<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/NCT01717482</url>
  </required_header>
  <id_info>
    <org_study_id>12-006865</org_study_id>
    <nct_id>NCT01717482</nct_id>
  </id_info>
  <brief_title>Metformin as a Chemoprevention Agent in Non-small Cell Lung Cancer</brief_title>
  <official_title>A Pilot Study of Metformin as a Chemoprevention Agent in Non-small Cell Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Alliance for Clinical Trials in Oncology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to learn whether it is better to receive the drug Metformin with&#xD;
      standard of care for lung cancer or just standard of care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will need to be scheduled to undergo a surgical resection of their lung cancer&#xD;
      at the Mayo Clinic in Rochester, Minnesota. They will be asked to provide a blood sample&#xD;
      prior to their surgery. Samples of tumor tissue and normal lung tissue will be taken from the&#xD;
      samples removed during your lung surgery. The tissue will be used to evaluate DNA. A skin&#xD;
      biopsy at the edge of the incision that has already been made will be done during your&#xD;
      surgery. We will take the skin and grow skin fibroblasts. Then we will reprogram the skin&#xD;
      fibroblasts into induced pluripotent cells. You will be &quot;randomized&quot; into one of the study&#xD;
      groups to either take Metformin for 6 months with your standard of care follow up or to&#xD;
      receive standard of care follow up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Poor accrual and funding ended&#xD;
  </why_stopped>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">May 22, 2019</completion_date>
  <primary_completion_date type="Actual">May 22, 2019</primary_completion_date>
  <phase>Phase 2</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate Feasibility of Patient Randomization, Accrual, and Tissue Collection for Study Conduction</measure>
    <time_frame>2 years</time_frame>
    <description>To evaluate the feasibility of patient randomization, accrual, and tissue collection in a pilot study of metformin versus observation following resection of stage IA-IIIA lung squamous cell cancer for patients by assessing the reasons patients decline randomization, tracking accrual numbers, and tracking collected tissue and reasons why tissue was not collected.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With 2-year Recurrence Free Survival</measure>
    <time_frame>4 years</time_frame>
    <description>To compare the 2-year recurrence free survival (RFS) rate between metformin and observation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measure Metformin Sensitivity in Induced Pluripotent Stem Cells (iPS)</measure>
    <time_frame>4 years</time_frame>
    <description>To develop the metformin sensitivity index based on iPS cell line metformin sensitivity measurements from the first 20 patients randomized to the metformin arm. We will then To apply the metformin sensitivity index on the remaining 25 patients randomized to metformin and the 45 observation patients (70 patients total) to compare the 2-year RFS rate between metformin-sensitive and metformin-not-sensitive patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events as a Measure of Safety</measure>
    <time_frame>4 years</time_frame>
    <description>To compare participant adverse events between metformin and observation arms using CTCAE version 4.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Lung Neoplasms</condition>
  <condition>Carcinoma, Non-Small-Cell Lung</condition>
  <arm_group>
    <arm_group_label>Metformin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Metformin 850mg twice a day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Observation</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Standard of Care Observation</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metformin</intervention_name>
    <arm_group_label>Metformin</arm_group_label>
    <other_name>Glucophage</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo Comparator</intervention_name>
    <description>Standard of Care Observation</description>
    <arm_group_label>Observation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Suspected or biopsy proven Stage IA-IIIA lung squamous cell carcinoma (SCC) (must be&#xD;
             proven SCC at the time of surgery)&#xD;
&#xD;
          -  Medically fit for surgical resection (based on surgeon assessment)&#xD;
&#xD;
          -  Current or prior smoker&#xD;
&#xD;
          -  Age &gt; 18 years old&#xD;
&#xD;
          -  Both Male and Female&#xD;
&#xD;
          -  Willing and able to consent to study, undergo study interventions, and take study drug&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2&#xD;
&#xD;
          -  Subject must start Metformin within 90 days of surgery.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Currently taking metformin or other diabetic drugs&#xD;
&#xD;
          -  Current or previous congestive heart failure, renal failure or liver failure&#xD;
&#xD;
          -  Creatinine in Women of 1.4 or greater and Creatinine in Men of 1.5 or greater&#xD;
&#xD;
          -  Existing untreated or prior cancer &lt;5 years from diagnosis&#xD;
&#xD;
          -  Received neo-adjuvant platinum-based chemotherapy or targeted therapy&#xD;
&#xD;
          -  Receiving adjuvant platinum-based chemotherapy or targeted therapy after surgical&#xD;
             resection&#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>Dennis Wigle, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>October 25, 2012</study_first_submitted>
  <study_first_submitted_qc>October 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <results_first_submitted>May 28, 2019</results_first_submitted>
  <results_first_submitted_qc>May 28, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">June 19, 2019</results_first_posted>
  <last_update_submitted>March 2, 2020</last_update_submitted>
  <last_update_submitted_qc>March 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Dennis Wigle</investigator_full_name>
    <investigator_title>M.D., P.h.D.</investigator_title>
  </responsible_party>
  <keyword>Bronchoscopy</keyword>
  <keyword>Metformin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
    <mesh_term>Lung Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metformin</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 10, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/82/NCT01717482/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Metformin</title>
          <description>Metformin 850mg twice per day&#xD;
Metformin</description>
        </group>
        <group group_id="P2">
          <title>Observation</title>
          <description>Standard of Care Observation&#xD;
Placebo Comparator: Standard of Care Observation</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Metformin</title>
          <description>Metformin 850mg twice per day&#xD;
Metformin</description>
        </group>
        <group group_id="B2">
          <title>Observation</title>
          <description>Standard of Care Observation&#xD;
Placebo Comparator: Standard of Care Observation</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="4"/>
            <count group_id="B2" value="2"/>
            <count group_id="B3" value="6"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63.25" spread="6.87"/>
                    <measurement group_id="B2" value="62.5" spread="7.5"/>
                    <measurement group_id="B3" value="63" spread="7.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Evaluate Feasibility of Patient Randomization, Accrual, and Tissue Collection for Study Conduction</title>
        <description>To evaluate the feasibility of patient randomization, accrual, and tissue collection in a pilot study of metformin versus observation following resection of stage IA-IIIA lung squamous cell cancer for patients by assessing the reasons patients decline randomization, tracking accrual numbers, and tracking collected tissue and reasons why tissue was not collected.</description>
        <time_frame>2 years</time_frame>
        <population>Study terminated due to poor accrual and funding ended</population>
        <group_list>
          <group group_id="O1">
            <title>Metformin</title>
            <description>Metformin 850mg twice per day&#xD;
Metformin</description>
          </group>
          <group group_id="O2">
            <title>Observation</title>
            <description>Standard of Care Observation&#xD;
Placebo Comparator: Standard of Care Observation</description>
          </group>
        </group_list>
        <measure>
          <title>Evaluate Feasibility of Patient Randomization, Accrual, and Tissue Collection for Study Conduction</title>
          <description>To evaluate the feasibility of patient randomization, accrual, and tissue collection in a pilot study of metformin versus observation following resection of stage IA-IIIA lung squamous cell cancer for patients by assessing the reasons patients decline randomization, tracking accrual numbers, and tracking collected tissue and reasons why tissue was not collected.</description>
          <population>Study terminated due to poor accrual and funding ended</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With 2-year Recurrence Free Survival</title>
        <description>To compare the 2-year recurrence free survival (RFS) rate between metformin and observation.</description>
        <time_frame>4 years</time_frame>
        <population>Study terminated due to poor accrual and funding ended</population>
        <group_list>
          <group group_id="O1">
            <title>Metformin</title>
            <description>Metformin 850mg twice a day&#xD;
Metformin</description>
          </group>
          <group group_id="O2">
            <title>Observation</title>
            <description>Standard of Care Observation&#xD;
Placebo Comparator: Standard of Care Observation</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With 2-year Recurrence Free Survival</title>
          <description>To compare the 2-year recurrence free survival (RFS) rate between metformin and observation.</description>
          <population>Study terminated due to poor accrual and funding ended</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Measure Metformin Sensitivity in Induced Pluripotent Stem Cells (iPS)</title>
        <description>To develop the metformin sensitivity index based on iPS cell line metformin sensitivity measurements from the first 20 patients randomized to the metformin arm. We will then To apply the metformin sensitivity index on the remaining 25 patients randomized to metformin and the 45 observation patients (70 patients total) to compare the 2-year RFS rate between metformin-sensitive and metformin-not-sensitive patients.</description>
        <time_frame>4 years</time_frame>
        <population>Study terminated due to poor accrual and funding ended</population>
        <group_list>
          <group group_id="O1">
            <title>Metformin</title>
            <description>Metformin 850mg twice per day&#xD;
Metformin</description>
          </group>
          <group group_id="O2">
            <title>Observation</title>
            <description>Standard of Care Observation&#xD;
Placebo Comparator: Standard of Care Observation</description>
          </group>
        </group_list>
        <measure>
          <title>Measure Metformin Sensitivity in Induced Pluripotent Stem Cells (iPS)</title>
          <description>To develop the metformin sensitivity index based on iPS cell line metformin sensitivity measurements from the first 20 patients randomized to the metformin arm. We will then To apply the metformin sensitivity index on the remaining 25 patients randomized to metformin and the 45 observation patients (70 patients total) to compare the 2-year RFS rate between metformin-sensitive and metformin-not-sensitive patients.</description>
          <population>Study terminated due to poor accrual and funding ended</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Adverse Events as a Measure of Safety</title>
        <description>To compare participant adverse events between metformin and observation arms using CTCAE version 4.</description>
        <time_frame>4 years</time_frame>
        <population>Study terminated due to poor accrual and funding ended</population>
        <group_list>
          <group group_id="O1">
            <title>Metformin</title>
            <description>Metformin 850mg twice per day&#xD;
Metformin</description>
          </group>
          <group group_id="O2">
            <title>Observation</title>
            <description>Standard of Care Observation&#xD;
Placebo Comparator: Standard of Care Observation</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events as a Measure of Safety</title>
          <description>To compare participant adverse events between metformin and observation arms using CTCAE version 4.</description>
          <population>Study terminated due to poor accrual and funding ended</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse Events were collected over a 24 months time period</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Metformin</title>
          <description>Metformin 850mg twice per day&#xD;
Metformin</description>
        </group>
        <group group_id="E2">
          <title>Observation</title>
          <description>Standard of Care Observation&#xD;
Placebo Comparator: Standard of Care Observation</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Bloating</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Stomach pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pleual Effusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Study terminated due to poor accrual and funding ended</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dennis Wigle, M.D., Ph.D.</name_or_title>
      <organization>Mayo Clinic</organization>
      <phone>507-284-8462</phone>
      <email>Wigle.Dennis@mayo.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01717482
org study id: 12-006865
nct id: NCT01717482
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to learn whether it is better to receive the drug Metformin with
      standard of care for lung cancer or just standard of care.
Participants will need to be scheduled to undergo a surgical resection of their lung cancer
      at the Mayo Clinic in Rochester, Minnesota. They will be asked to provide a blood sample
      prior to their surgery. Samples of tumor tissue and normal lung tissue will be taken from the
      samples removed during your lung surgery. The tissue will be used to evaluate DNA. A skin
      biopsy at the edge of the incision that has already been made will be done during your
      surgery. We will take the skin and grow skin fibroblasts. Then we will reprogram the skin
      fibroblasts into induced pluripotent cells. You will be "randomized" into one of the study
      groups to either take Metformin for 6 months with your standard of care follow up or to
      receive standard of care follow up.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Evaluate Feasibility of Patient Randomization, Accrual, and Tissue Collection for Study Conduction
time frame: 2 years
description: To evaluate the feasibility of patient randomization, accrual, and tissue collection in a pilot study of metformin versus observation following resection of stage IA-IIIA lung squamous cell cancer for patients by assessing the reasons patients decline randomization, tracking accrual numbers, and tracking collected tissue and reasons why tissue was not collected.
measure: Number of Participants With 2-year Recurrence Free Survival
time frame: 4 years
description: To compare the 2-year recurrence free survival (RFS) rate between metformin and observation.
measure: Measure Metformin Sensitivity in Induced Pluripotent Stem Cells (iPS)
time frame: 4 years
description: To develop the metformin sensitivity index based on iPS cell line metformin sensitivity measurements from the first 20 patients randomized to the metformin arm. We will then To apply the metformin sensitivity index on the remaining 25 patients randomized to metformin and the 45 observation patients (70 patients total) to compare the 2-year RFS rate between metformin-sensitive and metformin-not-sensitive patients.
measure: Number of Participants With Adverse Events as a Measure of Safety
time frame: 4 years
description: To compare participant adverse events between metformin and observation arms using CTCAE version 4.
arm group label: Metformin
arm group type: Active Comparator
description: Metformin 850mg twice a day
arm group label: Observation
arm group type: Placebo Comparator
description: Standard of Care Observation
intervention type: Drug
intervention name: Metformin
arm group label: Metformin
other name: Glucophage
intervention type: Other
intervention name: Placebo Comparator
description: Standard of Care Observation
arm group label: Observation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dennis Wigle, MD, PhD
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Dennis Wigle
investigator title: M.D., P.h.D.
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Lung Neoplasms
mesh term: Metformin
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Study terminated due to poor accrual and funding ended
point of contact: 