<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/NCT02996838</url>
  </required_header>
  <id_info>
    <org_study_id>TQ-B3234-I-0001</org_study_id>
    <nct_id>NCT02996838</nct_id>
  </id_info>
  <brief_title>A Phase I Study of TQ-B3234 on Tolerance and Pharmacokinetics</brief_title>
  <official_title>Phase I Study of Tolerance and Pharmacokinetics of TQ-B3234 in Patients With Advanced Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chia Tai Tianqing Pharmaceutical Group Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chia Tai Tianqing Pharmaceutical Group 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>
      To study the pharmacokinetic characteristics of TQ-B3234 in the human body, recommend a&#xD;
      reasonable regimen for subsequent research.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 11, 2017</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2020</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>The maximum tolerated dose (MTD) of TQ-B3234</measure>
    <time_frame>48 weeks</time_frame>
    <description>Yes ]The highest dose at which no more than 33% of the subjects experience a dose-limiting toxicity (DLT) during treatment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The type of dose-limiting toxicity(ies) (DLT[s]) of TQ-B3234</measure>
    <time_frame>For 4 weeks for DLTs</time_frame>
    <description>Subjects within 28 days after treatment appear the following toxicity reaction relate to the drug ：III °or above of non-hematological toxicity,IV°hematological toxicity ,Neutropenia associated with fever</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics of TQ-B3234 (in whole blood):Peak Plasma Concentration(Cmax)</measure>
    <time_frame>up to 28 Days (endpoint when the two consecutive time points of blood drug concentration &lt;150 DPM/mL)</time_frame>
    <description>Peak Plasma Concentration(Cmax),Cmax in ng/mL.In the study of single-dose, full PK profiles will be obtained at H0/H0.5/H1/H2/H3/H4/H6/H10/H24/H34/H48/H72/H96/H120/H144（H means Hour）.In the study of multiple-dose,full PK profiles will be obtained at D1/D4/D8/D15/D21/D22/D23/D25/D28（D means Day）</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics of TQ-B3234 (in whole blood):Peak time（Tmax）</measure>
    <time_frame>up to 28 Days (endpoint when the two consecutive time points of blood drug concentration &lt;150 DPM/mL)</time_frame>
    <description>Peak time（Tmax）,Tmax in h.In the study of single-dose, full PK profiles will be obtained at H0/H0.5/H1/H2/H3/H4/H6/H10/H24/H34/H48/H72/H96/H120/H144（H means Hour）.In the study of multiple-dose,full PK profiles will be obtained at D1/D4/D8/D15/D21/D22/D23/D25/D28（D means Day）</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics of TQ-B3234 (in whole blood):Half life（t1/2）</measure>
    <time_frame>up to 28 Days (endpoint when the two consecutive time points of blood drug concentration &lt;150 DPM/mL)</time_frame>
    <description>Half life（t1/2）,t1/2 in h.In the study of single-dose, full PK profiles will be obtained at H0/H0.5/H1/H2/H3/H4/H6/H10/H24/H34/H48/H72/H96/H120/H144（H means Hour）.In the study of multiple-dose,full PK profiles will be obtained at D1/D4/D8/D15/D21/D22/D23/D25/D28（D means Day）</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics of TQ-B3234 (in whole blood):Area under the plasma concentration versus time curve (AUC)</measure>
    <time_frame>up to 28 Days (endpoint when the two consecutive time points of blood drug concentration &lt;150 DPM/mL)</time_frame>
    <description>Area under the plasma concentration versus time curve (AUC), AUC in ng.h/mL.In the study of single-dose,full PK profiles will be obtained at H0/H0.5/H1/H2/H3/H4/H6/H10/H24/H34/H48/H72/H96/H120/H144（H means Hour）.In the study of multiple-dose,full PK profiles will be obtained at D1/D4/D8/D15/D21/D22/D23/D25/D28（D means Day）</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics of TQ-B3234 (in whole blood):Clearance（CL）</measure>
    <time_frame>up to 28 Days (endpoint when the two consecutive time points of blood drug concentration &lt;150 DPM/mL)</time_frame>
    <description>Clearance（CL）,CL in L/h.In the study of single-dose,full PK profiles will be obtained at H0/H0.5/H1/H2/H3/H4/H6/H10/H24/H34/H48/H72/H96/H120/H144（H means Hour）.In the study of multiple-dose,full PK profiles will be obtained at D1/D4/D8/D15/D21/D22/D23/D25/D28（D means Day）</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate (ORR)</measure>
    <time_frame>each 56 days up to intolerance the toxicity or PD (up to 24 months)</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Advanced Cancer</condition>
  <arm_group>
    <arm_group_label>TQ-B3234</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TQ-B3234 QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TQ-B3234</intervention_name>
    <description>TQ-B3234 p.o. qd</description>
    <arm_group_label>TQ-B3234</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histological documentation of Advanced solid tumors,such as Malignant&#xD;
             Melanoma,Colorectal Cancer,Pancreatic Carcinoma,Thyroid Carcinoma&#xD;
&#xD;
          -  Lack of the standard treatment or treatment failure&#xD;
&#xD;
          -  18-65 years,ECOG PS:0-1,Life expectancy of more than 3 months&#xD;
&#xD;
          -  Main organs function is normal&#xD;
&#xD;
          -  Stop other previous chemotherapy drugs more than 4 weeks&#xD;
&#xD;
          -  Women of childbearing potential should agree to use and utilize an adequate method of&#xD;
             contraception (such as intrauterine device，contraceptive and condom) throughout&#xD;
             treatment and for at least 6 months after study is stopped；the result of serum or&#xD;
             urine pregnancy test should be negative within 7 days prior to study enrollment，and&#xD;
             the patients required to be non-lactating；Man participants should agree to use and&#xD;
             utilize an adequate method of contraception throughout treatment and for at least 6&#xD;
             months after study is stopped&#xD;
&#xD;
          -  Patients should participate in the study voluntarily and sign informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients participated in other anticancer drug clinical trials within 4 weeks or&#xD;
             Patients participating in other clinical trials now&#xD;
&#xD;
          -  Blood pressure unable to be controlled(systolic pressure&gt;140 mmHg，diastolic&#xD;
             pressure&gt;90 mmHg). Patients with Grade 1 or higher myocardial ischemia, myocardial&#xD;
             infarction or malignant arrhythmias(including QTc≥440ms)&#xD;
&#xD;
          -  Patients with non-healing wounds or fractures&#xD;
&#xD;
          -  Patients with drug abuse history and unable to get rid of or Patients with mental&#xD;
             disorders&#xD;
&#xD;
          -  History of immunodeficiency&#xD;
&#xD;
          -  Patients with concomitant diseases which could seriously endanger their own safety or&#xD;
             could affect completion of the study according to investigators' judgment&#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_contact>
    <last_name>Xiubao Ren, doctor</last_name>
    <phone>022-23340123</phone>
    <email>rwziyi@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Zhao Yan, pharmacist</last_name>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Tianjin Medical University Cancer Institute and Hospital</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300060</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiubao Ren, doctor</last_name>
    </contact>
    <contact_backup>
      <last_name>Zhao Yan, pharmacist</last_name>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>May 20, 2019</last_update_submitted>
  <last_update_submitted_qc>May 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 21, 2019</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>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02996838
org study id: TQ-B3234-I-0001
nct id: NCT02996838
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To study the pharmacokinetic characteristics of TQ-B3234 in the human body, recommend a
      reasonable regimen for subsequent research.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The maximum tolerated dose (MTD) of TQ-B3234
time frame: 48 weeks
description: Yes ]The highest dose at which no more than 33% of the subjects experience a dose-limiting toxicity (DLT) during treatment
measure: The type of dose-limiting toxicity(ies) (DLT[s]) of TQ-B3234
time frame: For 4 weeks for DLTs
description: Subjects within 28 days after treatment appear the following toxicity reaction relate to the drug ：III °or above of non-hematological toxicity,IV°hematological toxicity ,Neutropenia associated with fever
measure: Pharmacokinetics of TQ-B3234 (in whole blood):Peak Plasma Concentration(Cmax)
time frame: up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
description: Peak Plasma Concentration(Cmax),Cmax in ng/mL.In the study of single-dose, full PK profiles will be obtained at H0/H0.5/H1/H2/H3/H4/H6/H10/H24/H34/H48/H72/H96/H120/H144（H means Hour）.In the study of multiple-dose,full PK profiles will be obtained at D1/D4/D8/D15/D21/D22/D23/D25/D28（D means Day）
measure: Pharmacokinetics of TQ-B3234 (in whole blood):Peak time（Tmax）
time frame: up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
description: Peak time（Tmax）,Tmax in h.In the study of single-dose, full PK profiles will be obtained at H0/H0.5/H1/H2/H3/H4/H6/H10/H24/H34/H48/H72/H96/H120/H144（H means Hour）.In the study of multiple-dose,full PK profiles will be obtained at D1/D4/D8/D15/D21/D22/D23/D25/D28（D means Day）
measure: Pharmacokinetics of TQ-B3234 (in whole blood):Half life（t1/2）
time frame: up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
description: Half life（t1/2）,t1/2 in h.In the study of single-dose, full PK profiles will be obtained at H0/H0.5/H1/H2/H3/H4/H6/H10/H24/H34/H48/H72/H96/H120/H144（H means Hour）.In the study of multiple-dose,full PK profiles will be obtained at D1/D4/D8/D15/D21/D22/D23/D25/D28（D means Day）
measure: Pharmacokinetics of TQ-B3234 (in whole blood):Area under the plasma concentration versus time curve (AUC)
time frame: up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
description: Area under the plasma concentration versus time curve (AUC), AUC in ng.h/mL.In the study of single-dose,full PK profiles will be obtained at H0/H0.5/H1/H2/H3/H4/H6/H10/H24/H34/H48/H72/H96/H120/H144（H means Hour）.In the study of multiple-dose,full PK profiles will be obtained at D1/D4/D8/D15/D21/D22/D23/D25/D28（D means Day）
measure: Pharmacokinetics of TQ-B3234 (in whole blood):Clearance（CL）
time frame: up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
description: Clearance（CL）,CL in L/h.In the study of single-dose,full PK profiles will be obtained at H0/H0.5/H1/H2/H3/H4/H6/H10/H24/H34/H48/H72/H96/H120/H144（H means Hour）.In the study of multiple-dose,full PK profiles will be obtained at D1/D4/D8/D15/D21/D22/D23/D25/D28（D means Day）
measure: Objective Response Rate (ORR)
time frame: each 56 days up to intolerance the toxicity or PD (up to 24 months)
arm group label: TQ-B3234
arm group type: Experimental
description: TQ-B3234 QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
intervention type: Drug
intervention name: TQ-B3234
description: TQ-B3234 p.o. qd
arm group label: TQ-B3234
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Xiubao Ren, doctor
phone: 022-23340123
email: rwziyi@yahoo.com
last name: Zhao Yan, pharmacist
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Sponsor
mesh term: Neoplasms
sharing ipd: Undecided