<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/NCT01671332</url>
  </required_header>
  <id_info>
    <org_study_id>CO11508</org_study_id>
    <secondary_id>A534260</secondary_id>
    <secondary_id>SMPH/MEDICINE/MEDICINE*H</secondary_id>
    <secondary_id>2012-0118</secondary_id>
    <secondary_id>NCI-2012-01113</secondary_id>
    <nct_id>NCT01671332</nct_id>
  </id_info>
  <brief_title>Docetaxel +/- Suramin in 2nd Line Advanced Non-Small Cell Lung Cancer</brief_title>
  <official_title>Randomized Phase II Study of Suramin and Docetaxel Versus Docetaxel in Non-Small Cell Lung Cancer After Failure of First-Line Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Wisconsin, Madison</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medical College of Wisconsin</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Optimum Therapeutics, LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ohio State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Wisconsin, Madison</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 overall purpose of the study is to determine whether or not the inclusion of suramin to&#xD;
      standard treatment with docetaxel improves progression-free survival for patients with&#xD;
      advanced non-small cell lung cancer in the second and third line settings.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The overall purpose of the study is to determine whether or not the inclusion of suramin to&#xD;
      standard treatment with docetaxel improves progression-free survival for patients with&#xD;
      advanced non-small cell lung cancer in the second and third line settings.&#xD;
&#xD;
      Secondary objectives include:&#xD;
&#xD;
        -  To compare response rate of patients in both treatment arms&#xD;
&#xD;
        -  To compare overall survival of patients in both treatment arms&#xD;
&#xD;
        -  To compare toxicity in both treatment arms&#xD;
&#xD;
        -  To determine whether the survival benefit from suramin is associated with reduced&#xD;
           M-phase entry in peripheral blood lymphocytes&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2012</start_date>
  <completion_date type="Actual">June 16, 2016</completion_date>
  <primary_completion_date type="Actual">June 11, 2015</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression-free Survival in Months</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Compare progression-free survival (PFS) in participants with advanced NSCLC treated with docetaxel with or without suramin after failure of first-line chemotherapy. PFS is defined as the duration of time from the time of randomization to time of disease progression or death, whichever occurs first.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Response Rate Per RECIST 1.1 Criteria</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Response rate per RECIST 1.1, as follows:&#xD;
Complete response (CR): Disappearance of all extranodal target lesions. All pathological lymph nodes must have decreased to &lt;10 mm in short axis Partial response (PR): At least 30% decrease in the sum of longest diameters (SLD) of target lesions, taking as reference the baseline sum diameters Progressive disease (PD): SLD increased by at least 20% from the smallest value on study (including baseline, if that is smallest). The SLD must also demonstrate an absolute increase of at least 5 mm. (Two lesions increasing from 2mm to 3mm, for example, does not qualify).&#xD;
Stable disease (SD): Neither sufficient shrinkage to qualify for PR not sufficient increase to qualify for PD</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>Up to 50 months</time_frame>
    <description>Compare overall survival of participants in both treatment arms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Toxicity/Adverse Events From Treatment</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>The investigators will compare the toxicity profiles of the two arms of therapy to determine if the docetaxel + suramin has a more favorable toxicity profile than docetaxel alone. This count includes only adverse events considered definitely, probably, or possibly due to treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of Peripheral Blood Lymphocytes for DNA Damage-induced Checkpoint Control.</measure>
    <time_frame>Baseline</time_frame>
    <description>The investigators hypothesize that suramin in combination with docetaxel improves response rates and survival by increasing the cancer cell population in the M phase of the cell cycle. The G2-M checkpoint control score, defined as (%M-phase arrested cells after cisplatin+suramin)/(%M-phase arrested cells after cisplatin), is an indicator of the effect of suramin on cell accumulation in the M-phase. G2-M checkpoint control was evaluated as a predictor of PFS and OS in participant receiving suramin by linear correlation.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Carcinoma, Non Small Cell Lung</condition>
  <arm_group>
    <arm_group_label>Docetaxel</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Docetaxel plus Suramin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Docetaxel</intervention_name>
    <description>IV over 60 minutes, 75 mg/m2</description>
    <arm_group_label>Docetaxel</arm_group_label>
    <other_name>Taxotere</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Suramin</intervention_name>
    <description>IV over 30 minutes</description>
    <arm_group_label>Docetaxel plus Suramin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Docetaxel</intervention_name>
    <description>IV over 60 minutes. 56 mg/m2</description>
    <arm_group_label>Docetaxel plus Suramin</arm_group_label>
    <other_name>Taxotere</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pathologically proven diagnosis of non-small cell lung cancer&#xD;
&#xD;
          -  Documented disease progression after first-line chemotherapy for non-small cell lung&#xD;
             cancer&#xD;
&#xD;
          -  Stable and treated CNS metastasis is allowed&#xD;
&#xD;
          -  Radiation must be completed at least 2 weeks prior to starting protocol treatment&#xD;
&#xD;
          -  Major surgery must be completed at least 4 weeks prior to starting protocol treatment&#xD;
&#xD;
          -  ECOG performance status 0-2&#xD;
&#xD;
          -  Sexually active patients must use adequate contraception&#xD;
&#xD;
          -  Adequate bone marrow function&#xD;
&#xD;
          -  Adequate renal function&#xD;
&#xD;
          -  Adequate liver function&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe hypersensitivity reaction to docetaxel&#xD;
&#xD;
          -  Pre-existing grade 3 or 4 neuropathy&#xD;
&#xD;
          -  Women who are pregnant or breastfeeding&#xD;
&#xD;
          -  Uncontrolled intercurrent illness&#xD;
&#xD;
          -  Receipt of 3 or more prior chemotherapy regimens&#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>Anne M Traynor, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Wisconsin, Madison</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rafael Santana-Davila, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Medical College of Wisconsin</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Wisconsin Carbone Comprehensive Cancer Center</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53792</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical College of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://cancer.wisc.edu/</url>
    <description>University of Wisconsin Carbone Cancer Center</description>
  </link>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>June 25, 2012</study_first_submitted>
  <study_first_submitted_qc>August 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 23, 2012</study_first_posted>
  <results_first_submitted>October 22, 2019</results_first_submitted>
  <results_first_submitted_qc>May 7, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">May 12, 2020</results_first_posted>
  <disposition_first_submitted>June 29, 2016</disposition_first_submitted>
  <disposition_first_submitted_qc>August 5, 2016</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">September 2, 2016</disposition_first_posted>
  <last_update_submitted>May 7, 2020</last_update_submitted>
  <last_update_submitted_qc>May 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Carcinoma, non small cell lung</keyword>
  <keyword>Second line</keyword>
  <keyword>Third line</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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>Suramin</mesh_term>
    <mesh_term>Docetaxel</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment occurred from June 2012 through April 2014.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Docetaxel</title>
          <description>Docetaxel: IV over 60 minutes, 75 mg/m2&#xD;
Participants with disease progression on the docetaxel arm were allowed to cross over to the suramin arm.</description>
        </group>
        <group group_id="P2">
          <title>Docetaxel Plus Suramin</title>
          <description>Suramin: IV over 30 minutes&#xD;
Docetaxel: IV over 60 minutes. 56 mg/m2</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
                <participants group_id="P2" count="40"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Crossed Over to Docetaxel Plus Suramin</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="13">Participants with disease progression on Docetaxel Arm were allowed to crossover to Suramin.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
                <participants group_id="P2" count="39"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Docetaxel</title>
          <description>Docetaxel: IV over 60 minutes, 75 mg/m2&#xD;
Participants with disease progression on the docetaxel arm were allowed to cross over to the suramin arm.</description>
        </group>
        <group group_id="B2">
          <title>Docetaxel Plus Suramin</title>
          <description>Suramin: IV over 30 minutes&#xD;
Docetaxel: IV over 60 minutes. 56 mg/m2</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="40"/>
            <count group_id="B2" value="40"/>
            <count group_id="B3" value="80"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>18-39 years</title>
              <category_list>
                <category>
                  <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>
              <title>40-49 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>50-59 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60-69 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>70-79 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>80-89 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </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="13"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>White, Not of Hispanic Origin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American, Not of Hispanic Origin</title>
              <category_list>
                <category>
                  <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>
              <title>Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <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>
              <title>Native Hawaiian or Other Pacific Islander</title>
              <category_list>
                <category>
                  <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>
              <title>American Indian or Alaska Native</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </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="40"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Progression-free Survival in Months</title>
        <description>Compare progression-free survival (PFS) in participants with advanced NSCLC treated with docetaxel with or without suramin after failure of first-line chemotherapy. PFS is defined as the duration of time from the time of randomization to time of disease progression or death, whichever occurs first.</description>
        <time_frame>Up to 1 year</time_frame>
        <population>The 13 participants that crossed over to the Docetaxel plus Suramin arm did so after progressing on the standard arm. Their progression-free survival was therefore purely determined by the arm of randomization and not influenced by the cross-over.</population>
        <group_list>
          <group group_id="O1">
            <title>Docetaxel</title>
            <description>Docetaxel: IV over 60 minutes, 75 mg/m2&#xD;
Participants with disease progression on the docetaxel arm were allowed to cross over to the suramin arm.</description>
          </group>
          <group group_id="O2">
            <title>Docetaxel Plus Suramin</title>
            <description>Suramin: IV over 30 minutes&#xD;
Docetaxel: IV over 60 minutes. 56 mg/m2</description>
          </group>
        </group_list>
        <measure>
          <title>Progression-free Survival in Months</title>
          <description>Compare progression-free survival (PFS) in participants with advanced NSCLC treated with docetaxel with or without suramin after failure of first-line chemotherapy. PFS is defined as the duration of time from the time of randomization to time of disease progression or death, whichever occurs first.</description>
          <population>The 13 participants that crossed over to the Docetaxel plus Suramin arm did so after progressing on the standard arm. Their progression-free survival was therefore purely determined by the arm of randomization and not influenced by the cross-over.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.8" lower_limit="0.9" upper_limit="4.2"/>
                    <measurement group_id="O2" value="1.6" lower_limit="1.4" upper_limit="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Response Rate Per RECIST 1.1 Criteria</title>
        <description>Response rate per RECIST 1.1, as follows:&#xD;
Complete response (CR): Disappearance of all extranodal target lesions. All pathological lymph nodes must have decreased to &lt;10 mm in short axis Partial response (PR): At least 30% decrease in the sum of longest diameters (SLD) of target lesions, taking as reference the baseline sum diameters Progressive disease (PD): SLD increased by at least 20% from the smallest value on study (including baseline, if that is smallest). The SLD must also demonstrate an absolute increase of at least 5 mm. (Two lesions increasing from 2mm to 3mm, for example, does not qualify).&#xD;
Stable disease (SD): Neither sufficient shrinkage to qualify for PR not sufficient increase to qualify for PD</description>
        <time_frame>Up to 1 year</time_frame>
        <population>The 13 participants that crossed over to the Docetaxel plus Suramin arm did so after progressing on the standard arm. Their response rate was determined by the arm of randomization and not influenced by the cross-over.</population>
        <group_list>
          <group group_id="O1">
            <title>Docetaxel</title>
            <description>Docetaxel: IV over 60 minutes, 75 mg/m2&#xD;
Participants with disease progression on the docetaxel arm were allowed to cross over to the suramin arm.</description>
          </group>
          <group group_id="O2">
            <title>Docetaxel Plus Suramin</title>
            <description>Suramin: IV over 30 minutes&#xD;
Docetaxel: IV over 60 minutes. 56 mg/m2</description>
          </group>
        </group_list>
        <measure>
          <title>Response Rate Per RECIST 1.1 Criteria</title>
          <description>Response rate per RECIST 1.1, as follows:&#xD;
Complete response (CR): Disappearance of all extranodal target lesions. All pathological lymph nodes must have decreased to &lt;10 mm in short axis Partial response (PR): At least 30% decrease in the sum of longest diameters (SLD) of target lesions, taking as reference the baseline sum diameters Progressive disease (PD): SLD increased by at least 20% from the smallest value on study (including baseline, if that is smallest). The SLD must also demonstrate an absolute increase of at least 5 mm. (Two lesions increasing from 2mm to 3mm, for example, does not qualify).&#xD;
Stable disease (SD): Neither sufficient shrinkage to qualify for PR not sufficient increase to qualify for PD</description>
          <population>The 13 participants that crossed over to the Docetaxel plus Suramin arm did so after progressing on the standard arm. Their response rate was determined by the arm of randomization and not influenced by the cross-over.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Partial Response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stable Disease</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Progressive Disease</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Assessed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival</title>
        <description>Compare overall survival of participants in both treatment arms.</description>
        <time_frame>Up to 50 months</time_frame>
        <population>The 13 participants that crossed over did so after progressing on the standard arm. The overall survival was determined for the arm of randomization without regard of cross-over. Cross-over was provided as option for participants to have the possible benefit of the new treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Docetaxel</title>
            <description>Docetaxel: IV over 60 minutes, 75 mg/m2&#xD;
Participants with disease progression on the docetaxel arm were allowed to cross over to the suramin arm.</description>
          </group>
          <group group_id="O2">
            <title>Docetaxel Plus Suramin</title>
            <description>Suramin: IV over 30 minutes&#xD;
Docetaxel: IV over 60 minutes. 56 mg/m2</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival</title>
          <description>Compare overall survival of participants in both treatment arms.</description>
          <population>The 13 participants that crossed over did so after progressing on the standard arm. The overall survival was determined for the arm of randomization without regard of cross-over. Cross-over was provided as option for participants to have the possible benefit of the new treatment.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.3" lower_limit="5.0" upper_limit="8.0"/>
                    <measurement group_id="O2" value="4.1" lower_limit="3.2" upper_limit="7.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Toxicity/Adverse Events From Treatment</title>
        <description>The investigators will compare the toxicity profiles of the two arms of therapy to determine if the docetaxel + suramin has a more favorable toxicity profile than docetaxel alone. This count includes only adverse events considered definitely, probably, or possibly due to treatment.</description>
        <time_frame>Up to 2 years</time_frame>
        <population>The 13 participants that crossed over did so after progressing on the standard arm. Reported here are the number of participants who experienced adverse events on the arm of randomization.</population>
        <group_list>
          <group group_id="O1">
            <title>Docetaxel</title>
            <description>Docetaxel: IV over 60 minutes, 75 mg/m2&#xD;
Participants with disease progression on the docetaxel arm were allowed to cross over to the suramin arm.</description>
          </group>
          <group group_id="O2">
            <title>Docetaxel Plus Suramin</title>
            <description>Suramin: IV over 30 minutes&#xD;
Docetaxel: IV over 60 minutes. 56 mg/m2</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Toxicity/Adverse Events From Treatment</title>
          <description>The investigators will compare the toxicity profiles of the two arms of therapy to determine if the docetaxel + suramin has a more favorable toxicity profile than docetaxel alone. This count includes only adverse events considered definitely, probably, or possibly due to treatment.</description>
          <population>The 13 participants that crossed over did so after progressing on the standard arm. Reported here are the number of participants who experienced adverse events on the arm of randomization.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Evaluation of Peripheral Blood Lymphocytes for DNA Damage-induced Checkpoint Control.</title>
        <description>The investigators hypothesize that suramin in combination with docetaxel improves response rates and survival by increasing the cancer cell population in the M phase of the cell cycle. The G2-M checkpoint control score, defined as (%M-phase arrested cells after cisplatin+suramin)/(%M-phase arrested cells after cisplatin), is an indicator of the effect of suramin on cell accumulation in the M-phase. G2-M checkpoint control was evaluated as a predictor of PFS and OS in participant receiving suramin by linear correlation.</description>
        <time_frame>Baseline</time_frame>
        <population>All participants who yielded good quality PBL samples were included.</population>
        <group_list>
          <group group_id="O1">
            <title>Docetaxel</title>
            <description>Docetaxel: IV over 60 minutes, 75 mg/m2&#xD;
Participants with disease progression on the docetaxel arm were allowed to cross over to the suramin arm.</description>
          </group>
          <group group_id="O2">
            <title>Docetaxel Plus Suramin</title>
            <description>Suramin: IV over 30 minutes&#xD;
Docetaxel: IV over 60 minutes. 56 mg/m2</description>
          </group>
        </group_list>
        <measure>
          <title>Evaluation of Peripheral Blood Lymphocytes for DNA Damage-induced Checkpoint Control.</title>
          <description>The investigators hypothesize that suramin in combination with docetaxel improves response rates and survival by increasing the cancer cell population in the M phase of the cell cycle. The G2-M checkpoint control score, defined as (%M-phase arrested cells after cisplatin+suramin)/(%M-phase arrested cells after cisplatin), is an indicator of the effect of suramin on cell accumulation in the M-phase. G2-M checkpoint control was evaluated as a predictor of PFS and OS in participant receiving suramin by linear correlation.</description>
          <population>All participants who yielded good quality PBL samples were included.</population>
          <units>G2-M checkpoint control score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.91" spread="0.37"/>
                    <measurement group_id="O2" value="1.30" spread="0.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days.</time_frame>
      <desc>AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.</desc>
      <group_list>
        <group group_id="E1">
          <title>Docetaxel</title>
          <description>Docetaxel: IV over 60 minutes, 75 mg/m2&#xD;
Participants with disease progression on the docetaxel arm were allowed to cross over to the suramin arm.</description>
        </group>
        <group group_id="E2">
          <title>Docetaxel Plus Suramin</title>
          <description>Suramin: IV over 30 minutes&#xD;
Docetaxel: IV over 60 minutes. 56 mg/m2</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="40" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="37" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="26" subjects_at_risk="53"/>
              </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="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Pericarditis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Sinus tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Esophageal obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Lower gastrointestinal hemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Death NOS</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="40"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Gait disturbance</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Multi-organ failure</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaphylaxis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Catheter related infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Lung infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Soft tissue infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Radiation recall reaction (dermatologic)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>INR increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Hypoalbuminemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Hypocalcemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Hypokalemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Hyponatremia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Hyperglycemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Generalized muscle weakness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Muscle weakness upper limb</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Muscle Weakness Right-Sided</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Intracranial hemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Stroke</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Confusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Bronchopulmonary hemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Peripheal ischemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Thromboembolic Event</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </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="39" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="49" subjects_at_risk="53"/>
              </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="9" subjects_affected="8" subjects_at_risk="40"/>
                <counts group_id="E2" events="15" subjects_affected="14" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Blood any lymphatic system disorders - Other</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Blurred vision</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Watering eyes</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E2" events="4" subjects_affected="1" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="40"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Gastrointestinal disorders - Other</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Mucositis oral</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="40"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="9" subjects_affected="7" subjects_at_risk="40"/>
                <counts group_id="E2" events="12" subjects_affected="10" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Salivary duct inflammation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Stomach pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="40"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Death NOS</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Edema limbs</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="24" subjects_affected="18" subjects_at_risk="40"/>
                <counts group_id="E2" events="35" subjects_affected="22" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>General disorders and administration site conditions - Other</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="9" subjects_affected="5" subjects_at_risk="40"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchial infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Lung infection</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="40"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Mucosal infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Upper respiratory infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Alkaline phosphatase increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Cardiac troponin I increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>CPK increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Creatinine increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Ejection fraction decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>INR increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Lymphocyte count decreased</sub_title>
                <counts group_id="E1" events="26" subjects_affected="9" subjects_at_risk="40"/>
                <counts group_id="E2" events="18" subjects_affected="9" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" events="27" subjects_affected="16" subjects_at_risk="40"/>
                <counts group_id="E2" events="16" subjects_affected="8" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>White blood cell decreased</sub_title>
                <counts group_id="E1" events="27" subjects_affected="16" subjects_at_risk="40"/>
                <counts group_id="E2" events="20" subjects_affected="10" subjects_at_risk="53"/>
              </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="6" subjects_at_risk="40"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="40"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Hyperglycemia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="40"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Hypoalbuminemia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Hypocalcemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Hypoglycemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Hypokalemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="9" subjects_affected="7" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Hyponatremia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="40"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="40"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Generalized muscle weakness</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="40"/>
                <counts group_id="E2" events="7" subjects_affected="5" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Muscle weakness right-sided</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Musculoskeletal and connective tissue disorder - Other</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Ataxia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E2" events="5" subjects_affected="3" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Nervous system disorders - Other</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Peripheral motor neurpathy</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="40"/>
                <counts group_id="E2" events="8" subjects_affected="6" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic kidney disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Allergic rhinitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="40"/>
                <counts group_id="E2" events="13" subjects_affected="11" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Pleuritic pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Postnasal drip</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Productive cough</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Respiratory, thoracic and mediastinal disorders - Other</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Sore throat</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Voice alteration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="40"/>
                <counts group_id="E2" events="9" subjects_affected="8" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Nail ridging</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Pain of skin</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Palmar-plantar erythrodysesthesia syndrome</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Rash acneiform</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Skin and subcutaneous tissue disorders - Other</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hot flashes</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="7" subjects_affected="4" subjects_at_risk="40"/>
                <counts group_id="E2" events="10" subjects_affected="4" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Superficial thrombophlebitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Thromboembolic event</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="40"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="53"/>
              </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>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Anne Traynor</name_or_title>
      <organization>University of Wisconsin</organization>
      <phone>608-262-5092</phone>
      <email>amt@medicine.wisc.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/NCT01671332
org study id: CO11508
secondary id: A534260
secondary id: SMPH/MEDICINE/MEDICINE*H
secondary id: 2012-0118
secondary id: NCI-2012-01113
nct id: NCT01671332
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The overall purpose of the study is to determine whether or not the inclusion of suramin to
      standard treatment with docetaxel improves progression-free survival for patients with
      advanced non-small cell lung cancer in the second and third line settings.
The overall purpose of the study is to determine whether or not the inclusion of suramin to
      standard treatment with docetaxel improves progression-free survival for patients with
      advanced non-small cell lung cancer in the second and third line settings.

      Secondary objectives include:

        -  To compare response rate of patients in both treatment arms

        -  To compare overall survival of patients in both treatment arms

        -  To compare toxicity in both treatment arms

        -  To determine whether the survival benefit from suramin is associated with reduced
           M-phase entry in peripheral blood lymphocytes
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression-free Survival in Months
time frame: Up to 1 year
description: Compare progression-free survival (PFS) in participants with advanced NSCLC treated with docetaxel with or without suramin after failure of first-line chemotherapy. PFS is defined as the duration of time from the time of randomization to time of disease progression or death, whichever occurs first.
measure: Response Rate Per RECIST 1.1 Criteria
time frame: Up to 1 year
description: Response rate per RECIST 1.1, as follows:
Complete response (CR): Disappearance of all extranodal target lesions. All pathological lymph nodes must have decreased to <10 mm in short axis Partial response (PR): At least 30% decrease in the sum of longest diameters (SLD) of target lesions, taking as reference the baseline sum diameters Progressive disease (PD): SLD increased by at least 20% from the smallest value on study (including baseline, if that is smallest). The SLD must also demonstrate an absolute increase of at least 5 mm. (Two lesions increasing from 2mm to 3mm, for example, does not qualify).
Stable disease (SD): Neither sufficient shrinkage to qualify for PR not sufficient increase to qualify for PD
measure: Overall Survival
time frame: Up to 50 months
description: Compare overall survival of participants in both treatment arms.
measure: Number of Participants With Toxicity/Adverse Events From Treatment
time frame: Up to 2 years
description: The investigators will compare the toxicity profiles of the two arms of therapy to determine if the docetaxel + suramin has a more favorable toxicity profile than docetaxel alone. This count includes only adverse events considered definitely, probably, or possibly due to treatment.
measure: Evaluation of Peripheral Blood Lymphocytes for DNA Damage-induced Checkpoint Control.
time frame: Baseline
description: The investigators hypothesize that suramin in combination with docetaxel improves response rates and survival by increasing the cancer cell population in the M phase of the cell cycle. The G2-M checkpoint control score, defined as (%M-phase arrested cells after cisplatin+suramin)/(%M-phase arrested cells after cisplatin), is an indicator of the effect of suramin on cell accumulation in the M-phase. G2-M checkpoint control was evaluated as a predictor of PFS and OS in participant receiving suramin by linear correlation.
arm group label: Docetaxel
arm group type: Active Comparator
arm group label: Docetaxel plus Suramin
arm group type: Experimental
intervention type: Drug
intervention name: Docetaxel
description: IV over 60 minutes, 75 mg/m2
arm group label: Docetaxel
other name: Taxotere
intervention type: Drug
intervention name: Suramin
description: IV over 30 minutes
arm group label: Docetaxel plus Suramin
intervention type: Drug
intervention name: Docetaxel
description: IV over 60 minutes. 56 mg/m2
arm group label: Docetaxel plus Suramin
other name: Taxotere
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Anne M Traynor, MD
role: Principal Investigator
affiliation: University of Wisconsin, Madison
last name: Rafael Santana-Davila, MD
role: Study Chair
affiliation: Medical College of Wisconsin
facility: 
facility: 
country: United States
url: https://cancer.wisc.edu/
description: University of Wisconsin Carbone Cancer Center
responsible party type: Sponsor
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Suramin
mesh term: Docetaxel
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 