<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/NCT01676714</url>
  </required_header>
  <id_info>
    <org_study_id>UCDCC#231</org_study_id>
    <secondary_id>344991</secondary_id>
    <secondary_id>CTKI258AUS21T</secondary_id>
    <nct_id>NCT01676714</nct_id>
  </id_info>
  <brief_title>Study of Dovitinib and Biomarkers in Advanced Non-Small Cell Lung Cancer or Advanced Colorectal Cancer</brief_title>
  <official_title>Phase II Study of Dovitinib and Pilot Study of Fibroblast Growth Factor Receptor Biomarkers in Advanced Non-Small Cell Lung Cancer or Advanced Colorectal Cancer Previously Treated With Anti-Vascular Endothelial Growth Factor Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Davis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Novartis</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, Davis</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to find out if dovitinib is an effective treatment for patients&#xD;
      with advanced lung cancer or advanced colorectal cancer (CRC) who have progressed on&#xD;
      anti-vascular endothelial growth factor (VEGF) treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purposes of this study are 1) to evaluate the clinical efficacy of dovitinib and 2) to&#xD;
      prospectively estimate the prevalence of fibroblast growth factor (FGF) signaling alterations&#xD;
      in patients with advanced non-squamous non small cell lung cancer (NSCLC) or advanced CRC who&#xD;
      have progressed on anti-VEGF treatment. Additionally, the investigators will make exploratory&#xD;
      initial observations of the relationship between FGF signaling alterations and the clinical&#xD;
      activity of dovitinib. This trial is expected to provide key biologic information that will&#xD;
      inform the clinical development of dovitinib and provide initial evaluation of the analytic&#xD;
      characteristics of these potential predictive biomarkers of its efficacy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2013</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</primary_completion_date>
  <phase>Phase 2</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>Overall Response Rate</measure>
    <time_frame>Up to 100 months</time_frame>
    <description>Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), &gt;=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Disease Control Rate</measure>
    <time_frame>From start of treatment, up to 8 weeks</time_frame>
    <description>The total number of patients who demonstrate a response to treatment. Measured by RECIST 1.1 criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival</measure>
    <time_frame>From start of treatment until the date of death from any cause, assessed up to 100 months</time_frame>
    <description>The length of time during and after the treatment of the cancer that a patient lives with the disease but it does not get worse. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients Who Experienced Treatment Related Toxicities</measure>
    <time_frame>Starting at screening and then at every visit and then up to 30 days after the last dose of study treatment.</time_frame>
    <description>Toxicities will be summarized by the type, severity (by NCI CTCAE), time of onset, duration, and outcome. Toxicity will be graded according to the NCI CTCAE version 4.0.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Non-Small Cell Lung Cancer</condition>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>Dovitinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>500 mg of dovitinib (5 capsules) once a day for 5 continuous days and stop for 2 days. Continue to take dovitinib capsules in this manner until until progression or unacceptable toxicity develops.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dovitinib</intervention_name>
    <arm_group_label>Dovitinib</arm_group_label>
    <other_name>TK1258</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed non-small cell lung cancer or colorectal cancer for which no&#xD;
             potentially curative treatment options are available&#xD;
&#xD;
          -  Any number of prior treatment regimens are allowed&#xD;
&#xD;
          -  Immediate prior treatment regimen must have included an anti-VEGF agent. Acceptable&#xD;
             anti-VEGF therapy includes bevacizumab, sunitinib, or sorafenib. For other anti-VEGF&#xD;
             therapies, contact the principal investigator.&#xD;
&#xD;
          -  Last dose administered of bevacizumab must be at least 21-days but not more than&#xD;
             56-days from enrollment.&#xD;
&#xD;
          -  Last dose of anti-VEGF tyrosine kinase inhibitor must be at least 7-days but not more&#xD;
             than 56-days from enrollment.&#xD;
&#xD;
          -  Willingness to consent to research biopsy&#xD;
&#xD;
          -  Measurable disease by RECIST 1.1 criteria&#xD;
&#xD;
          -  Available tumor site amenable to core needle biopsy as determined by the treating&#xD;
             investigator. Any questions regarding suitability of site for biopsy will be&#xD;
             adjudicated by the principal investigator.&#xD;
&#xD;
          -  Zubrod (ECOG) performance status 0 or 1&#xD;
&#xD;
          -  Age ≥ 18 years old&#xD;
&#xD;
          -  Patients who give a written informed consent&#xD;
&#xD;
          -  Patients must have the following laboratory values:&#xD;
&#xD;
               -  Platelets ≥ 100 x 109/L&#xD;
&#xD;
               -  Absolute neutrophil count ≥ 1.5 x 109/L Hemoglobin &gt; 9 g/dL&#xD;
&#xD;
               -  Serum total bilirubin: ≤ 1.5 x upper limit of normal ULN&#xD;
&#xD;
               -  ALT and AST ≤ 3.0 x ULN ( with or without liver metastases)&#xD;
&#xD;
               -  Serum creatinine ≤ 1.5 x ULN or serum creatinine &gt;1.5 - 3 x ULN&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with known brain metastases&#xD;
&#xD;
          -  Patients with another primary malignancy within 3 years prior to starting study drug,&#xD;
             with the exception of adequately treated in-situ carcinoma of the uterine cervix, or&#xD;
             skin cancer&#xD;
&#xD;
          -  Patients who have received the last administration of an anticancer therapy including&#xD;
             chemotherapy, immunotherapy, hormonal therapy and monoclonal antibodies that have not&#xD;
             resolved to NCI CTCAE grade 1 or less.&#xD;
&#xD;
          -  Patients who have received the last administration of nitrosurea or mitomycin-C ≤ 6&#xD;
             weeks prior to starting study drug, or who have side effects that have not resolved to&#xD;
             NCI CTCAE grade 1 or less.&#xD;
&#xD;
          -  Patients who have received targeted therapy ≤ 1 week prior to starting study drug, or&#xD;
             who have not recovered from the side effects of such therapy&#xD;
&#xD;
          -  Patients who have had radiotherapy ≤ 4 weeks prior to starting study drug, or ≤ 2&#xD;
             weeks prior to starting study drug in the case of localized radiotherapy or who have&#xD;
             not recovered from radiotherapy toxicities&#xD;
&#xD;
          -  Patients who have undergone major surgery, open biopsy or significant traumatic injury&#xD;
             ≤ 4 weeks prior to starting study drug, or patients who have had minor procedures,&#xD;
             percutaneous biopsies or placement of vascular access device ≤ 1 week prior to&#xD;
             starting study drug, or who have not recovered from side effects of such procedure or&#xD;
             injury&#xD;
&#xD;
          -  Patients with any of the following concurrent severe and/or uncontrolled medical&#xD;
             conditions which could compromise participation in the study:&#xD;
&#xD;
               -  Impaired cardiac function or clinically significant cardiac diseases&#xD;
&#xD;
               -  Impairment of gastrointestinal (GI) function or GI disease that may significantly&#xD;
                  alter the absorption of dovitinib&#xD;
&#xD;
               -  Cirrhosis, chronic active hepatitis or chronic persistent hepatitis&#xD;
&#xD;
               -  Known diagnosis of human immunodeficiency virus infection&#xD;
&#xD;
               -  Patients who are currently receiving anticoagulation treatment with therapeutic&#xD;
                  doses of warfarin&#xD;
&#xD;
               -  Other concurrent severe and/or uncontrolled concomitant medical conditions&#xD;
&#xD;
          -  Pregnant or breast-feeding women&#xD;
&#xD;
          -  Women of child-bearing potential, who are biologically able to conceive, not employing&#xD;
             two forms of highly effective contraception.&#xD;
&#xD;
          -  Fertile males not willing to use contraception, as stated above&#xD;
&#xD;
          -  Patients unwilling or unable to comply with the protocol&#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>Thomas Semrad, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Davis</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California Comprehensive Cancer Center</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>August 27, 2012</study_first_submitted>
  <study_first_submitted_qc>August 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 31, 2012</study_first_posted>
  <results_first_submitted>March 17, 2017</results_first_submitted>
  <results_first_submitted_qc>May 8, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">May 15, 2017</results_first_posted>
  <last_update_submitted>January 5, 2018</last_update_submitted>
  <last_update_submitted_qc>January 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dovitinib</keyword>
  <keyword>Fibroblast Growth Factor Receptor Biomarkers</keyword>
  <keyword>Anti-Vascular Endothelial Growth Factor Therapy</keyword>
  <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>
    <mesh_term>Colorectal Neoplasms</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Dovitinib</title>
          <description>500 mg of dovitinib (5 capsules) once a day for 5 continuous days and stop for 2 days. Continue to take dovitinib capsules in this manner until until progression or unacceptable toxicity develops.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Dovitinib</title>
          <description>500 mg of dovitinib (5 capsules) once a day for 5 continuous days and stop for 2 days. Continue to take dovitinib capsules in this manner until until progression or unacceptable toxicity develops.&#xD;
Dovitinib</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="10"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63" lower_limit="48" upper_limit="77"/>
                  </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="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Overall Response Rate</title>
        <description>Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), &gt;=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.</description>
        <time_frame>Up to 100 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dovitinib</title>
            <description>500 mg of dovitinib (5 capsules) once a day for 5 continuous days and stop for 2 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Response Rate</title>
          <description>Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), &gt;=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Disease Control Rate</title>
        <description>The total number of patients who demonstrate a response to treatment. Measured by RECIST 1.1 criteria.</description>
        <time_frame>From start of treatment, up to 8 weeks</time_frame>
        <population>500 mg of dovitinib (5 capsules) once a day for 5 continuous days and stop for 2 days. Continue to take dovitinib capsules in this manner until progression or unacceptable toxicity develops.</population>
        <group_list>
          <group group_id="O1">
            <title>Dovitinib</title>
            <description>500 mg of dovitinib (5 capsules) once a day for 5 continuous days and stop for 2 days. Continue to take dovitinib capsules in this manner until until progression or unacceptable toxicity develops.</description>
          </group>
        </group_list>
        <measure>
          <title>Disease Control Rate</title>
          <description>The total number of patients who demonstrate a response to treatment. Measured by RECIST 1.1 criteria.</description>
          <population>500 mg of dovitinib (5 capsules) once a day for 5 continuous days and stop for 2 days. Continue to take dovitinib capsules in this manner until progression or unacceptable toxicity develops.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression Free Survival</title>
        <description>The length of time during and after the treatment of the cancer that a patient lives with the disease but it does not get worse. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.</description>
        <time_frame>From start of treatment until the date of death from any cause, assessed up to 100 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dovitinib</title>
            <description>500 mg of dovitinib (5 capsules) once a day for 5 continuous days and stop for 2 days. Continue to take dovitinib capsules in this manner until until progression or unacceptable toxicity develops.</description>
          </group>
        </group_list>
        <measure>
          <title>Progression Free Survival</title>
          <description>The length of time during and after the treatment of the cancer that a patient lives with the disease but it does not get worse. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.</description>
          <units>months</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9" lower_limit="0.23" upper_limit="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients Who Experienced Treatment Related Toxicities</title>
        <description>Toxicities will be summarized by the type, severity (by NCI CTCAE), time of onset, duration, and outcome. Toxicity will be graded according to the NCI CTCAE version 4.0.</description>
        <time_frame>Starting at screening and then at every visit and then up to 30 days after the last dose of study treatment.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dovitinib</title>
            <description>500 mg of dovitinib (5 capsules) once a day for 5 continuous days and stop for 2 days. Continue to take dovitinib capsules in this manner until until progression or unacceptable toxicity develops.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients Who Experienced Treatment Related Toxicities</title>
          <description>Toxicities will be summarized by the type, severity (by NCI CTCAE), time of onset, duration, and outcome. Toxicity will be graded according to the NCI CTCAE version 4.0.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 30 days after treatment</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Dovitinib</title>
          <description>500 mg of dovitinib (5 capsules) once a day for 5 continuous days and stop for 2 days. Continue to take dovitinib capsules in this manner until until progression or unacceptable toxicity develops.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>CTCAE (4.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Esophageal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Thrombolic Event</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>CTCAE (4.0)</default_vocab>
        <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="10" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Bloating</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Edema Limbs</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>ALT Increased</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Alkaline phosphatase increased</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>AST increased</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Blood Bilirubin Increased</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Cholesterol High</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>GCT Increased</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Lymphocyte count decreased</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Other - LDH Increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Weight Loss</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Anorexia</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hypoalbuminemia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hypoatremia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hypertriglyceridemia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>General Muscle Weakness</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dry Skin</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="10"/>
              </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>
    <point_of_contact>
      <name_or_title>Analyst</name_or_title>
      <organization>University of California Davis</organization>
      <phone>916 734 0294</phone>
      <email>pkaujla@ucdavis.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/NCT01676714
org study id: UCDCC#231
secondary id: 344991
secondary id: CTKI258AUS21T
nct id: NCT01676714
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to find out if dovitinib is an effective treatment for patients
      with advanced lung cancer or advanced colorectal cancer (CRC) who have progressed on
      anti-vascular endothelial growth factor (VEGF) treatment.
The purposes of this study are 1) to evaluate the clinical efficacy of dovitinib and 2) to
      prospectively estimate the prevalence of fibroblast growth factor (FGF) signaling alterations
      in patients with advanced non-squamous non small cell lung cancer (NSCLC) or advanced CRC who
      have progressed on anti-VEGF treatment. Additionally, the investigators will make exploratory
      initial observations of the relationship between FGF signaling alterations and the clinical
      activity of dovitinib. This trial is expected to provide key biologic information that will
      inform the clinical development of dovitinib and provide initial evaluation of the analytic
      characteristics of these potential predictive biomarkers of its efficacy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall Response Rate
time frame: Up to 100 months
description: Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
measure: Disease Control Rate
time frame: From start of treatment, up to 8 weeks
description: The total number of patients who demonstrate a response to treatment. Measured by RECIST 1.1 criteria.
measure: Progression Free Survival
time frame: From start of treatment until the date of death from any cause, assessed up to 100 months
description: The length of time during and after the treatment of the cancer that a patient lives with the disease but it does not get worse. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
measure: Number of Patients Who Experienced Treatment Related Toxicities
time frame: Starting at screening and then at every visit and then up to 30 days after the last dose of study treatment.
description: Toxicities will be summarized by the type, severity (by NCI CTCAE), time of onset, duration, and outcome. Toxicity will be graded according to the NCI CTCAE version 4.0.
arm group label: Dovitinib
arm group type: Experimental
description: 500 mg of dovitinib (5 capsules) once a day for 5 continuous days and stop for 2 days. Continue to take dovitinib capsules in this manner until until progression or unacceptable toxicity develops.
intervention type: Drug
intervention name: Dovitinib
arm group label: Dovitinib
other name: TK1258
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Thomas Semrad, MD
role: Principal Investigator
affiliation: University of California, Davis
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Colorectal Neoplasms
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 