<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/NCT01720901</url>
  </required_header>
  <id_info>
    <org_study_id>BD-IC-IV41</org_study_id>
    <nct_id>NCT01720901</nct_id>
  </id_info>
  <brief_title>Increased Dose of Icotinib in Advanced None Small Cell Lung Cancer Patients After Routine Gefitinib Therapy</brief_title>
  <official_title>An Open, Single-Center,Single Arm Trial to Evaluate the Efficacy and Safety of Increased Dose of Icotinib in Advanced None Small Cell Lung Cancer Patients After Routine Gefitinib Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Betta Pharmaceuticals Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Betta Pharmaceuticals Co., Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the efficacy and safety of increased dose of icotinib in advanced NSCLC patients&#xD;
      who progressed after gefitinib therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This single center, single arm open label study is designed to assess the safety and efficacy&#xD;
      of using high dose of Icotinib (Conmana) as a way to treat patients with non-small cell lung&#xD;
      cancer that progressed after routine gefitinib therapy by progression-free survival, as well&#xD;
      as overall survival and disease control rate. The adverse events and adverse reaction are&#xD;
      evaluated as well.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    Accrual limitations&#xD;
  </why_stopped>
  <start_date>February 2013</start_date>
  <completion_date type="Anticipated">December 2016</completion_date>
  <primary_completion_date type="Anticipated">December 2015</primary_completion_date>
  <phase>Phase 4</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>Progression-free survival</measure>
    <time_frame>4.5 months</time_frame>
    <description>Progression-free survival is defined as a duration from the date that first dose is given to disease progression or death.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>12 months</time_frame>
    <description>Overall survival is a duration from the date that first dose is given to the date of death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tumor response</measure>
    <time_frame>6 weeks</time_frame>
    <description>Tumor response is designed by imaging according to Response Evaluation Criteria in Solid Tumors, including complete response, partial remission, stable disease as well as progressed disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>18 months</time_frame>
    <description>Adverse events will be coded in term of the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Non-small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Icotinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Icotinib will be administered 250 mg one time by month, 3 times per day.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Icotinib</intervention_name>
    <description>Icotinib will be administered 250 mg one time by month, 3 times per day.</description>
    <arm_group_label>Icotinib</arm_group_label>
    <other_name>Conmana</other_name>
    <other_name>BPI-2009</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically or cytologically confirmed local advanced or metastatic stage IIIB/IV&#xD;
             NSCLC.&#xD;
&#xD;
          -  Have been treated with gefitinib and achieved completed response, partial remission,&#xD;
             or stable disease within 3 months after first dose of gefitinib.&#xD;
&#xD;
          -  At least one measurable lesion according to Response Evaluation Criteria in Solid&#xD;
             Tumors.&#xD;
&#xD;
          -  Signed and dated informed consent before the start of specific protocol procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergic to icotinib.&#xD;
&#xD;
          -  Gefitinib excepted, experience of Anti-tumor Monoclonal Antibody or small molecular&#xD;
             compounds therapy such as erlotinib or Cetuximab.&#xD;
&#xD;
          -  Severe systemic disease out of control such as unstable or uncompensated&#xD;
             respiratory,cardiac,liver,renal diseases.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hu Chengping, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Xiangya Hospital, Central-South Univercity</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Xiangya Hospital, Central-South Univercity</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410008</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>October 31, 2012</study_first_submitted>
  <study_first_submitted_qc>October 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 2, 2012</study_first_posted>
  <last_update_submitted>May 21, 2015</last_update_submitted>
  <last_update_submitted_qc>May 21, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 22, 2015</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>Small Cell Lung Carcinoma</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/NCT01720901
org study id: BD-IC-IV41
nct id: NCT01720901
lead sponsor: 
has dmc: Yes
To evaluate the efficacy and safety of increased dose of icotinib in advanced NSCLC patients
      who progressed after gefitinib therapy.
This single center, single arm open label study is designed to assess the safety and efficacy
      of using high dose of Icotinib (Conmana) as a way to treat patients with non-small cell lung
      cancer that progressed after routine gefitinib therapy by progression-free survival, as well
      as overall survival and disease control rate. The adverse events and adverse reaction are
      evaluated as well.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression-free survival
time frame: 4.5 months
description: Progression-free survival is defined as a duration from the date that first dose is given to disease progression or death.
measure: Overall survival
time frame: 12 months
description: Overall survival is a duration from the date that first dose is given to the date of death.
measure: Tumor response
time frame: 6 weeks
description: Tumor response is designed by imaging according to Response Evaluation Criteria in Solid Tumors, including complete response, partial remission, stable disease as well as progressed disease.
measure: Adverse Events
time frame: 18 months
description: Adverse events will be coded in term of the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events.
arm group label: Icotinib
arm group type: Experimental
description: Icotinib will be administered 250 mg one time by month, 3 times per day.
intervention type: Drug
intervention name: Icotinib
description: Icotinib will be administered 250 mg one time by month, 3 times per day.
arm group label: Icotinib
other name: Conmana
other name: BPI-2009
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Hu Chengping, M.D.
role: Principal Investigator
affiliation: Xiangya Hospital, Central-South Univercity
facility: 
country: China
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Small Cell Lung Carcinoma