<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/NCT01669798</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00033060</org_study_id>
    <nct_id>NCT01669798</nct_id>
  </id_info>
  <brief_title>BIBF 1120 in Bevacizumab Resistant, Persistent, or Recurrent Epithelial Ovarian Cancer</brief_title>
  <official_title>Phase II Evaluation of BIBF 1120 in the Treatment of Bevacizumab-Resistant, Persistent, or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AA Secord</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purpose of this study is to see if BIBF 1120 can increase the number of women with&#xD;
      bevacizumab resistant, persistent, or recurrent epithelial ovarian cancer who do not progress&#xD;
      for at least six months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ovarian cancer patients with platinum-resistant and refractory disease have the lowest&#xD;
      response rates to relapse chemotherapy: various chemotherapeutic agents, such as paclitaxel,&#xD;
      liposomal doxorubicin, topotecan, docetaxel, platinum, etoposide, ifosfamide, gemcitabine,&#xD;
      and vinorelbine are available but result in response rates of 7-40%. Unfortunately, relapse&#xD;
      therapy is not curative and treatment is only palliative. Recently two phase II trials&#xD;
      demonstrated that anti-angiogenic therapy with bevacizumab alone or in combination with&#xD;
      chemotherapy in women with recurrent disease had response rates ranging from 16-24% with an&#xD;
      acceptable toxicity profile. However, resistance can develop to VEGF inhibition. Therefore&#xD;
      other novel anti-angiogenic agents, such as BIBF 1120, should be evaluated in the treatment&#xD;
      of ovarian cancer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2013</start_date>
  <completion_date type="Actual">February 2018</completion_date>
  <primary_completion_date type="Actual">September 10, 2017</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Patients Who Survive Progression-free</measure>
    <time_frame>6 months</time_frame>
    <description>Measure of Progression Free Survival (PFS) by the percentage of patients who survive progression-free for at least 6 months after initiating study therapy in patients with bevacizumab-resistant, persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective Tumor Response Via RECIST (Response Evaluation Criteria in Solid Tumors) 1.1</measure>
    <time_frame>1 year</time_frame>
    <description>Evaluating the percentage of patients who have objective tumor response (complete or partial) based on RECIST 1.1 criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Progression-Free Survival</measure>
    <time_frame>Through study completion, on average 2 years</time_frame>
    <description>The duration of progression-free survival and overall survival measured in months; Progression-Free Survival (PFS) is defined as the duration of time from study entry to time of progression or death, whichever occurs first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Tumor Response Based on GCIG CA-125 Criteria</measure>
    <time_frame>1 year</time_frame>
    <description>The proportion of patients who have objective tumor response (complete or partial) based on Gynaecologic Cancer InterGroup(GCIG) CA-125 criteria which is: &quot;A response according to CA 125 has occurred if there is at least a 50% reduction in CA 125 levels from a pretreatment sample. The response must be confirmed and maintained for at least 28 days.&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Event Frequency and Severity</measure>
    <time_frame>1 year</time_frame>
    <description>To determine frequency and severity of adverse events as assessed using NCI Common Toxicity Criteria version 4.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Concentration of Select Growth Factors Reported Measured in Picograms Per Milliliter as a Function of Treatment Response</measure>
    <time_frame>1 year</time_frame>
    <description>Correlating baseline and on treatment levels of additional growth factors measured in picograms per milliliter that may be co- or counter- regulated with VEGF with response to treatment</description>
  </other_outcome>
  <other_outcome>
    <measure>Coagulation and Endothelial Cell Activation Markers</measure>
    <time_frame>1 year</time_frame>
    <description>To measure baseline and on treatment levels of additional growth factors that may be co- or counter- regulated with VEGF and correlate with response to treatment.</description>
  </other_outcome>
  <other_outcome>
    <measure>VEGF Levels Correlated With Treatment Outcome</measure>
    <time_frame>1 year</time_frame>
    <description>Baseline levels of VEGF were correlated with treatment outcome. Results are stratified in groups: &quot;Partial Response (PR) or Stable Disease (SD)&quot; and &quot;Progressive Disease (PD)&quot;</description>
  </other_outcome>
  <other_outcome>
    <measure>Concentration of Select Growth Factors Measured in Nanograms Per Milliliter Reported as a Function of Treatment Response</measure>
    <time_frame>1 year</time_frame>
    <description>Correlating baseline and on treatment levels of additional growth factors measured in nanograms per milliliter that may be co- or counter- regulated with VEGF with response to treatment</description>
  </other_outcome>
  <other_outcome>
    <measure>Concentration of VCAM-1 Reported as a Function of Treatment Response</measure>
    <time_frame>1 year</time_frame>
    <description>Correlating baseline and on treatment levels of VCAM-1 measured in micrograms per milliliter that may be co- or counter- regulated with VEGF with response to treatment</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Ovarian Cancer</condition>
  <condition>Fallopian Tube Cancer</condition>
  <condition>Peritoneal Cancer</condition>
  <arm_group>
    <arm_group_label>BIBF 1120</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BIBF 1120 will be administered at a daily oral dose of 200 mg BID until disease progression or adverse effects prohibit further therapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BIBF 1120</intervention_name>
    <description>PO 200mg BID</description>
    <arm_group_label>BIBF 1120</arm_group_label>
    <other_name>Vargatef™</other_name>
    <other_name>Nintedanib</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal&#xD;
             carcinoma w/ histologic documentation of the original primary tumor via the pathology&#xD;
             report:&#xD;
&#xD;
               -  serious, endometrioid, mucinous, or clear cell adenocarcinoma&#xD;
&#xD;
               -  undifferentiated, mixed epithelial or transitional cell carcinoma&#xD;
&#xD;
               -  Brenner's Tumor&#xD;
&#xD;
               -  adenocarcinoma NOS&#xD;
&#xD;
          -  Had treatment-free interval following response to bevacizumab (CR, PR, or SD) of &lt; 6&#xD;
             months, or have progressed during treatment w/ a bevacizumab-containing therapy&#xD;
&#xD;
          -  Measurable or detectable disease. Measurable is defined by RECIST 1.1. Each lesion&#xD;
             must be ≥ 10 mm when measured by CT, MRI or caliper measurement by clinical exam; or ≥&#xD;
             20 mm when measured by chest x-ray. Lymph nodes must be &gt; 15 mm in short axis when&#xD;
             measured by CT or MRI. Detectable defined as no measurable disease but either&#xD;
             ascities/pleural effusion or solid/cystic abnormalities that don't meet RECIST 1.1 -&#xD;
             both within the setting of CA125 &gt;2xULN&#xD;
&#xD;
          -  Those with measurable disease must have at least one &quot;target lesion&quot; to assess&#xD;
             response as defined by RECIST 1.1. Tumors in a previously irradiated field will be&#xD;
             designated as &quot;non-target&quot; lesions&#xD;
&#xD;
          -  Must have a ECOG Performance Status of 0 or 1&#xD;
&#xD;
          -  Free of active infection requiring antibiotics. Exception: uncomplicated UTI&#xD;
&#xD;
          -  Recovery from effects of recent surgery, radiotherapy, or chemotherapy&#xD;
&#xD;
               -  Hormonal therapy directed at the malignant tumor must be d/c at least a week&#xD;
                  prior to registration. Hormone replacement therapy is permitted&#xD;
&#xD;
               -  Other prior therapy directed at malignant tumor, including immunologic agents,&#xD;
                  must be d/c at least 3 weeks prior to registration; 4 weeks if prior therapy was&#xD;
                  w/ bevacizumab&#xD;
&#xD;
          -  Prior therapy&#xD;
&#xD;
               -  must have had one prior platinum-based chemotherapeutic regimen for management of&#xD;
                  primary disease containing carboplatin, cisplatin, or another organoplatinum&#xD;
                  compound. This initial treatment may have included intraperitoneal therapy,&#xD;
                  high-dose therapy, consolidation, non-cytotoxic agents or extended therapy&#xD;
                  administered after surgical or non-surgical assessment.&#xD;
&#xD;
               -  Allowed, to receive, but not required to receive, 2 additional cytotoxic regimens&#xD;
                  for management of recurrent or persistent disease according to the following:&#xD;
&#xD;
                    -  Patients who have received only one prior cytotoxic regimen (platinum-based&#xD;
                       regimen for management of primary disease), must have a platinum-free&#xD;
                       interval of less than 12 months, or have progressed during platinum-based&#xD;
                       therapy, or have persistent disease after a platinum-based therapy.&#xD;
&#xD;
                    -  Patients must NOT have received any non-cytotoxic therapy for management of&#xD;
                       recurrent or persistent disease other than bevacizumab. Patients are allowed&#xD;
                       to receive, but are not required to receive, biologic (non-cytotoxic)&#xD;
                       therapy as part of their primary treatment regimen.&#xD;
&#xD;
          -  Must have adequate:&#xD;
&#xD;
               -  Bone marrow function: Absolute neutrophil count (ANC) ≥ 1,500/mcl, equivalent to&#xD;
                  (CTCAE v4.0) grade 1. Platelets ≥ 100,000/mcl. Hemoglobin (Hb) ≥ 9.0 g/dL&#xD;
&#xD;
               -  Renal function: creatinine ≤ 1.5 x upper limit of normal (ULN)&#xD;
&#xD;
               -  Hepatic function: Bilirubin should be w/in normal limits (CTCAE v4.0, grade 1).&#xD;
                  ALT/AST, should be ≤ 1.5 x ULN (CTCAE v4.0, grade 1). For patients w/ liver&#xD;
                  metastases, ALT/AST should be ≤ 2.5 x ULN; Alkaline phosphatase should be ≤ 2.5 x&#xD;
                  ULN (CTCAE v4.0, grade 1)&#xD;
&#xD;
               -  Neurologic function: Neuropathy ≤ CTCAE v4.0, grade 1&#xD;
&#xD;
          -  Blood coagulation parameters: PT w/ international normalized ratio (INR) &lt; 1.5 x ULN &amp;&#xD;
             a PTT &lt; 1.5 x ULN (or an in-range PTT if on a stable dose of therapeutic heparin). Low&#xD;
             molecular weight heparin (enoxaparin or alternative anticoagulants (other than&#xD;
             warfarin)) are acceptable.&#xD;
&#xD;
          -  Signed informed consent &amp; authorization permitting release of personal health&#xD;
             information&#xD;
&#xD;
          -  Negative serum pregnancy test if of childbearing potential prior to study entry &amp; use&#xD;
             of effective form of contraception until 3 months after receiving last drug treatment&#xD;
&#xD;
          -  Patients may have undergone a major or minor surgical procedure as long as:&#xD;
&#xD;
               -  &gt; 28 days prior to the first date of study therapy&#xD;
&#xD;
               -  Core biopsy or IV Port placement greater than 7 days prior to the first date of&#xD;
                  study therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous treatment w/ BIBF 1120.&#xD;
&#xD;
          -  Pregnant or breastfeeding.&#xD;
&#xD;
          -  Received radiation to more than 25% of marrow-bearing areas&#xD;
&#xD;
          -  History of other invasive malignancies, w/ the exception of non-melanoma skin cancer,&#xD;
             if there is any evidence of other malignancy being present w/in the last five years.&#xD;
&#xD;
          -  Received prior radiotherapy to any portion of the abdominal cavity or pelvis OTHER&#xD;
             THAN for treatment of ovarian, fallopian tube, or primary peritoneal cancer w/in the&#xD;
             last 5 years.&#xD;
&#xD;
          -  Prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of&#xD;
             ovarian, fallopian tube, or primary peritoneal cancer or localized breast cancer w/in&#xD;
             the last 5 years.&#xD;
&#xD;
          -  A history of abdominal or tracheal-esophageal fistula, or gastrointestinal perforation&#xD;
&#xD;
          -  A history of intra-abdominal abcess w/in 6 months of enrollment&#xD;
&#xD;
          -  Serious, uncontrolled, concomitant disorder(s) such as diabetes mellitus&#xD;
&#xD;
          -  Patients w/ clinically significant cardiovascular disease including: uncontrolled&#xD;
             hypertension: systolic &gt; 150 mm Hg/diastolic &gt; 90 mm Hg; unstable angina or who have&#xD;
             had a myocardial infarction w/in the past six months prior to registration; congestive&#xD;
             heart failure; cardiac arrhythmia requiring medication (doesn't include asymptomatic&#xD;
             atrial fibrillation); grade 2 or greater peripheral vascular disease (at least brief&#xD;
             (&lt;24 hours) episodes of ischemia managed non-surgically &amp; w/o permanent deficit.&#xD;
&#xD;
          -  Serious non-healing wound, ulcer, or bone factor.&#xD;
&#xD;
             o Granulating incisions healing by secondary intention w/ no evidence of fascial&#xD;
             dehiscence or infection ARE eligible but require weekly wound examinations.&#xD;
&#xD;
          -  Active bleeding or pathologic conditions that carry high risk of bleeding, such as&#xD;
             known bleeding disorder, coagulopathy, or tumor involving major vessels.&#xD;
&#xD;
          -  History/evidence upon physical examination of CNS disease, including primary brain&#xD;
             tumor, seizures not controlled w/ standard medical therapy, any brain metastases, CVA,&#xD;
             TIA, or subarachnoid hemorrhage w/in 6 months of the first date of treatment on this&#xD;
             study.&#xD;
&#xD;
          -  Central pulmonary metastases/recent hemoptysis (≥1/2 tsp of red blood) w/in 28 days of&#xD;
             registration.&#xD;
&#xD;
               -  Clinically significant proteinuria (i.e. &gt;Grade 1) or UPC ratio above 1.0&#xD;
&#xD;
               -  Suspicion of transmural tumor bowel involvement based on the investigator's&#xD;
                  discretion.&#xD;
&#xD;
          -  Clinical symptoms/signs of gastrointestinal obstruction &amp; require IV hydration &amp;/or&#xD;
             nutrition.&#xD;
&#xD;
          -  Patients taking warfarin are not eligible&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Angeles A Secord, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke Cancer Institute</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Virginia</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Oncology Associates</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>July 10, 2012</study_first_submitted>
  <study_first_submitted_qc>August 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2012</study_first_posted>
  <results_first_submitted>September 7, 2018</results_first_submitted>
  <results_first_submitted_qc>October 13, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">October 16, 2018</results_first_posted>
  <last_update_submitted>October 13, 2018</last_update_submitted>
  <last_update_submitted_qc>October 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 16, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Duke University</investigator_affiliation>
    <investigator_full_name>AA Secord</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Recurrent epithelial ovarian carcinoma</keyword>
  <keyword>Persistent epithelial ovarian carcinoma</keyword>
  <keyword>Bevacizumab resistant epithelial ovarian carcinoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ovarian Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Ovarian Epithelial</mesh_term>
    <mesh_term>Fallopian Tube Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nintedanib</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 16, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/98/NCT01669798/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Patients were enrolled from February of 2013 to July of 2017 at three cancer clinics in North Carolina and Virginia.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>BIBF 1120</title>
          <description>BIBF 1120 will be administered at a daily oral dose of 200 mg BID until disease progression or adverse effects prohibit further therapy.&#xD;
BIBF 1120: PO 200mg BID</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>BIBF 1120</title>
          <description>BIBF 1120 will be administered at a daily oral dose of 200 mg BID until disease progression or adverse effects prohibit further therapy.&#xD;
BIBF 1120: PO 200mg BID</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="27"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </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="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Primary site of tumor</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Ovary</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Peritoneum</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Histologic tumor type</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Adenocarcinoma, Unspecified</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Clear Cell Carcinoma</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other: Poorly Differentiated Adenocarcinoma</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serous Adenocarcinoma</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Platinum based treatment resistant/sensitive</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Platinum Resistant</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platinum Sensitive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Antecedent Bevacizumab (bev) therapy prior to starting trial</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Front-line chemo with bev, plus bev maintenance</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Front-line chemo with bev, without bev maintenance</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Second-line chemo with bev, plus bev maintenance</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Secon-line chemo with bev, without bev maintenance</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Second line single agent bevacizumab</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Third-line chemotherapy plus bevacizumab</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of prior therapy regimens</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>One prior regimen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Two prior regimens</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Three prior regimens</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Four prior regimens</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Patients Who Survive Progression-free</title>
        <description>Measure of Progression Free Survival (PFS) by the percentage of patients who survive progression-free for at least 6 months after initiating study therapy in patients with bevacizumab-resistant, persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.</description>
        <time_frame>6 months</time_frame>
        <population>The analysis was to be based on 27 evaluable patients for the first stage. Subjects were considered evaluable if they completed at least one cycle of study drug. Of the 27 subjects, one was not considered evaluable because they did not receive a full cycle.</population>
        <group_list>
          <group group_id="O1">
            <title>BIBF 1120</title>
            <description>BIBF 1120 will be administered at a daily oral dose of 200 mg BID until disease progression or adverse effects prohibit further therapy.&#xD;
BIBF 1120: PO 200mg BID</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients Who Survive Progression-free</title>
          <description>Measure of Progression Free Survival (PFS) by the percentage of patients who survive progression-free for at least 6 months after initiating study therapy in patients with bevacizumab-resistant, persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.</description>
          <population>The analysis was to be based on 27 evaluable patients for the first stage. Subjects were considered evaluable if they completed at least one cycle of study drug. Of the 27 subjects, one was not considered evaluable because they did not receive a full cycle.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.5" lower_limit="2.5" upper_limit="30.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Objective Tumor Response Via RECIST (Response Evaluation Criteria in Solid Tumors) 1.1</title>
        <description>Evaluating the percentage of patients who have objective tumor response (complete or partial) based on RECIST 1.1 criteria.</description>
        <time_frame>1 year</time_frame>
        <population>Responders are those who achieved a partial response (PR). No subjects achieved a complete response (CR).</population>
        <group_list>
          <group group_id="O1">
            <title>BIBF 1120</title>
            <description>BIBF 1120 will be administered at a daily oral dose of 200 mg BID until disease progression or adverse effects prohibit further therapy.&#xD;
BIBF 1120: PO 200mg BID</description>
          </group>
        </group_list>
        <measure>
          <title>Objective Tumor Response Via RECIST (Response Evaluation Criteria in Solid Tumors) 1.1</title>
          <description>Evaluating the percentage of patients who have objective tumor response (complete or partial) based on RECIST 1.1 criteria.</description>
          <population>Responders are those who achieved a partial response (PR). No subjects achieved a complete response (CR).</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.4" lower_limit="0.9" upper_limit="24.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Progression-Free Survival</title>
        <description>The duration of progression-free survival and overall survival measured in months; Progression-Free Survival (PFS) is defined as the duration of time from study entry to time of progression or death, whichever occurs first.</description>
        <time_frame>Through study completion, on average 2 years</time_frame>
        <population>Analysis stratified results between PFS (Progression Free Survival) and OS (Overall Survival). Confidence interval and results based on Kaplan Meier Estimates.</population>
        <group_list>
          <group group_id="O1">
            <title>BIBF 1120</title>
            <description>BIBF 1120 will be administered at a daily oral dose of 200 mg BID until disease progression or adverse effects prohibit further therapy.&#xD;
BIBF 1120: PO 200mg BID</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Progression-Free Survival</title>
          <description>The duration of progression-free survival and overall survival measured in months; Progression-Free Survival (PFS) is defined as the duration of time from study entry to time of progression or death, whichever occurs first.</description>
          <population>Analysis stratified results between PFS (Progression Free Survival) and OS (Overall Survival). Confidence interval and results based on Kaplan Meier Estimates.</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="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Progression Free Survival (PFS)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8" lower_limit="1.6" upper_limit="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall Survival (OS)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16" lower_limit="8" upper_limit="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Objective Tumor Response Based on GCIG CA-125 Criteria</title>
        <description>The proportion of patients who have objective tumor response (complete or partial) based on Gynaecologic Cancer InterGroup(GCIG) CA-125 criteria which is: &quot;A response according to CA 125 has occurred if there is at least a 50% reduction in CA 125 levels from a pretreatment sample. The response must be confirmed and maintained for at least 28 days.&quot;.</description>
        <time_frame>1 year</time_frame>
        <population>Twenty five subjects were analyzed based on the Gynaecologic Cancer Intergroup response CA125 response criteria. Two subjects data were unavailable.</population>
        <group_list>
          <group group_id="O1">
            <title>BIBF 1120</title>
            <description>BIBF 1120 will be administered at a daily oral dose of 200 mg BID until disease progression or adverse effects prohibit further therapy.&#xD;
BIBF 1120: PO 200mg BID</description>
          </group>
        </group_list>
        <measure>
          <title>Objective Tumor Response Based on GCIG CA-125 Criteria</title>
          <description>The proportion of patients who have objective tumor response (complete or partial) based on Gynaecologic Cancer InterGroup(GCIG) CA-125 criteria which is: &quot;A response according to CA 125 has occurred if there is at least a 50% reduction in CA 125 levels from a pretreatment sample. The response must be confirmed and maintained for at least 28 days.&quot;.</description>
          <population>Twenty five subjects were analyzed based on the Gynaecologic Cancer Intergroup response CA125 response criteria. Two subjects data were unavailable.</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="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adverse Event Frequency and Severity</title>
        <description>To determine frequency and severity of adverse events as assessed using NCI Common Toxicity Criteria version 4.</description>
        <time_frame>1 year</time_frame>
        <population>All adverse events considered possible, probably, or definitely related to study drug. Reported regardless of severity.</population>
        <group_list>
          <group group_id="O1">
            <title>BIBF 1120</title>
            <description>BIBF 1120 will be administered at a daily oral dose of 200 mg BID until disease progression or adverse effects prohibit further therapy.&#xD;
BIBF 1120: PO 200mg BID</description>
          </group>
        </group_list>
        <measure>
          <title>Adverse Event Frequency and Severity</title>
          <description>To determine frequency and severity of adverse events as assessed using NCI Common Toxicity Criteria version 4.</description>
          <population>All adverse events considered possible, probably, or definitely related to study drug. Reported regardless of severity.</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="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Anemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sinus tachycardia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tinnitus</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abdominal pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bloating</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diarrhea</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dry mouth</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Constipation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dyspepsia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Gastroesophageal reflux disease</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nausea</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vomiting</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chills</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Edema limbs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fatigue</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-cardiac chest pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alanine aminotransferase increased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alkaline phosphatase increased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Aspartate aminotransferase increased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine increased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophil count decreased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelet count decreased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Weight loss</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anorexia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypoalbuminemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypocalcemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypomagnesemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hyponatremia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Arthralgia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Arthritis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Back Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bone pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain in extremity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dysgeusia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hematuria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Proteinuria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urinary incontinence</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vaginal dryness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vaginal pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Atelectasis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dyspnea</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pleural effusion</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Wheezing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rash maculo-papular</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypertension</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intermittent leg cramps</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bilateral neuropathy, hands and feet</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Concentration of Select Growth Factors Reported Measured in Picograms Per Milliliter as a Function of Treatment Response</title>
        <description>Correlating baseline and on treatment levels of additional growth factors measured in picograms per milliliter that may be co- or counter- regulated with VEGF with response to treatment</description>
        <time_frame>1 year</time_frame>
        <population>Biomarker levels measured and stratified into two groups: those who experienced either Partial Response (PR) or Stable Disease (SD); and those who experienced Progressive Disease (PD). Data was not collected for one subject.</population>
        <group_list>
          <group group_id="O1">
            <title>BIBF 1120</title>
            <description>BIBF 1120 will be administered at a daily oral dose of 200 mg BID until disease progression or adverse effects prohibit further therapy.&#xD;
BIBF 1120: PO 200mg BID</description>
          </group>
        </group_list>
        <measure>
          <title>Concentration of Select Growth Factors Reported Measured in Picograms Per Milliliter as a Function of Treatment Response</title>
          <description>Correlating baseline and on treatment levels of additional growth factors measured in picograms per milliliter that may be co- or counter- regulated with VEGF with response to treatment</description>
          <population>Biomarker levels measured and stratified into two groups: those who experienced either Partial Response (PR) or Stable Disease (SD); and those who experienced Progressive Disease (PD). Data was not collected for one subject.</population>
          <units>picograms per milliliter</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CD73: Partial Response or Stable Disease</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" lower_limit="1.8" upper_limit="3.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD73: Progressive Disease</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8" lower_limit="2.6" upper_limit="5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HGF: Partial Response or Stable Disease</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="130.1" lower_limit="78.3" upper_limit="188.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HGF: Progressive Disease</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="191.0" lower_limit="72.1" upper_limit="517.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-6: Partial Response or Stable Disease</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.2" lower_limit="8.9" upper_limit="28.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-6: Progressive Disease</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.6" lower_limit="16.5" upper_limit="50.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PDGF-AA: Partial Response or Stable Disease</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.5" lower_limit="27.7" upper_limit="347.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PDGF-AA: Progressive Disease</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="233.9" lower_limit="47.1" upper_limit="419.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PDGF-BB: Partial Response or Stable Disease</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="184.7" lower_limit="26.7" upper_limit="325.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PDGF-BB (pg/ml): PD</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="396.4" lower_limit="91.1" upper_limit="769.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PIGF: Partial Response or Stable Disease</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.4" lower_limit="21.5" upper_limit="27.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PIGF: Progressive Disease</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.3" lower_limit="14.2" upper_limit="30.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SDF-1: Partial Response or Stable Disease</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1968.6" lower_limit="1453.7" upper_limit="3021.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SDF-1: Progressive Disease</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2121.9" lower_limit="1199.4" upper_limit="3360.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TGFBeta-R3: Partial Respone or Stable Disease</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.6" lower_limit="32.8" upper_limit="71.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TGFBeta-R3: Progressive Disease</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.5" lower_limit="45.4" upper_limit="57.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ang2: Partial Response or Stable Disease</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="261.1" lower_limit="141.6" upper_limit="456.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ang2: Progressive Disease</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="189.5" lower_limit="146.7" upper_limit="222.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BMP-9: Partial Response or Stable Disease</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.0" lower_limit="39.0" upper_limit="62.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BMP-9: Progressive Disease</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.9" lower_limit="36.2" upper_limit="48.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Coagulation and Endothelial Cell Activation Markers</title>
        <description>To measure baseline and on treatment levels of additional growth factors that may be co- or counter- regulated with VEGF and correlate with response to treatment.</description>
        <time_frame>1 year</time_frame>
        <population>We initially planned to measure baseline and on treatment levels of coagulation and endothelial cell activation markers that may predict for thrombotic or bleeding risks related to treatment. These markers are best analyzed in citrated plasma and funding was not available for tube collection and analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>BIBF 1120</title>
            <description>BIBF 1120 will be administered at a daily oral dose of 200 mg BID until disease progression or adverse effects prohibit further therapy.&#xD;
BIBF 1120: PO 200mg BID</description>
          </group>
        </group_list>
        <measure>
          <title>Coagulation and Endothelial Cell Activation Markers</title>
          <description>To measure baseline and on treatment levels of additional growth factors that may be co- or counter- regulated with VEGF and correlate with response to treatment.</description>
          <population>We initially planned to measure baseline and on treatment levels of coagulation and endothelial cell activation markers that may predict for thrombotic or bleeding risks related to treatment. These markers are best analyzed in citrated plasma and funding was not available for tube collection and analysis.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>VEGF Levels Correlated With Treatment Outcome</title>
        <description>Baseline levels of VEGF were correlated with treatment outcome. Results are stratified in groups: &quot;Partial Response (PR) or Stable Disease (SD)&quot; and &quot;Progressive Disease (PD)&quot;</description>
        <time_frame>1 year</time_frame>
        <population>VEGF levels measured and stratified into two groups: those who experienced either Partial Response (PR) or Stable Disease (SD); and those who experienced Progressive Disease (PD). Data was not collected for one subject</population>
        <group_list>
          <group group_id="O1">
            <title>BIBF 1120</title>
            <description>BIBF 1120 will be administered at a daily oral dose of 200 mg BID until disease progression or adverse effects prohibit further therapy.&#xD;
BIBF 1120: PO 200mg BID</description>
          </group>
        </group_list>
        <measure>
          <title>VEGF Levels Correlated With Treatment Outcome</title>
          <description>Baseline levels of VEGF were correlated with treatment outcome. Results are stratified in groups: &quot;Partial Response (PR) or Stable Disease (SD)&quot; and &quot;Progressive Disease (PD)&quot;</description>
          <population>VEGF levels measured and stratified into two groups: those who experienced either Partial Response (PR) or Stable Disease (SD); and those who experienced Progressive Disease (PD). Data was not collected for one subject</population>
          <units>picograms per milliliter</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Partial Response or Stable Disease</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1405" lower_limit="958" upper_limit="1580"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Progressive Disease</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1033" lower_limit="698" upper_limit="1199"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Concentration of Select Growth Factors Measured in Nanograms Per Milliliter Reported as a Function of Treatment Response</title>
        <description>Correlating baseline and on treatment levels of additional growth factors measured in nanograms per milliliter that may be co- or counter- regulated with VEGF with response to treatment</description>
        <time_frame>1 year</time_frame>
        <population>Biomarker levels measured and stratified into two groups: those who experienced either Partial Response (PR) or Stable Disease (SD); and those who experienced Progressive Disease (PD). Data was not collected for one subject.</population>
        <group_list>
          <group group_id="O1">
            <title>BIBF 1120</title>
            <description>BIBF 1120 will be administered at a daily oral dose of 200 mg BID until disease progression or adverse effects prohibit further therapy.&#xD;
BIBF 1120: PO 200mg BID</description>
          </group>
        </group_list>
        <measure>
          <title>Concentration of Select Growth Factors Measured in Nanograms Per Milliliter Reported as a Function of Treatment Response</title>
          <description>Correlating baseline and on treatment levels of additional growth factors measured in nanograms per milliliter that may be co- or counter- regulated with VEGF with response to treatment</description>
          <population>Biomarker levels measured and stratified into two groups: those who experienced either Partial Response (PR) or Stable Disease (SD); and those who experienced Progressive Disease (PD). Data was not collected for one subject.</population>
          <units>nanograms per milliliter</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ICAM-1: Partial Response or Stable Disease</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="635.1" lower_limit="584.0" upper_limit="688.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ICAM-1: Progressive Disease</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="686.8" lower_limit="589.0" upper_limit="951.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>OPN: Partial Response or Stable Disease</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="643.0" lower_limit="470.0" upper_limit="887.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>OPN: Progressive Disease</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="923.0" lower_limit="530.0" upper_limit="1349.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TGF-Beta1: Partial Response or Stable Disease</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="122.5" lower_limit="93.4" upper_limit="134.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TGF-Beta1: Progressive Disease</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.3" lower_limit="75.8" upper_limit="118.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TGF-Beta2: Partial Response or Stable Disease</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.0" lower_limit="14.4" upper_limit="34.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TGF-Beta2: Progressive Disease</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.4" lower_limit="14.4" upper_limit="57.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TIMP-1: Partial Response or Stable Disease</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.5" lower_limit="72.2" upper_limit="108.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TIMP-1: Progressive Disease</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="116.4" lower_limit="88.2" upper_limit="141.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TSP-2: Partial Response or Stable Disease</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.1" lower_limit="77.6" upper_limit="113.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TSP-2: Progressive Disease</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="104.9" lower_limit="91.5" upper_limit="169.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Concentration of VCAM-1 Reported as a Function of Treatment Response</title>
        <description>Correlating baseline and on treatment levels of VCAM-1 measured in micrograms per milliliter that may be co- or counter- regulated with VEGF with response to treatment</description>
        <time_frame>1 year</time_frame>
        <population>Biomarker levels measured and stratified into two groups: those who experienced either Partial Response (PR) or Stable Disease (SD); and those who experienced Progressive Disease (PD). Data was not collected for one subject.</population>
        <group_list>
          <group group_id="O1">
            <title>BIBF 1120</title>
            <description>BIBF 1120 will be administered at a daily oral dose of 200 mg BID until disease progression or adverse effects prohibit further therapy.&#xD;
BIBF 1120: PO 200mg BID</description>
          </group>
        </group_list>
        <measure>
          <title>Concentration of VCAM-1 Reported as a Function of Treatment Response</title>
          <description>Correlating baseline and on treatment levels of VCAM-1 measured in micrograms per milliliter that may be co- or counter- regulated with VEGF with response to treatment</description>
          <population>Biomarker levels measured and stratified into two groups: those who experienced either Partial Response (PR) or Stable Disease (SD); and those who experienced Progressive Disease (PD). Data was not collected for one subject.</population>
          <units>micrograms per milliliter</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>VCAM-1: Partial Response or Stable Disease</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2" lower_limit="1.8" upper_limit="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>VCAM-1: Progressive Disease</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3" lower_limit="1.6" upper_limit="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>BIBF 1120</title>
          <description>BIBF 1120 will be administered at a daily oral dose of 200 mg BID until disease progression or adverse effects prohibit further therapy.&#xD;
BIBF 1120: PO 200mg BID</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>CTCAE (4.0)</default_vocab>
        <default_assessment>Non-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="22" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Kidney Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyponatremia</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>3</frequency_threshold>
        <default_vocab>CTCAE (4.0)</default_vocab>
        <default_assessment>Non-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="27" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Sinus tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Tinnitus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Endocrine disorders - Other, specify</sub_title>
                <description>Cold intolerance</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Bloating</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Gastroesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Edema limbs</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infections and infestations - Other, specify</sub_title>
                <description>One event: Ear infection One event: Fever blisters</description>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Tooth infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Upper respiratory infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Alkaline phosphatase increased</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Creatinine increased</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Investigations - Other, specify</sub_title>
                <description>Alanine transaminase</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Weight loss</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>White blood cell decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Anorexia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Hyperglycemia</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Hyperkalemia</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Hypoalbuminemia</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Hypocalcemia</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Hypokalemia</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Hypomagnesemia</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Hyponatremia</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Aarthralgia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Chest wall pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Musculoskeletal and connective tissue disorder- Other, specify</sub_title>
                <description>One event: Ganglion cyst One event: Intermittent leg cramps One event: Arthralgia</description>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Nervous system disorders - Other, specify</sub_title>
                <description>Bilateraly neuropathy, hands and feet</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Hematuria</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Proteinuria</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Renal and urinary disorders - Other, specify</sub_title>
                <description>One event: Pelvic prolapse</description>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Urinary frequency</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Urinary incontinence</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Urinary tract obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Vaginal dryness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Vaginal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Atelectasis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Pulmonary edema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Wheezing</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Skin ulceration</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Angeles Alvarez Secord</name_or_title>
      <organization>Duke University Medical Center</organization>
      <phone>919-684-3765</phone>
      <email>secor002@mc.duke.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/NCT01669798
org study id: Pro00033060
nct id: NCT01669798
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
The main purpose of this study is to see if BIBF 1120 can increase the number of women with
      bevacizumab resistant, persistent, or recurrent epithelial ovarian cancer who do not progress
      for at least six months.
Ovarian cancer patients with platinum-resistant and refractory disease have the lowest
      response rates to relapse chemotherapy: various chemotherapeutic agents, such as paclitaxel,
      liposomal doxorubicin, topotecan, docetaxel, platinum, etoposide, ifosfamide, gemcitabine,
      and vinorelbine are available but result in response rates of 7-40%. Unfortunately, relapse
      therapy is not curative and treatment is only palliative. Recently two phase II trials
      demonstrated that anti-angiogenic therapy with bevacizumab alone or in combination with
      chemotherapy in women with recurrent disease had response rates ranging from 16-24% with an
      acceptable toxicity profile. However, resistance can develop to VEGF inhibition. Therefore
      other novel anti-angiogenic agents, such as BIBF 1120, should be evaluated in the treatment
      of ovarian cancer.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Patients Who Survive Progression-free
time frame: 6 months
description: Measure of Progression Free Survival (PFS) by the percentage of patients who survive progression-free for at least 6 months after initiating study therapy in patients with bevacizumab-resistant, persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
measure: Objective Tumor Response Via RECIST (Response Evaluation Criteria in Solid Tumors) 1.1
time frame: 1 year
description: Evaluating the percentage of patients who have objective tumor response (complete or partial) based on RECIST 1.1 criteria.
measure: Duration of Progression-Free Survival
time frame: Through study completion, on average 2 years
description: The duration of progression-free survival and overall survival measured in months; Progression-Free Survival (PFS) is defined as the duration of time from study entry to time of progression or death, whichever occurs first.
measure: Objective Tumor Response Based on GCIG CA-125 Criteria
time frame: 1 year
description: The proportion of patients who have objective tumor response (complete or partial) based on Gynaecologic Cancer InterGroup(GCIG) CA-125 criteria which is: "A response according to CA 125 has occurred if there is at least a 50% reduction in CA 125 levels from a pretreatment sample. The response must be confirmed and maintained for at least 28 days.".
measure: Adverse Event Frequency and Severity
time frame: 1 year
description: To determine frequency and severity of adverse events as assessed using NCI Common Toxicity Criteria version 4.
measure: Concentration of Select Growth Factors Reported Measured in Picograms Per Milliliter as a Function of Treatment Response
time frame: 1 year
description: Correlating baseline and on treatment levels of additional growth factors measured in picograms per milliliter that may be co- or counter- regulated with VEGF with response to treatment
measure: Coagulation and Endothelial Cell Activation Markers
time frame: 1 year
description: To measure baseline and on treatment levels of additional growth factors that may be co- or counter- regulated with VEGF and correlate with response to treatment.
measure: VEGF Levels Correlated With Treatment Outcome
time frame: 1 year
description: Baseline levels of VEGF were correlated with treatment outcome. Results are stratified in groups: "Partial Response (PR) or Stable Disease (SD)" and "Progressive Disease (PD)"
measure: Concentration of Select Growth Factors Measured in Nanograms Per Milliliter Reported as a Function of Treatment Response
time frame: 1 year
description: Correlating baseline and on treatment levels of additional growth factors measured in nanograms per milliliter that may be co- or counter- regulated with VEGF with response to treatment
measure: Concentration of VCAM-1 Reported as a Function of Treatment Response
time frame: 1 year
description: Correlating baseline and on treatment levels of VCAM-1 measured in micrograms per milliliter that may be co- or counter- regulated with VEGF with response to treatment
arm group label: BIBF 1120
arm group type: Experimental
description: BIBF 1120 will be administered at a daily oral dose of 200 mg BID until disease progression or adverse effects prohibit further therapy.
intervention type: Drug
intervention name: BIBF 1120
description: PO 200mg BID
arm group label: BIBF 1120
other name: Vargatef™
other name: Nintedanib
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Angeles A Secord, MD
role: Principal Investigator
affiliation: Duke University
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Duke University
investigator full name: AA Secord
investigator title: Associate Professor
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial
mesh term: Fallopian Tube Neoplasms
mesh term: Nintedanib
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 