<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/NCT04471064</url>
  </required_header>
  <id_info>
    <org_study_id>HY-XY0206-Ⅰ-02</org_study_id>
    <nct_id>NCT04471064</nct_id>
  </id_info>
  <brief_title>A Study of XY0206 Tablets in Patients With Relapsed / Refractory Acute Myeloid Leukemia</brief_title>
  <official_title>A Multicenter, Open, Dose Increasing Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Primary Efficacy of xy0206 Tablets in Relapsed / Refractory Acute Myeloid Leukemia Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shijiazhuang Yiling Pharmaceutical Co. Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Proswell Medical Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Shijiazhuang Yiling 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>
      1. To evaluate the safety and tolerability of xy0206 as single drug in the treatment of&#xD;
           relapsed / refractory AML;&#xD;
&#xD;
        2. Evaluate the dose limited toxicity (DLT) and maximum tolerable dose (MTD) of xy0206 as&#xD;
           single drug in the treatment of relapsed / refractory AML subjects.&#xD;
&#xD;
        3. To evaluate the pharmacokinetic (PK), pharmacokinetic (PD) characteristics and PK / PD&#xD;
           correlation of xy0206 as single drug treatment in relapsed / refractory AML subjects;&#xD;
&#xD;
        4. To evaluate the primary efficacy of xy0206 as single drug in the treatment of relapsed /&#xD;
           refractory AML patients;&#xD;
&#xD;
        5. To evaluate biomarkers of xy0206 as single drug treatment for relapsed / refractory AML&#xD;
           subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 15, 2020</start_date>
  <completion_date type="Anticipated">February 2024</completion_date>
  <primary_completion_date type="Anticipated">February 2024</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 tolerable dose</measure>
    <time_frame>from the start of the medication to the end of the study or 28 days after cessation of medication</time_frame>
    <description>The occurrence of Maximum tolerable dose.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dose limiting toxicity</measure>
    <time_frame>from the start of the medication to the end of the study or 28 days after cessation of medication</time_frame>
    <description>The occurrence of Dose limiting toxicity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adverse event</measure>
    <time_frame>from the start of the medication to the end of the study or 28 days after cessation of medication</time_frame>
    <description>The occurrence rate of Adverse event.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adverse drug reactions</measure>
    <time_frame>from the start of the medication to the end of the study or 28 days after cessation of medication</time_frame>
    <description>The occurrence rate of adverse drug reactions.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serious adverse events</measure>
    <time_frame>from the start of the medication to the end of the study or 28 days after cessation of medication</time_frame>
    <description>The occurrence rate of Serious adverse events.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood routine</measure>
    <time_frame>from the start of the medication to the end of the study or 28 days after cessation of medication</time_frame>
    <description>Check whether the red blood cell system, white blood cell system and platelet system are normal</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Urine routine</measure>
    <time_frame>from the start of the medication to the end of the study or 28 days after cessation of medication</time_frame>
    <description>Urine routine examination includes urine color, transparency, pH, red blood cells, white blood cells, epithelial cells, tube type, protein, specific gravity and urine sugar.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stool routine</measure>
    <time_frame>from the start of the medication to the end of the study or 28 days after cessation of medication</time_frame>
    <description>Routine stool tests include the detection of red and white blood cells in feces, bacterial sensitivity test, occult blood test (OB) and inspection of eggs.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood biochemistry</measure>
    <time_frame>from the start of the medication to the end of the study or 28 days after cessation of medication</time_frame>
    <description>The contents of various ions, sugars, lipids, proteins, enzymes, hormones and metabolites in blood were detected</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum amylase / lipase</measure>
    <time_frame>from the start of the medication to the end of the study or 28 days after cessation of medication</time_frame>
    <description>Evaluation of pancreatic function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Coagulation function</measure>
    <time_frame>from the start of the medication to the end of the study or 28 days after cessation of medication</time_frame>
    <description>Four coagulation parameters including prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT) and fibrinogen (FIB) were evaluated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ECG</measure>
    <time_frame>from the start of the medication to the end of the study or 28 days after cessation of medication</time_frame>
    <description>Evaluation of QT interval</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Echocardiography</measure>
    <time_frame>from the start of the medication to the end of the study or 28 days after cessation of medication</time_frame>
    <description>To evaluate the electrophysiological condition of the heart</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Imaging examination</measure>
    <time_frame>from the start of the medication to the end of the study or 28 days after cessation of medication</time_frame>
    <description>Chest X-ray/CT</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body temperature</measure>
    <time_frame>from the start of the medication to the end of the study or 28 days after cessation of medication</time_frame>
    <description>One of the vital signs.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>from the start of the medication to the end of the study or 28 days after cessation of medication</time_frame>
    <description>Assess whether systolic blood pressure and diastolic blood pressure are normal</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Heart rate</measure>
    <time_frame>from the start of the medication to the end of the study or 28 days after cessation of medication</time_frame>
    <description>One of the vital signs.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Breathing</measure>
    <time_frame>from the start of the medication to the end of the study or 28 days after cessation of medication</time_frame>
    <description>Assess if breathing is normal</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Skin</measure>
    <time_frame>from the start of the medication to the end of the study or 28 days after cessation of medication</time_frame>
    <description>Assess if the skin is normal.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Head</measure>
    <time_frame>from the start of the medication to the end of the study or 28 days after cessation of medication</time_frame>
    <description>Head examination includes head, eyes, ears, nose, lips, etc.Assess if head is normal</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neck</measure>
    <time_frame>from the start of the medication to the end of the study or 28 days after cessation of medication</time_frame>
    <description>Neck examination includes thyroid gland, lymph node, etc.Assess if neck is normal.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Chest</measure>
    <time_frame>from the start of the medication to the end of the study or 28 days after cessation of medication</time_frame>
    <description>Chest examination includes lung, cardiovascular, etc.Assess if chest is normal.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Abdomen</measure>
    <time_frame>from the start of the medication to the end of the study or 28 days after cessation of medication</time_frame>
    <description>Abdominal examination includes liver and spleen.Assess if abdomen is normal.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Limbs</measure>
    <time_frame>from the start of the medication to the end of the study or 28 days after cessation of medication</time_frame>
    <description>Assess if limbs is normal.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Nerves</measure>
    <time_frame>from the start of the medication to the end of the study or 28 days after cessation of medication</time_frame>
    <description>Assess nerve function by communication</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Back/spine</measure>
    <time_frame>from the start of the medication to the end of the study or 28 days after cessation of medication</time_frame>
    <description>Assess if back/spine is normal.</description>
  </primary_outcome>
  <number_of_arms>7</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Acute Myeloid Leukemia</condition>
  <arm_group>
    <arm_group_label>XY0206-12.5mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug:XY0206;Dosage form:Tablet;Dosage：12.5mg; multiple dose phase</description>
  </arm_group>
  <arm_group>
    <arm_group_label>XY0206-25mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug:XY0206;Dosage form:Tablet;Dosage：25mg; multiple dose phase</description>
  </arm_group>
  <arm_group>
    <arm_group_label>XY0206-50mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug:XY0206;Dosage form:Tablet;Dosage：50mg; multiple dose phase</description>
  </arm_group>
  <arm_group>
    <arm_group_label>XY0206-100mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug:XY0206;Dosage form:Tablet;Dosage：100mg; multiple dose phase</description>
  </arm_group>
  <arm_group>
    <arm_group_label>XY0206-150mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug:XY0206;Dosage form:Tablet;Dosage：150mg; multiple dose phase</description>
  </arm_group>
  <arm_group>
    <arm_group_label>XY0206-200mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug:XY0206;Dosage form:Tablet;Dosage：200mg; multiple dose phase</description>
  </arm_group>
  <arm_group>
    <arm_group_label>XY0206-250mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug:XY0206;Dosage form:Tablet;Dosage：250mg; multiple dose phase</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>XY0206</intervention_name>
    <description>Dosage form:Tablet;Multiple dose phase:Take the medicine once a day,1 tablet at a time.4 weeks of continuous medication is one course of treatment. After the first course of treatment, the subjects can continue to receive the experimental drug treatment until they meet the withdrawal criteria. The duration and interval of treatment were determined according to the accumulated condition after multiple dose.</description>
    <arm_group_label>XY0206-100mg</arm_group_label>
    <arm_group_label>XY0206-12.5mg</arm_group_label>
    <arm_group_label>XY0206-150mg</arm_group_label>
    <arm_group_label>XY0206-200mg</arm_group_label>
    <arm_group_label>XY0206-250mg</arm_group_label>
    <arm_group_label>XY0206-25mg</arm_group_label>
    <arm_group_label>XY0206-50mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must meet all of the following criteria before entering the group:&#xD;
&#xD;
             1. At least 18 years old; 2. Based on the World Health Organization (WHO) 2016&#xD;
             classification, the patients who were confirmed by the morphology of bone marrow cells&#xD;
             and met the diagnosis criteria of relapsed / refractory AML (refer to the Chinese&#xD;
             diagnosis and treatment guidelines for relapsed and refractory acute myeloid leukemia&#xD;
             (2017 version)), the diagnosis criteria of relapsed AML: after CR, the peripheral&#xD;
             blood once again showed leukemia cells or the original / immature cells in bone marrow&#xD;
             were more than 5% (except the bone marrow after consolidated chemotherapy) The&#xD;
             diagnosis standard of refractory AML: the primary refractory disease that has not been&#xD;
             completely relieved after two courses of chemotherapy induced by standard regimen&#xD;
             (including cytarabine and an anthracycline or anthraquinone drug); 3. ECOG physical&#xD;
             fitness score is ≤ 2 points ; 4 Estimated survival time ≥ 12 weeks; 5 The organ&#xD;
             function level of subjects must meet the following requirements:&#xD;
&#xD;
               -  Blood routine test: WBC ≤ 30 × 109 / L (it is allowed to take hydroxyurea until 3&#xD;
                  days before administration of test drug to stabilize WBC);&#xD;
&#xD;
               -  Blood biochemistry: serum creatinine (Scr) ≤ 1.5 × ULN or creatinine clearance&#xD;
                  rate (Ccr) ≥ 60 ml / min (using Cockcroft -Gault formula); alanine&#xD;
                  aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase&#xD;
                  (ALP) ≤ 2.5 × ULN (liver with leukemia cell infiltration ≤ 5 × ULN), total&#xD;
                  bilirubin (TBIL) ≤ 1.5 × ULN;&#xD;
&#xD;
               -  Electrolyte: the content of potassium, sodium, calcium and magnesium in the blood&#xD;
                  is within the normal value range of the laboratory (if the abnormal laboratory&#xD;
                  result judged by the researcher is of no clinical significance or can be&#xD;
                  controlled within the normal value range by drugs in the screening period, the&#xD;
                  subject can be included in the group);&#xD;
&#xD;
               -  Coagulation function: INR ≤ 1.5 × ULN, APTT &lt; 10 seconds, PT &lt; 3 seconds, FIB ≥&#xD;
                  1.5g/l (blood products or drugs are allowed to be corrected 3 days before&#xD;
                  administration of test drugs);&#xD;
&#xD;
               -  Friderica corrected QT value (QTC) for male ≤ 450 ms or female ≤ 470 MS;&#xD;
&#xD;
               -  LVEF≥ 50%；&#xD;
&#xD;
               -  Urinary protein &lt; 2 + was detected in urine routine. If urinary protein ≥ 2 +,&#xD;
                  24-hour urinary protein quantification is needed, and only when 24-hour urinary&#xD;
                  protein &lt; 2g can be enrolled in the group; 6. The serum pregnancy test must be&#xD;
                  carried out within 28 days before receiving the first dose of study drug and the&#xD;
                  result must be negative. The women of childbearing age and the male subjects&#xD;
                  agree to adopt the routine and effective contraceptive measures during the whole&#xD;
                  study period and within 6 months after the treatment; 7. The subjects should be&#xD;
                  willing to provide effective diagnosis evidence before treatment or accept bone&#xD;
                  marrow puncture or biopsy for diagnosis, and accept bone marrow puncture or&#xD;
                  biopsy for efficacy evaluation after treatment; 8. Volunteer to participate in&#xD;
                  clinical research and sign informed consent in writing.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients cannot participate in this clinical study if they meet any of the following&#xD;
             conditions:&#xD;
&#xD;
               1. Known allergy to the study drug or any of its ingredients; has been treated with&#xD;
                  sunitinib malate, or allergy to sunitinib malate;&#xD;
&#xD;
               2. BCR / ABL positive leukemia (chronic myeloid leukemia);&#xD;
&#xD;
               3. The subjects had central nervous system leukemia;&#xD;
&#xD;
               4. The subjects had secondary AML after chemotherapy for other tumors (except MDS);&#xD;
&#xD;
               5. At the same time, patients with other malignant tumors (except for those with&#xD;
                  cured stage IB or lower grade cervical cancer, non-invasive basal cell or&#xD;
                  squamous cell skin cancer, malignant melanoma with complete remission (CR) &gt; 10&#xD;
                  years, and other malignant tumors with complete remission (CR) &gt; 5 years);&#xD;
&#xD;
               6. Treatment before the trial:&#xD;
&#xD;
                    -  Previous treatment with FLT3 inhibitor;&#xD;
&#xD;
                    -  Patients who have received allogeneic hematopoietic stem cell&#xD;
                       transplantation before;&#xD;
&#xD;
                    -  Received chemotherapy, biotherapy, targeted antitumor therapy within 28 days&#xD;
                       before starting to use the study drug, and radiotherapy within 14 days;&#xD;
&#xD;
                    -  Drugs with significant effect on P450 metabolic enzyme pathway taken within&#xD;
                       2 weeks before the screening period;&#xD;
&#xD;
                    -  Have participated in other clinical studies and applied research drugs&#xD;
                       within 28 days before starting to use research drugs;&#xD;
&#xD;
                    -  Major surgery or significant traumatic injury within 28 days prior to the&#xD;
                       first administration of the study treatment or maybe major surgery is needed&#xD;
                       during the study treatment period;&#xD;
&#xD;
                    -  Concomitant drugs that may cause QTc prolongation or induce torsade de&#xD;
                       pointes (TdP) are required, in addition to antimicrobials used as standard&#xD;
                       therapy for the prevention or treatment of infection and other such drugs&#xD;
                       considered essential by the researchers;&#xD;
&#xD;
               7. The toxic and side effects caused by previous treatment did not recover to CTCAE&#xD;
                  ≤ 1, except for hair loss and other tolerable events judged by the researchers;&#xD;
&#xD;
               8. Combined diseases:&#xD;
&#xD;
                    -  One or more HBsAg, HCV, anti HIV or anti Treponema pallidum specific&#xD;
                       antibodies are positive;&#xD;
&#xD;
                    -  Clinically significant gastrointestinal abnormalities that may affect drug&#xD;
                       intake, transport or absorption (e.g., inability to swallow, chronic&#xD;
                       diarrhea, intestinal obstruction, peptic ulcer, etc.), subjects with total&#xD;
                       gastrectomy, or patients with malabsorption syndrome;&#xD;
&#xD;
                    -  Have a history of uncontrolled epilepsy, central nervous system disease or&#xD;
                       mental illness;&#xD;
&#xD;
                    -  Hypertension with poor drug control (persistent systolic blood pressure ≥&#xD;
                       150 mmHg and / or diastolic blood pressure ≥ 100 mmHg despite&#xD;
                       antihypertensive treatment);&#xD;
&#xD;
                    -  Poorly controlled diabetes mellitus (fasting blood glucose continues to be &gt;&#xD;
                       7.1mmol/L despite hypoglycemic treatment), or insulin-dependent diabetes&#xD;
                       mellitus (type I diabetes), or non insulin-dependent diabetes mellitus with&#xD;
                       small vessel disease, or pancreatic dysfunction;&#xD;
&#xD;
                    -  In the 12 months before the first application, there were any of the&#xD;
                       following conditions: symptomatic congestive heart failure (New York Heart&#xD;
                       Association class II-IV), uncontrolled arrhythmia, angina pectoris,&#xD;
                       myocardial infarction, stroke (except lacunar infarction), coronary /&#xD;
                       peripheral artery bypass surgery, pulmonary embolism;&#xD;
&#xD;
                    -  Long QT syndrome with congenital long QT interval syndrome or known family&#xD;
                       history;&#xD;
&#xD;
                    -  There is a history of LVEF falling below 40%;&#xD;
&#xD;
                    -  Uncontrolled active infections (bacteria, viruses, fungi, etc.);&#xD;
&#xD;
                    -  Bleeding grade ≥ grade 3 ;&#xD;
&#xD;
                    -  Have adrenal insufficiency;&#xD;
&#xD;
                    -  The thyroid function was abnormal in the past, or could not be maintained in&#xD;
                       the normal range even under the condition of drug treatment;&#xD;
&#xD;
                    -  Currently, there are serious unhealed wounds, ulcers or fractures;&#xD;
&#xD;
                    -  Stevens Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN);&#xD;
&#xD;
               9. For female subjects: currently in pregnancy or lactation;&#xD;
&#xD;
              10. Any previous or current disease, treatment, or laboratory abnormality that may&#xD;
                  interfere with the results of the study, affect the subject's participation in&#xD;
                  the whole process of the study, or the subject is not suitable for the study in&#xD;
                  the opinion of the investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Junyuan Qi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute of Hematology, Chinese Academy of Medical Sciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>wei Wang, master</last_name>
    <phone>086-0311-66703017</phone>
    <email>wangwei001@yiling.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jianxiang Wang, MD</last_name>
    <phone>022-23909120</phone>
    <email>wangjx@ihcams.ac.cn</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Institute of Hematology, Chinese Academy of Medical Sciences</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300052</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Junyuan Qi, MD</last_name>
      <phone>18622662361</phone>
      <email>qi_jy@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>May 17, 2023</last_update_submitted>
  <last_update_submitted_qc>May 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 18, 2023</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/NCT04471064
org study id: HY-XY0206-Ⅰ-02
nct id: NCT04471064
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
1. To evaluate the safety and tolerability of xy0206 as single drug in the treatment of
           relapsed / refractory AML;

        2. Evaluate the dose limited toxicity (DLT) and maximum tolerable dose (MTD) of xy0206 as
           single drug in the treatment of relapsed / refractory AML subjects.

        3. To evaluate the pharmacokinetic (PK), pharmacokinetic (PD) characteristics and PK / PD
           correlation of xy0206 as single drug treatment in relapsed / refractory AML subjects;

        4. To evaluate the primary efficacy of xy0206 as single drug in the treatment of relapsed /
           refractory AML patients;

        5. To evaluate biomarkers of xy0206 as single drug treatment for relapsed / refractory AML
           subjects.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum tolerable dose
time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
description: The occurrence of Maximum tolerable dose.
measure: Dose limiting toxicity
time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
description: The occurrence of Dose limiting toxicity.
measure: Adverse event
time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
description: The occurrence rate of Adverse event.
measure: Adverse drug reactions
time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
description: The occurrence rate of adverse drug reactions.
measure: Serious adverse events
time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
description: The occurrence rate of Serious adverse events.
measure: Blood routine
time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
description: Check whether the red blood cell system, white blood cell system and platelet system are normal
measure: Urine routine
time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
description: Urine routine examination includes urine color, transparency, pH, red blood cells, white blood cells, epithelial cells, tube type, protein, specific gravity and urine sugar.
measure: Stool routine
time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
description: Routine stool tests include the detection of red and white blood cells in feces, bacterial sensitivity test, occult blood test (OB) and inspection of eggs.
measure: Blood biochemistry
time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
description: The contents of various ions, sugars, lipids, proteins, enzymes, hormones and metabolites in blood were detected
measure: Serum amylase / lipase
time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
description: Evaluation of pancreatic function
measure: Coagulation function
time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
description: Four coagulation parameters including prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT) and fibrinogen (FIB) were evaluated.
measure: ECG
time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
description: Evaluation of QT interval
measure: Echocardiography
time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
description: To evaluate the electrophysiological condition of the heart
measure: Imaging examination
time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
description: Chest X-ray/CT
measure: Body temperature
time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
description: One of the vital signs.
measure: Blood pressure
time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
description: Assess whether systolic blood pressure and diastolic blood pressure are normal
measure: Heart rate
time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
description: One of the vital signs.
measure: Breathing
time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
description: Assess if breathing is normal
measure: Skin
time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
description: Assess if the skin is normal.
measure: Head
time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
description: Head examination includes head, eyes, ears, nose, lips, etc.Assess if head is normal
measure: Neck
time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
description: Neck examination includes thyroid gland, lymph node, etc.Assess if neck is normal.
measure: Chest
time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
description: Chest examination includes lung, cardiovascular, etc.Assess if chest is normal.
measure: Abdomen
time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
description: Abdominal examination includes liver and spleen.Assess if abdomen is normal.
measure: Limbs
time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
description: Assess if limbs is normal.
measure: Nerves
time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
description: Assess nerve function by communication
measure: Back/spine
time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
description: Assess if back/spine is normal.
arm group label: XY0206-12.5mg
arm group type: Experimental
description: Drug:XY0206;Dosage form:Tablet;Dosage：12.5mg; multiple dose phase
arm group label: XY0206-25mg
arm group type: Experimental
description: Drug:XY0206;Dosage form:Tablet;Dosage：25mg; multiple dose phase
arm group label: XY0206-50mg
arm group type: Experimental
description: Drug:XY0206;Dosage form:Tablet;Dosage：50mg; multiple dose phase
arm group label: XY0206-100mg
arm group type: Experimental
description: Drug:XY0206;Dosage form:Tablet;Dosage：100mg; multiple dose phase
arm group label: XY0206-150mg
arm group type: Experimental
description: Drug:XY0206;Dosage form:Tablet;Dosage：150mg; multiple dose phase
arm group label: XY0206-200mg
arm group type: Experimental
description: Drug:XY0206;Dosage form:Tablet;Dosage：200mg; multiple dose phase
arm group label: XY0206-250mg
arm group type: Experimental
description: Drug:XY0206;Dosage form:Tablet;Dosage：250mg; multiple dose phase
intervention type: Drug
intervention name: XY0206
description: Dosage form:Tablet;Multiple dose phase:Take the medicine once a day,1 tablet at a time.4 weeks of continuous medication is one course of treatment. After the first course of treatment, the subjects can continue to receive the experimental drug treatment until they meet the withdrawal criteria. The duration and interval of treatment were determined according to the accumulated condition after multiple dose.
arm group label: XY0206-100mg
arm group label: XY0206-12.5mg
arm group label: XY0206-150mg
arm group label: XY0206-200mg
arm group label: XY0206-250mg
arm group label: XY0206-25mg
arm group label: XY0206-50mg
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Junyuan Qi, MD
role: Principal Investigator
affiliation: Institute of Hematology, Chinese Academy of Medical Sciences
last name: wei Wang, master
phone: 086-0311-66703017
email: wangwei001@yiling.cn
last name: Jianxiang Wang, MD
phone: 022-23909120
email: wangjx@ihcams.ac.cn
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Leukemia, Myeloid
mesh term: Leukemia, Myeloid, Acute
sharing ipd: No