        <zip>300053</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>January 27, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>February 1, 2021</last_update_submitted>
  <last_update_submitted_qc>February 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 3, 2021</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>Leukemia</mesh_term>
    <mesh_term>Leukemia, Myeloid</mesh_term>
    <mesh_term>Leukemia, Myeloid, Acute</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/NCT03823352
org study id: GHAML-2-001
nct id: NCT03823352
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a IIa phase IIa open-label, non-randomized clinical trial of Antroquinonol, capsule,
      100 mg (Golden Biotechnology Corporation, Taiwan) in patients with AML.
The given pilot clinical trial of a medicinal product for medical use, is held to evaluate
      preliminary efficacy and safety/tolerability profiles of antroquinonol in adult patients with
      relapsed AML or at initial diagnosis when no intensive treatment is possible.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Patients will receive Antroquinonol 200 mg BID on Day 1 for 4 weeks or until transfusion of red blood cell or platelet ≧ 2, unacceptable toxicity, non-compliance or withdrawal of consent by the patient, or the investigator decides to discontinue treatment, whichever comes first.
primary purpose: Treatment
masking: None (Open Label)
measure: Complete blood count measurements according International Working Group (IWG) response criteria
time frame: 2 weeks
description: Evaluation of preliminary efficacy profile of antroquinonol in adult patients with relapsed AML or at initial diagnosis when no intensive treatment is possible.
measure: Number of Participants alive at 4weeks
time frame: 4 weeks
description: patients' situation
measure: Number of Participants alive at 24 weeks
time frame: 24 weeks
description: patients' situation
arm group label: Antroquinonol
arm group type: Experimental
description: Patients will receive Antroquinonol 200 mg BID on Day 1 for 4 weeks or until transfusion of red blood cell or platelet ≧ 2, unacceptable toxicity, non-compliance or withdrawal of consent by the patient, or the investigator decides to discontinue treatment, whichever comes first.
intervention type: Drug
intervention name: Antroquinonol
description: Antroquinonol: 100 mg and corn oil 100 mg encapsulated in a gelatin capsule administered orally. Dose will be selected(200mg TID or 300mg TID with SOC) after phase I, then follow up the best dose for 40 Patients for the efficacy.
arm group label: Antroquinonol
other name: Hocena
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
facility: 
country: Russian Federation
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Leukemia, Myeloid
mesh term: Leukemia, Myeloid, Acute
sharing ipd: No