<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/NCT03264794</url>
  </required_header>
  <id_info>
    <org_study_id>CTTQ-20161017</org_study_id>
    <nct_id>NCT03264794</nct_id>
  </id_info>
  <brief_title>the Clinical Trial of Gefitinib(Non - Small Cell Lung Cancer)</brief_title>
  <official_title>Evaluation of the Efficacy of Domestic Gefitinib Tablets in the Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer Patients Using a Multicenter, Randomized, Positive Drug Gefitinib Pharmacodynamics and Pharmacodynamics</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jiangsu Famous Medical Technology Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jiangsu Famous Medical Technology 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. Gefitinib CTTQ production gefitinib and erlotinib sheet AstraZeneca imatinib sheet&#xD;
           (trade name: Iressa ®) comparison, human pharmacokinetics and relative bioavailability&#xD;
           of comparative studies which examine people in vivo pharmacokinetic behavior, provide&#xD;
           the basis for clinical use.&#xD;
&#xD;
        2. Evaluation CTTQ gefitinib imatinib sheet production efficacy and safety of Chinese&#xD;
           patients with locally advanced or metastatic non-small cell lung cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 2017</start_date>
  <completion_date type="Anticipated">June 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2021</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Gefitinib plasma concentration</measure>
    <time_frame>0hour before administration and 1, 2, 3, 4, 5, 6, 7, 8,9,13,24,48,72,120,168 16 hour time points after administration</time_frame>
    <description>After the use of gefitinib to reach the highest plasma concentration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tmax time</measure>
    <time_frame>0hour before administration and 1, 2, 3, 4, 5, 6, 7, 8,9,13,24,48,72,120,168 16 hour time points after administration</time_frame>
    <description>Taking the time required for the concentration of gefitinib to reach the peak</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC0-t</measure>
    <time_frame>0hour before administration and 1, 2, 3, 4, 5, 6, 7, 8,9,13,24,48,72,120,168 16 hour time points after administration</time_frame>
    <description>The area between the axis of the coordinate and the time drug concentration curve</description>
  </primary_outcome>
  <primary_outcome>
    <measure>t 1/2</measure>
    <time_frame>0hour before administration and 1, 2, 3, 4, 5, 6, 7, 8,9,13,24,48,72,120,168 16 hour time points after administration</time_frame>
    <description>The time required for gefitinib to decrease by half the highest concentration in plasma</description>
  </primary_outcome>
  <primary_outcome>
    <measure>F</measure>
    <time_frame>0hour before administration and 1, 2, 3, 4, 5, 6, 7, 8,9,13,24,48,72,120,168 16 hour time points after administration</time_frame>
    <description>Gefitinib absorbs the relative amount of blood into the cycle</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Non-small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>trial group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Gefitinib tablets (CTTQ），First medication.From the 8th day of the experiment, treated with Gefitinib Tab（CTTQ）</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Gefitinib tablets (Yi Ruisha），First medication.From the 8th day of the experiment, treated with Gefitinib Tab（CTTQ）</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gefitinib Tab （CTTQ），First medication；Gefitinib Tab （CTTQ），From the 8th day of trial</intervention_name>
    <description>Gefitinib Tab （CTTQ），First medication,250mg；</description>
    <arm_group_label>trial group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gefitinib tablets (Yi Ruisha），First medication</intervention_name>
    <description>Gefitinib tablets (Yi Ruisha），First medication,250mg；</description>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gefitinib Tab 250 MG（CTTQ），From the 8th day of trial.</intervention_name>
    <description>From the 8th day of the experiment, two groups of subjects were treated with Gefitinib（CTTQ）</description>
    <arm_group_label>control group</arm_group_label>
    <arm_group_label>trial group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients volunteered to participate in this study, signed informed consent;&#xD;
&#xD;
          2. ≥18 years old; ECOG PS score: 0 ~ 1; expected survival period of more than 3 months;&#xD;
&#xD;
          3. patients with locally advanced or metastatic non-small cell lung cancer diagnosed by&#xD;
             histology or cytology, who can not receive radical surgery or radiotherapy; patients&#xD;
             with measurable lesions(according to RECIST criteria);&#xD;
&#xD;
          4. Detection of EGFR-positive exon 19 deletion or exon 21 (L858R) mutation was performed&#xD;
             by providing a detectable specimen (tissue or cancerous pleural effusion) prior to&#xD;
             enrollment;&#xD;
&#xD;
          5. The main organ function within 7 days before treatment, meet the following criteria:&#xD;
&#xD;
        (1) blood routine examination criteria (14 days without blood transfusion): A) hemoglobin≥&#xD;
        90g / L; B) neutrophil absolute ≥ 1.5 × 109 / L; C) platelet ≥80 × 109 / L (2) biochemical&#xD;
        tests to meet the following criteria: A) total bilirubin ≤ 1.5 times the upper limit of&#xD;
        normal (ULN); B) alanine aminotransferase and aspartate aminotransferase AST ≤ 2.5ULN, such&#xD;
        as liver metastasis, ALT and AST ≤ 5ULN; C) serum creatinine ≤ 1.5ULN or creatinine&#xD;
        clearance ≥ 60ml / min; (3) Doppler ultrasound evaluation: left ventricular ejection&#xD;
        fraction (LVEF) ≥ normal low (50%).&#xD;
&#xD;
        6.Women of childbearing age should agree that contraceptive measures (such as intrauterine&#xD;
        devices, birth control pills or condoms) must be used within the study period and within 6&#xD;
        months after the end of the study; serum or urine pregnancy test is negative within 7 days&#xD;
        prior to enrollment, And must be non-lactating patients; men should agree to patients who&#xD;
        have contraceptive use during the study period and six months after the end of the study&#xD;
        period.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. patients who have previously used EGFR-TKI drugs;&#xD;
&#xD;
          2. small cell lung cancer (including small cell carcinoma and non-small cell carcinoma&#xD;
             mixed lung cancer);&#xD;
&#xD;
          3. central type, with empty lung squamous cell carcinoma, or with non-small cell lung&#xD;
             cancer with hemoptysis (&gt; 50 ml / day) 4.5 years or at the same time with other&#xD;
             malignancies, cured cervical carcinoma in situ, non-melanoma skin cancer and&#xD;
             superficial bladder tumor except [Ta (non-invasive tumor), Tis (carcinoma in situ )&#xD;
             And T1 (tumor infiltrating basement membrane)];&#xD;
&#xD;
        5.Whole-body antitumor therapy was planned within 4 weeks prior to randomization or during&#xD;
        the course of this study, including cytotoxic therapy, signal transduction inhibitors,&#xD;
        immunotherapy (or use of mitogen at 6 weeks prior to administration of the test drug) C);&#xD;
        6.patients with symptomatic or unstable brain metastases; 7.patients with any severe and /&#xD;
        or uncontrolled disease, including: A) cirrhosis, acute or active hepatitis; B) history of&#xD;
        immunodeficiency, including HIV-positive or other acquired, congenital immunodeficiency&#xD;
        disease, or history of organ transplantation; C) patients with seizures and who need&#xD;
        treatment; 8.active or uncontrollable serious infection (≥CTC AE Level 2 infection); 9.with&#xD;
        a history of mental illness and can not quit or have mental disorders; 10.participated in&#xD;
        other anti-tumor drug clinical trials within four weeks; 11.According to the judge's&#xD;
        judgment, there is an impact on the absorption of oral drugs or serious harm to the safety&#xD;
        of patients is not suitable for participation in the study of the situation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>July 3, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>August 28, 2017</last_update_submitted>
  <last_update_submitted_qc>August 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2017</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>Lung Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gefitinib</mesh_term>
  </intervention_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/NCT03264794
org study id: CTTQ-20161017
nct id: NCT03264794
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
1. Gefitinib CTTQ production gefitinib and erlotinib sheet AstraZeneca imatinib sheet
           (trade name: Iressa ®) comparison, human pharmacokinetics and relative bioavailability
           of comparative studies which examine people in vivo pharmacokinetic behavior, provide
           the basis for clinical use.

        2. Evaluation CTTQ gefitinib imatinib sheet production efficacy and safety of Chinese
           patients with locally advanced or metastatic non-small cell lung cancer.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Gefitinib plasma concentration
time frame: 0hour before administration and 1, 2, 3, 4, 5, 6, 7, 8,9,13,24,48,72,120,168 16 hour time points after administration
description: After the use of gefitinib to reach the highest plasma concentration
measure: Tmax time
time frame: 0hour before administration and 1, 2, 3, 4, 5, 6, 7, 8,9,13,24,48,72,120,168 16 hour time points after administration
description: Taking the time required for the concentration of gefitinib to reach the peak
measure: AUC0-t
time frame: 0hour before administration and 1, 2, 3, 4, 5, 6, 7, 8,9,13,24,48,72,120,168 16 hour time points after administration
description: The area between the axis of the coordinate and the time drug concentration curve
measure: t 1/2
time frame: 0hour before administration and 1, 2, 3, 4, 5, 6, 7, 8,9,13,24,48,72,120,168 16 hour time points after administration
description: The time required for gefitinib to decrease by half the highest concentration in plasma
measure: F
time frame: 0hour before administration and 1, 2, 3, 4, 5, 6, 7, 8,9,13,24,48,72,120,168 16 hour time points after administration
description: Gefitinib absorbs the relative amount of blood into the cycle
arm group label: trial group
arm group type: Experimental
description: Gefitinib tablets (CTTQ），First medication.From the 8th day of the experiment, treated with Gefitinib Tab（CTTQ）
arm group label: control group
arm group type: Active Comparator
description: Gefitinib tablets (Yi Ruisha），First medication.From the 8th day of the experiment, treated with Gefitinib Tab（CTTQ）
intervention type: Drug
intervention name: Gefitinib Tab （CTTQ），First medication；Gefitinib Tab （CTTQ），From the 8th day of trial
description: Gefitinib Tab （CTTQ），First medication,250mg；
arm group label: trial group
intervention type: Drug
intervention name: Gefitinib tablets (Yi Ruisha），First medication
description: Gefitinib tablets (Yi Ruisha），First medication,250mg；
arm group label: control group
intervention type: Drug
intervention name: Gefitinib Tab 250 MG（CTTQ），From the 8th day of trial.
description: From the 8th day of the experiment, two groups of subjects were treated with Gefitinib（CTTQ）
arm group label: control group
arm group label: trial group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Gefitinib
sharing ipd: Undecided