<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/NCT02212015</url>
  </required_header>
  <id_info>
    <org_study_id>GISG-06</org_study_id>
    <nct_id>NCT02212015</nct_id>
  </id_info>
  <brief_title>Evaluation of Votrient in Angiosarcoma</brief_title>
  <acronym>EVA</acronym>
  <official_title>Single-arm, Multicenter, Open Label Phase II Trial to Evaluate the Efficacy of Pazopanib in Combination With Paclitaxel in Advanced and Relapsed Angiosarcoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Heidelberg University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Universitätsmedizin Mannheim</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Helios Klinikum Berlin-Buch</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital Dresden</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Universitätsklinikum Hamburg-Eppendorf</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital, Essen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hannover Medical School</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Klinikum der Universitaet Muenchen, Grosshadern</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Medical University of Graz</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Medical University Innsbruck</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Novartis Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Heidelberg University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Open-label phase II trial investigating the efficacy and safety of the investigational&#xD;
      combination of pazopanib and paclitaxel.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Open-label phase II trial investigating the efficacy and safety of the investigational&#xD;
      combination of pazopanib and paclitaxel.This multi-center, open-label, prospective, single&#xD;
      arm phase II study was designed to evaluate the clinical efficacy and safety of the&#xD;
      experimental combination of pazopanib with paclitaxel in the treatment of patients with&#xD;
      advanced or metastatic angiosarcoma.The safety evaluations (physical examination, laboratory&#xD;
      checks as defined in protocol, toxicity/adverse event assessment according Eastern&#xD;
      Cooperative Oncology Group version 4.0) are scheduled every cycle at day 1, 8, 15 and 29 (=&#xD;
      day 1 of the next cycle).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Due to interim analysis' results and definitions fixed in protocol&#xD;
  </why_stopped>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">July 1, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</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>Rate of Progression-free Survival</measure>
    <time_frame>6 Month</time_frame>
    <description>The diagnosis of progession is based on tumor measurements assessed 182 days +/- 32 days after start of treatment (with imaging date as reference date) and according to the RECIST Version 1.1 criteria based on a predefined set of target lesions and non-target lesions.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of Progression-free Survival, Subgroup 1 Analysis</measure>
    <time_frame>6 months</time_frame>
    <description>Rate of progression-free survival for Subgroup 1 categorizing the 12 participants who showed PFS after 6 months into cutaneous angiosarcoma versus visceral angiosarcoma The diagnosis of progession is based on tumor measurements assessed 182 days +/- 32 days after start of treatment (with imaging date as reference date) and according to the RECIST Version 1.1 criteria based on a predefined set of target lesions and non-target lesions.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of Progression-free Survival, Subgroup 2 Analysis</measure>
    <time_frame>6 months</time_frame>
    <description>Rate of progression-free survival for Subgroup 1 categorizing the 12 participants who showed PFS after 6 months into primary angiosarcoma versus secondary angiosarcoma.&#xD;
The diagnosis of progession is based on tumor measurements assessed 182 days +/- 32 days after start of treatment (with imaging date as reference date) and according to the RECIST Version 1.1 criteria based on a predefined set of target lesions and non-target lesions.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>from start of treatment until death within study's actual observation time for OS (22 months).</time_frame>
    <description>Survival time of patient from start of treatment until death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival, Subgroup 1 Analysis</measure>
    <time_frame>from start of treatment until death within study's actual observation time for OS (22 months)</time_frame>
    <description>Survival time of patients from start of treatment until death, Subgroup 1 categorizing 26 overall participants into 18 cutaneous angiosarcoma versus 8 visceral angiosarcomas</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival, Subgroup 2 Analysis</measure>
    <time_frame>from start of treatment until death within study's actual observation time for OS (22 months)</time_frame>
    <description>Survival time of patients from start of treatment until death, Subgroup 2 categorizing 26 overall participants into 13 primary cutaneous angiosarcoma versus 13 secondary angiosarcomas</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response Rate (RR)</measure>
    <time_frame>determined every 8 weeks during first 6 month then every 12 weeks in follow-up period until progression or death or end of overall study observation period (22 months), then evaluated as BOR</time_frame>
    <description>Measurable skin lesions will be evaluated clinically and documented photographically, all other target lesions will be evaluated radiologically by CT or MRI according to RECIST Version 1.1.&#xD;
RR is given as 'Best overall response&quot; BOR&quot; defined as CR (complete remission), PR (partial) remission), SD (stable diesease) and PD (progressive disease) or NE (not evaluated) and provided by absolute and relative frequencies</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response Rate (RR), Subgroup1 Analysis</measure>
    <time_frame>determined every 8 weeks during first 6 month then every 12 weeks in follow-up period until progression or death or end of overall study observation period (22 months), then evaluated as BOR</time_frame>
    <description>Measurable skin lesions will be evaluated clinically and documented photographically, all other target lesions will be evaluated radiologically by CT or MRI according to RECIST Version 1.1.&#xD;
RR is given as 'Best overall response&quot; BOR&quot; defined as CR (complete remission), PR (partial) remission), SD (stable diesease) and PD (progressive disease) or NE (not evaluated) and provided by absolute and relative frequencies for Subgroup 1 which is the analysis of cutaneous angiosarcoma versus visceral angiosarcoma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response Rate (RR), Subgroup 2 Analysis</measure>
    <time_frame>determined every 8 weeks during first 6 month then every 12 weeks in follow-up period until progression or death or end of overall study observation period (22 months), then evaluated as BOR</time_frame>
    <description>Measurable skin lesions will be evaluated clinically and documented photographically, all other target lesions will be evaluated radiologically by CT or MRI according to RECIST Version 1.1.&#xD;
RR is given as 'Best overall response&quot; BOR&quot; defined as CR (complete remission), PR (partial) remission), SD (stable diesease) and PD (progressive disease) or NE (not evaluated) and provided by absolute and relative frequencies for Subgroup 2 which is the analysis of primary angiosarcoma versus secondary angiosarcoma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events and Serious Adverse Events</measure>
    <time_frame>30 days after EOS of last patient or end of overall study observation period (22 months)</time_frame>
    <description>Number of patients in which adverse events occur during treatment according to Common Toxicity Criteria for Adverse Effects, Version 4.0</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Angiosarcoma</condition>
  <arm_group>
    <arm_group_label>Pazopanib + Paclitaxel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Paclitaxel administered every 28 days at day 1, day 8 and day 15 as a 2h intravenous infusion in a dose of 70mg/m2 in combination with pazopanib in a daily oral dose of 800mg (2x400mg)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pazopanib + Paclitaxel</intervention_name>
    <description>pazopanib in combination with paclitaxel in the treatment of patients with advanced or metastatic angiosarcoma.</description>
    <arm_group_label>Pazopanib + Paclitaxel</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects must provide written informed consent prior to performance of study-specific&#xD;
             procedures or assessments and must be willing to comply with treatment and follow-up.&#xD;
             Note: Procedures conducted as part of the subject's routine clinical management (e.g.,&#xD;
             blood count, imaging studies) and obtained prior to signing informed consent may be&#xD;
             utilized for screening or baseline purposes provided these procedures are conducted as&#xD;
             specified in the protocol.&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Life expectancy &gt; 3 months&#xD;
&#xD;
          -  Ability to swallow tablets&#xD;
&#xD;
          -  Histological confirmed angiosarcoma, primary and secondary angiosarcoma (e.g.&#xD;
             radiation-induced or angiosarcoma in chronical lymphedema) are eligible.&#xD;
&#xD;
          -  Tumor must be locally advanced (unresectable) or metastatic. A progression must be&#xD;
             documented within a 6-month period prior to screening.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group performance status ≤ 2&#xD;
&#xD;
          -  At least one measurable skin lesion or one measurable radiological (CT or MRI) target&#xD;
             lesion (RECIST 1.1)&#xD;
&#xD;
          -  Adequate organ system function as described in protocol&#xD;
&#xD;
          -  A female is eligible to enter and participate in this study if she is either of non&#xD;
             childbearing potential (defined in protocol) or childbearing potential with negative&#xD;
             pregnancy test within 2 weeks prior to the first dose of study drug and agrees to use&#xD;
             adequate contraception (as defined in protocol) during the study and for 30 days after&#xD;
             the last dose of study drug.&#xD;
&#xD;
          -  All sexually active male patients must agree to use adequate methods of birth control&#xD;
             (see protocol) throughout the study and for 30 days after the last dose of study drug.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who need an active treatment for another malignant disease other than&#xD;
             angiosarcoma&#xD;
&#xD;
          -  Prior treatment with taxane within the last 12 months before study entry&#xD;
&#xD;
          -  History or clinical evidence of central nervous system (CNS) metastases or&#xD;
             leptomeningeal sarcomatosis.(see protocol)&#xD;
&#xD;
          -  Clinically significant gastrointestinal abnormalities that may increase the risk for&#xD;
             gastrointestinal bleeding (see protocol)&#xD;
&#xD;
          -  Clinically significant gastrointestinal abnormalities that may affect absorption of&#xD;
             investigational product (see protocol)&#xD;
&#xD;
          -  Presence of uncontrolled infection&#xD;
&#xD;
          -  QT prolongation interval (QTc) &gt; 480 msec.&#xD;
&#xD;
          -  Clinically significant cardiovascular disorders within the past 6 months&#xD;
&#xD;
          -  Major surgery or trauma within 28 days prior to first dose of investigational product&#xD;
             and/or presence of any non-healing wound, fracture, or ulcer&#xD;
&#xD;
          -  Poorly controlled hypertension (see protocol)&#xD;
&#xD;
          -  Evidence of active bleeding or bleeding diathesis&#xD;
&#xD;
          -  Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels&#xD;
&#xD;
          -  Uncontrolled seizures, disorders of the CNS or psychiatric disorders which may put&#xD;
             patient safety at risk, prevent giving informed consent or impact the patient's&#xD;
             compliance with the use of study medication&#xD;
&#xD;
          -  Women who are pregnant or breast feeding&#xD;
&#xD;
          -  Patients who are not able or not willing to interrupt the intake of medications that&#xD;
             are not allowed according to study protocol for at least 14 days before start of study&#xD;
             medication and for the whole study period&#xD;
&#xD;
          -  Chemotherapy or radiotherapy within 14 days before start of study medication&#xD;
&#xD;
          -  Any ongoing toxicity from prior anti-cancer therapy that is &gt; grade 1 and/or that is&#xD;
             progressing in severity, except alopecia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter Hohenberger, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitätsmedizin Mannheim / Heidelberg University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universitätsklinik Graz</name>
      <address>
        <city>Graz</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinik Wien</name>
      <address>
        <city>Wien</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Helios-Klinikum Bad Saarow</name>
      <address>
        <city>Bad Saarow</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Helios Klinikum Berlin-Buch</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Carl Gustav Carus</name>
      <address>
        <city>Dresden</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Essen</name>
      <address>
        <city>Essen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Hamburg-Eppendorf</name>
      <address>
        <city>Hamburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Hochschule Hannover</name>
      <address>
        <city>Hannover</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Medical Center</name>
      <address>
        <city>Mannheim</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum der Universität München Campus Großhadern</name>
      <address>
        <city>München</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>http://www.gisg.de</url>
    <description>German Interdisciplinary Sarcoma Group</description>
  </link>
  <link>
    <url>http://www.sarcoma.at</url>
    <description>Sarcoma Platform Austria</description>
  </link>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>July 29, 2014</study_first_submitted>
  <study_first_submitted_qc>August 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2014</study_first_posted>
  <results_first_submitted>November 4, 2021</results_first_submitted>
  <results_first_submitted_qc>January 21, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">March 22, 2022</results_first_posted>
  <last_update_submitted>January 21, 2022</last_update_submitted>
  <last_update_submitted_qc>January 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universitätsmedizin Mannheim</investigator_affiliation>
    <investigator_full_name>Peter Hohenberger</investigator_full_name>
    <investigator_title>Prof. Dr. med.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemangiosarcoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 28, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/15/NCT02212015/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 3, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/15/NCT02212015/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Pazopanib + Paclitaxel</title>
          <description>Paclitaxel administered every 28 days at day 1, day 8 and day 15 as a 2h intravenous infusion in a dose of 70mg/m2 in combination with pazopanib in a daily oral dose of 800mg (2x400mg) in the treatment of patients with advanced or metastatic angiosarcoma.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Pazopanib + Paclitaxel</title>
          <description>Paclitaxel administered every 28 days at day 1, day 8 and day 15 as a 2h intravenous infusion in a dose of 70mg/m2 in combination with pazopanib in a daily oral dose of 800mg (2x400mg)&#xD;
Pazopanib + Paclitaxel: pazopanib in combination with paclitaxel in the treatment of patients with advanced or metastatic angiosarcoma.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="26"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="57.8" spread="13.5"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Subgroup 1 for Analyses</title>
          <description>Overall number of 26 participants were additionally subgrouped for outcome analyses (primary and secondary endpoint analyses) into cutaneous angiosarcomas versus visceral angiosarcomas</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>cutaneous angiosarcoma</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>visceral angiosarcoma</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Subgroup 2 for Analyses</title>
          <description>Overall number of 26 participants were additionally subgrouped for outcome analyses (primary and secondary endpoint analyses) into primary angiosarcomas versus secondary angiosarcomas</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>primary angiosarcoma</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>secondary angiosarcoma</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Rate of Progression-free Survival</title>
        <description>The diagnosis of progession is based on tumor measurements assessed 182 days +/- 32 days after start of treatment (with imaging date as reference date) and according to the RECIST Version 1.1 criteria based on a predefined set of target lesions and non-target lesions.</description>
        <time_frame>6 Month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pazopanib + Paclitaxel</title>
            <description>Paclitaxel i.v. infusion over 6 cycles, administered on day 1, day 8, day 15 of every cycle with a dosage of 70mg/m2 in combination with Pazopanib taken orally with a dosage of 800mg daily/once per day&#xD;
Pazopanib + Paclitaxel: pazopanib in combination with paclitaxel in the treatment of patients with advanced or metastatic angiosarcoma.</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Progression-free Survival</title>
          <description>The diagnosis of progession is based on tumor measurements assessed 182 days +/- 32 days after start of treatment (with imaging date as reference date) and according to the RECIST Version 1.1 criteria based on a predefined set of target lesions and non-target lesions.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Question is, if 6 months progression free survival rate (PFS-R) denoted by pPFS is higher than 35%. Test hypothesis is thus formulated as: H0: pPFS ≤0.35 versus H1: pPFS ≥0.35. This hypothesis is tested at the one-side significance level of 0.05. A 6 months PFS-R of 0.55 of cases or more is considered as clinically relevant success rate. The design is chosen such that rates of 0.55 or higher can be detected with a power of at least 0.8.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Rate</param_type>
            <param_value>0.46</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Rate of Progression-free Survival, Subgroup 1 Analysis</title>
        <description>Rate of progression-free survival for Subgroup 1 categorizing the 12 participants who showed PFS after 6 months into cutaneous angiosarcoma versus visceral angiosarcoma The diagnosis of progession is based on tumor measurements assessed 182 days +/- 32 days after start of treatment (with imaging date as reference date) and according to the RECIST Version 1.1 criteria based on a predefined set of target lesions and non-target lesions.</description>
        <time_frame>6 months</time_frame>
        <population>Subgroup 1 (categorizing total number of 12 participants showing PFR survival after 6 months into cutaneous AS versus visceral AS)</population>
        <group_list>
          <group group_id="O1">
            <title>Pazopanib + Paclitaxel</title>
            <description>Paclitaxel i.v. infusion over 6 cycles, administered on day 1, day 8, day 15 of every cycle with a dosage of 70mg/m2 in combination with Pazopanib taken orally with a dosage of 800mg daily/once per day in the treatment of patients with advanced or metastatic angiosarcoma.</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Progression-free Survival, Subgroup 1 Analysis</title>
          <description>Rate of progression-free survival for Subgroup 1 categorizing the 12 participants who showed PFS after 6 months into cutaneous angiosarcoma versus visceral angiosarcoma The diagnosis of progession is based on tumor measurements assessed 182 days +/- 32 days after start of treatment (with imaging date as reference date) and according to the RECIST Version 1.1 criteria based on a predefined set of target lesions and non-target lesions.</description>
          <population>Subgroup 1 (categorizing total number of 12 participants showing PFR survival after 6 months into cutaneous AS versus visceral AS)</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="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>cutaneous angiosarcoma</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>visceral angiosarcoma</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Rate difference</param_type>
            <param_value>0.486</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Rate of Progression-free Survival, Subgroup 2 Analysis</title>
        <description>Rate of progression-free survival for Subgroup 1 categorizing the 12 participants who showed PFS after 6 months into primary angiosarcoma versus secondary angiosarcoma.&#xD;
The diagnosis of progession is based on tumor measurements assessed 182 days +/- 32 days after start of treatment (with imaging date as reference date) and according to the RECIST Version 1.1 criteria based on a predefined set of target lesions and non-target lesions.</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pazopanib + Paclitaxel</title>
            <description>Paclitaxel i.v. infusion over 6 cycles, administered on day 1, day 8, day 15 of every cycle with a dosage of 70mg/m2 in combination with Pazopanib taken orally with a dosage of 800mg daily/once per day in the treatment of patients with advanced or metastatic angiosarcoma.</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Progression-free Survival, Subgroup 2 Analysis</title>
          <description>Rate of progression-free survival for Subgroup 1 categorizing the 12 participants who showed PFS after 6 months into primary angiosarcoma versus secondary angiosarcoma.&#xD;
The diagnosis of progession is based on tumor measurements assessed 182 days +/- 32 days after start of treatment (with imaging date as reference date) and according to the RECIST Version 1.1 criteria based on a predefined set of target lesions and non-target lesions.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>primary angiosarcoma</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>secondary angiosarcoma</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Rate difference</param_type>
            <param_value>0</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival</title>
        <description>Survival time of patient from start of treatment until death</description>
        <time_frame>from start of treatment until death within study's actual observation time for OS (22 months).</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pazopanib + Paclitaxel</title>
            <description>Paclitaxel administered every 28 days at day 1, day 8 and day 15 as a 2h intravenous infusion in a dose of 70mg/m2 in combination with pazopanib in a daily oral dose of 800mg (2x400mg)&#xD;
Pazopanib + Paclitaxel: pazopanib in combination with paclitaxel in the treatment of patients with advanced or metastatic angiosarcoma.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival</title>
          <description>Survival time of patient from start of treatment until death</description>
          <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="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.6" lower_limit="20.5" upper_limit="NA">The upper bound of the 95% CI could not be estimated, because of too low number of events resulting in the curve representing the upper limit of confidence interval lying above 0.5.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>The analysis of secondary endpoints is of descriptive nature and generally consists of summary statistics and interval estimation.&#xD;
Overall survival (OS) was defined as the time of start of treatment until death (event status=1) or last contact (censoring, event status=0). OS was analyzed using Kaplan-Meier curves. Median survival time is provided alonsgside two-sided 95% confidence interval (CI), if possible.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Median</param_type>
            <param_value>21.6</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival, Subgroup 1 Analysis</title>
        <description>Survival time of patients from start of treatment until death, Subgroup 1 categorizing 26 overall participants into 18 cutaneous angiosarcoma versus 8 visceral angiosarcomas</description>
        <time_frame>from start of treatment until death within study's actual observation time for OS (22 months)</time_frame>
        <population>Overall number of participants analyzed is 26. Thereof, 18 show cutaneous angiosarcoma, and 8 show cutaneos angiosarcoma.</population>
        <group_list>
          <group group_id="O1">
            <title>Pazopanib + Paclitaxel</title>
            <description>Paclitaxel i.v. infusion over 6 cycles, administered on day 1, day 8, day 15 of every cycle with a dosage of 70mg/m2 in combination with Pazopanib taken orally with a dosage of 800mg daily/once per day in the treatment of patients with advanced or metastatic angiosarcoma.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival, Subgroup 1 Analysis</title>
          <description>Survival time of patients from start of treatment until death, Subgroup 1 categorizing 26 overall participants into 18 cutaneous angiosarcoma versus 8 visceral angiosarcomas</description>
          <population>Overall number of participants analyzed is 26. Thereof, 18 show cutaneous angiosarcoma, and 8 show cutaneos angiosarcoma.</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="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>cutaneous angiosarcoma</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.6" lower_limit="10.0" upper_limit="21.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>visceral angiosaroma</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.5" lower_limit="2.8" upper_limit="NA">The upper bound of the 95% CI could not be estimated, because of too low number of events resulting in the curve representing the upper limit of confidence interval lying above 0.5.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>The analysis of secondary endpoints is of descriptive nature and generally consists of summary statistics and interval estimation.&#xD;
Overall survival (OS) for subgroup 1 was defined as the time of start of treatment until death (event status=1) or last contact (censoring, event status=0). OS was analyzed using Kaplan-Meier curves. Median survival time is provided alonsgside two-sided 95% confidence interval (CI), if possible.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.752</p_value>
            <method>Log Rank</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival, Subgroup 2 Analysis</title>
        <description>Survival time of patients from start of treatment until death, Subgroup 2 categorizing 26 overall participants into 13 primary cutaneous angiosarcoma versus 13 secondary angiosarcomas</description>
        <time_frame>from start of treatment until death within study's actual observation time for OS (22 months)</time_frame>
        <population>Overall number of participants analyzed is 26. Thereof, 13 show cutaneous angiosarcoma, and 13 show cutaneos angiosarcoma</population>
        <group_list>
          <group group_id="O1">
            <title>Pazopanib + Paclitaxel</title>
            <description>Paclitaxel i.v. infusion over 6 cycles, administered on day 1, day 8, day 15 of every cycle with a dosage of 70mg/m2 in combination with Pazopanib taken orally with a dosage of 800mg daily/once per day in the treatment of patients with advanced or metastatic angiosarcoma.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival, Subgroup 2 Analysis</title>
          <description>Survival time of patients from start of treatment until death, Subgroup 2 categorizing 26 overall participants into 13 primary cutaneous angiosarcoma versus 13 secondary angiosarcomas</description>
          <population>Overall number of participants analyzed is 26. Thereof, 13 show cutaneous angiosarcoma, and 13 show cutaneos angiosarcoma</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="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>primary angiosarcoma</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.5" lower_limit="10.0" upper_limit="NA">The upper bound of the 95% CI could not be estimated, because of too low number of events resulting in the curve representing the upper limit of confidence interval lying above 0.5.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>secondary angiosarcoma</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.6" lower_limit="NA" upper_limit="NA">The upper and lower bound of the 95% CI could not be estimated, because of too low number of events resulting in curves representing the upper as well as the lower limit of confidence interval lying above 0.5.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>The analysis of secondary endpoints is of descriptive nature and generally consists of summary statistics and interval estimation.&#xD;
Overall survival (OS) for subgroup 2 was defined as the time of start of treatment until death (event status=1) or last contact (censoring, event status=0). OS was analyzed using Kaplan-Meier curves. Median survival time is provided alonsgside two-sided 95% confidence interval (CI), if possible.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.621</p_value>
            <method>Log Rank</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Response Rate (RR)</title>
        <description>Measurable skin lesions will be evaluated clinically and documented photographically, all other target lesions will be evaluated radiologically by CT or MRI according to RECIST Version 1.1.&#xD;
RR is given as 'Best overall response&quot; BOR&quot; defined as CR (complete remission), PR (partial) remission), SD (stable diesease) and PD (progressive disease) or NE (not evaluated) and provided by absolute and relative frequencies</description>
        <time_frame>determined every 8 weeks during first 6 month then every 12 weeks in follow-up period until progression or death or end of overall study observation period (22 months), then evaluated as BOR</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pazopanib + Paclitaxel</title>
            <description>Paclitaxel administered every 28 days at day 1, day 8 and day 15 as a 2h intravenous infusion in a dose of 70mg/m2 in combination with pazopanib in a daily oral dose of 800mg (2x400mg) in the treatment of patients with advanced or metastatic angiosarcoma.</description>
          </group>
        </group_list>
        <measure>
          <title>Response Rate (RR)</title>
          <description>Measurable skin lesions will be evaluated clinically and documented photographically, all other target lesions will be evaluated radiologically by CT or MRI according to RECIST Version 1.1.&#xD;
RR is given as 'Best overall response&quot; BOR&quot; defined as CR (complete remission), PR (partial) remission), SD (stable diesease) and PD (progressive disease) or NE (not evaluated) and provided by absolute and relative frequencies</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>CR</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>PR</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>SD</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>PD</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>NE</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <other_analysis_desc>Frequency of each category is given</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Response Rate (RR), Subgroup1 Analysis</title>
        <description>Measurable skin lesions will be evaluated clinically and documented photographically, all other target lesions will be evaluated radiologically by CT or MRI according to RECIST Version 1.1.&#xD;
RR is given as 'Best overall response&quot; BOR&quot; defined as CR (complete remission), PR (partial) remission), SD (stable diesease) and PD (progressive disease) or NE (not evaluated) and provided by absolute and relative frequencies for Subgroup 1 which is the analysis of cutaneous angiosarcoma versus visceral angiosarcoma</description>
        <time_frame>determined every 8 weeks during first 6 month then every 12 weeks in follow-up period until progression or death or end of overall study observation period (22 months), then evaluated as BOR</time_frame>
        <population>Total number of participants analyzed is 26. Thereof, 18 show cutaneous AS, and 8 show visceral angiosarcoma</population>
        <group_list>
          <group group_id="O1">
            <title>Pazopanib + Paclitaxel</title>
            <description>Paclitaxel i.v. infusion over 6 cycles, administered on day 1, day 8, day 15 of every cycle with a dosage of 70mg/m2 in combination with Pazopanib taken orally with a dosage of 800mg daily/once per day in the treatment of patients with advanced or metastatic angiosarcoma.</description>
          </group>
        </group_list>
        <measure>
          <title>Response Rate (RR), Subgroup1 Analysis</title>
          <description>Measurable skin lesions will be evaluated clinically and documented photographically, all other target lesions will be evaluated radiologically by CT or MRI according to RECIST Version 1.1.&#xD;
RR is given as 'Best overall response&quot; BOR&quot; defined as CR (complete remission), PR (partial) remission), SD (stable diesease) and PD (progressive disease) or NE (not evaluated) and provided by absolute and relative frequencies for Subgroup 1 which is the analysis of cutaneous angiosarcoma versus visceral angiosarcoma</description>
          <population>Total number of participants analyzed is 26. Thereof, 18 show cutaneous AS, and 8 show visceral angiosarcoma</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="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>cutaneous angiosarcoma</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>CR</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>PR</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>SD</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>PD</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>NE</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>visceral angiosarcoma</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>CR</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>PR</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>SD</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>PD</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>NE</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Response Rate (RR) is given as Best Overall Response (BOR) and given be absolute and relative frequencies. Categories of BOR are CR, PR, SD, PD and NE)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.349</p_value>
            <method>Chi squared test, exact</method>
            <other_analysis_desc>Response Rate (RR) is given as Best Overall Response (BOR) and given be absolute and relative frequencies applied to the total of 26 enrolled subjects.. Categories of BOR are CR, PR, SD, PD and NE).</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Response Rate (RR), Subgroup 2 Analysis</title>
        <description>Measurable skin lesions will be evaluated clinically and documented photographically, all other target lesions will be evaluated radiologically by CT or MRI according to RECIST Version 1.1.&#xD;
RR is given as 'Best overall response&quot; BOR&quot; defined as CR (complete remission), PR (partial) remission), SD (stable diesease) and PD (progressive disease) or NE (not evaluated) and provided by absolute and relative frequencies for Subgroup 2 which is the analysis of primary angiosarcoma versus secondary angiosarcoma</description>
        <time_frame>determined every 8 weeks during first 6 month then every 12 weeks in follow-up period until progression or death or end of overall study observation period (22 months), then evaluated as BOR</time_frame>
        <population>Total number of participants analyzed is 26. Thereof, 13 show primary angiosarcoma, and 13 show secondary angiosarcoma</population>
        <group_list>
          <group group_id="O1">
            <title>Pazopanib + Paclitaxel</title>
            <description>Paclitaxel i.v. infusion over 6 cycles, administered on day 1, day 8, day 15 of every cycle with a dosage of 70mg/m2 in combination with Pazopanib taken orally with a dosage of 800mg daily/once per day in the treatment of patients with advanced or metastatic angiosarcoma.</description>
          </group>
        </group_list>
        <measure>
          <title>Response Rate (RR), Subgroup 2 Analysis</title>
          <description>Measurable skin lesions will be evaluated clinically and documented photographically, all other target lesions will be evaluated radiologically by CT or MRI according to RECIST Version 1.1.&#xD;
RR is given as 'Best overall response&quot; BOR&quot; defined as CR (complete remission), PR (partial) remission), SD (stable diesease) and PD (progressive disease) or NE (not evaluated) and provided by absolute and relative frequencies for Subgroup 2 which is the analysis of primary angiosarcoma versus secondary angiosarcoma</description>
          <population>Total number of participants analyzed is 26. Thereof, 13 show primary angiosarcoma, and 13 show secondary angiosarcoma</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="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>primary angiosarcoma</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>CR</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>PR</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>SD</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>PD</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>NE</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>secondary angiosarcoma</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>CR</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>PR</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>SD</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>PD</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>NE</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.385</p_value>
            <method>Chi squared test, exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adverse Events and Serious Adverse Events</title>
        <description>Number of patients in which adverse events occur during treatment according to Common Toxicity Criteria for Adverse Effects, Version 4.0</description>
        <time_frame>30 days after EOS of last patient or end of overall study observation period (22 months)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pazopanib + Paclitaxel</title>
            <description>Paclitaxel administered every 28 days at day 1, day 8 and day 15 as a 2h intravenous infusion in a dose of 70mg/m2 in combination with pazopanib in a daily oral dose of 800mg (2x400mg) in the treatment of patients with advanced or metastatic angiosarcoma.</description>
          </group>
        </group_list>
        <measure>
          <title>Adverse Events and Serious Adverse Events</title>
          <description>Number of patients in which adverse events occur during treatment according to Common Toxicity Criteria for Adverse Effects, Version 4.0</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Patients with AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patients with SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse Events were collected over the study observation period which was 22 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Pazopanib + Paclitaxel</title>
          <description>Paclitaxel i.v. infusion over 6 cycles, administered on day 1, day 8, day 15 of every cycle with a dosage of 70mg/m2 in combination with Pazopanib taken orally with a dosage of 800 mg daily/once per day in the treatment of patients with advanced or metastatic angiosarcoma.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (Unspecified)</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="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Palpitation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastrointestinal bleeding</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fever of unknown origin</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Reduced general condition</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>ALT increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Bilirubin increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>GOT increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>GPT increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Erysipelas</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pain in thoracic spine</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Lumbar spinal stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (Unspecified)</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="25" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="3" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" events="28" subjects_affected="6" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="18" subjects_affected="5" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="29" subjects_affected="16" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Emesis</sub_title>
                <counts group_id="E1" events="8" subjects_affected="3" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Meteorism</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Obstipation</sub_title>
                <counts group_id="E1" events="7" subjects_affected="4" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" events="12" subjects_affected="6" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="14" subjects_affected="8" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Reduced general condition</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Pain foot</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="26" subjects_affected="12" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Mucositis</sub_title>
                <counts group_id="E1" events="6" subjects_affected="4" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Thoracical pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Oedema leg</sub_title>
                <counts group_id="E1" events="11" subjects_affected="7" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>ALT increased</sub_title>
                <counts group_id="E1" events="12" subjects_affected="4" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>AST increased</sub_title>
                <counts group_id="E1" events="12" subjects_affected="4" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Bilirubin increased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Acute nasopharyngitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Erysipels</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Weight loss</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Exsikkosis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Inappetance</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Dorsalgia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" events="21" subjects_affected="11" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Neuropathia</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Allergic reation to a drug</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="6" subjects_affected="4" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Hand-foot syndrome</sub_title>
                <counts group_id="E1" events="11" subjects_affected="5" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Nail dystrophia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="17" subjects_affected="12" subjects_at_risk="26"/>
              </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>Prof. Dr. med. Peter Hohenberger</name_or_title>
      <organization>Universität Heidelberg/Universitätsmedizin Mannheim</organization>
      <phone>+49 0621 383 2609</phone>
      <email>peter.hohenberger@umm.de</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/NCT02212015
org study id: GISG-06
nct id: NCT02212015
lead sponsor: 
collaborator: 
collaborator: 
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has dmc: No
Open-label phase II trial investigating the efficacy and safety of the investigational
      combination of pazopanib and paclitaxel.
Open-label phase II trial investigating the efficacy and safety of the investigational
      combination of pazopanib and paclitaxel.This multi-center, open-label, prospective, single
      arm phase II study was designed to evaluate the clinical efficacy and safety of the
      experimental combination of pazopanib with paclitaxel in the treatment of patients with
      advanced or metastatic angiosarcoma.The safety evaluations (physical examination, laboratory
      checks as defined in protocol, toxicity/adverse event assessment according Eastern
      Cooperative Oncology Group version 4.0) are scheduled every cycle at day 1, 8, 15 and 29 (=
      day 1 of the next cycle).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Rate of Progression-free Survival
time frame: 6 Month
description: The diagnosis of progession is based on tumor measurements assessed 182 days +/- 32 days after start of treatment (with imaging date as reference date) and according to the RECIST Version 1.1 criteria based on a predefined set of target lesions and non-target lesions.
measure: Rate of Progression-free Survival, Subgroup 1 Analysis
time frame: 6 months
description: Rate of progression-free survival for Subgroup 1 categorizing the 12 participants who showed PFS after 6 months into cutaneous angiosarcoma versus visceral angiosarcoma The diagnosis of progession is based on tumor measurements assessed 182 days +/- 32 days after start of treatment (with imaging date as reference date) and according to the RECIST Version 1.1 criteria based on a predefined set of target lesions and non-target lesions.
measure: Rate of Progression-free Survival, Subgroup 2 Analysis
time frame: 6 months
description: Rate of progression-free survival for Subgroup 1 categorizing the 12 participants who showed PFS after 6 months into primary angiosarcoma versus secondary angiosarcoma.
The diagnosis of progession is based on tumor measurements assessed 182 days +/- 32 days after start of treatment (with imaging date as reference date) and according to the RECIST Version 1.1 criteria based on a predefined set of target lesions and non-target lesions.
measure: Overall Survival
time frame: from start of treatment until death within study's actual observation time for OS (22 months).
description: Survival time of patient from start of treatment until death
measure: Overall Survival, Subgroup 1 Analysis
time frame: from start of treatment until death within study's actual observation time for OS (22 months)
description: Survival time of patients from start of treatment until death, Subgroup 1 categorizing 26 overall participants into 18 cutaneous angiosarcoma versus 8 visceral angiosarcomas
measure: Overall Survival, Subgroup 2 Analysis
time frame: from start of treatment until death within study's actual observation time for OS (22 months)
description: Survival time of patients from start of treatment until death, Subgroup 2 categorizing 26 overall participants into 13 primary cutaneous angiosarcoma versus 13 secondary angiosarcomas
measure: Response Rate (RR)
time frame: determined every 8 weeks during first 6 month then every 12 weeks in follow-up period until progression or death or end of overall study observation period (22 months), then evaluated as BOR
description: Measurable skin lesions will be evaluated clinically and documented photographically, all other target lesions will be evaluated radiologically by CT or MRI according to RECIST Version 1.1.
RR is given as 'Best overall response" BOR" defined as CR (complete remission), PR (partial) remission), SD (stable diesease) and PD (progressive disease) or NE (not evaluated) and provided by absolute and relative frequencies
measure: Response Rate (RR), Subgroup1 Analysis
time frame: determined every 8 weeks during first 6 month then every 12 weeks in follow-up period until progression or death or end of overall study observation period (22 months), then evaluated as BOR
description: Measurable skin lesions will be evaluated clinically and documented photographically, all other target lesions will be evaluated radiologically by CT or MRI according to RECIST Version 1.1.
RR is given as 'Best overall response" BOR" defined as CR (complete remission), PR (partial) remission), SD (stable diesease) and PD (progressive disease) or NE (not evaluated) and provided by absolute and relative frequencies for Subgroup 1 which is the analysis of cutaneous angiosarcoma versus visceral angiosarcoma
measure: Response Rate (RR), Subgroup 2 Analysis
time frame: determined every 8 weeks during first 6 month then every 12 weeks in follow-up period until progression or death or end of overall study observation period (22 months), then evaluated as BOR
description: Measurable skin lesions will be evaluated clinically and documented photographically, all other target lesions will be evaluated radiologically by CT or MRI according to RECIST Version 1.1.
RR is given as 'Best overall response" BOR" defined as CR (complete remission), PR (partial) remission), SD (stable diesease) and PD (progressive disease) or NE (not evaluated) and provided by absolute and relative frequencies for Subgroup 2 which is the analysis of primary angiosarcoma versus secondary angiosarcoma
measure: Adverse Events and Serious Adverse Events
time frame: 30 days after EOS of last patient or end of overall study observation period (22 months)
description: Number of patients in which adverse events occur during treatment according to Common Toxicity Criteria for Adverse Effects, Version 4.0
arm group label: Pazopanib + Paclitaxel
arm group type: Experimental
description: Paclitaxel administered every 28 days at day 1, day 8 and day 15 as a 2h intravenous infusion in a dose of 70mg/m2 in combination with pazopanib in a daily oral dose of 800mg (2x400mg)
intervention type: Drug
intervention name: Pazopanib + Paclitaxel
description: pazopanib in combination with paclitaxel in the treatment of patients with advanced or metastatic angiosarcoma.
arm group label: Pazopanib + Paclitaxel
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Peter Hohenberger, MD
role: Principal Investigator
affiliation: Universitätsmedizin Mannheim / Heidelberg University
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country: Austria
country: Germany
url: http://www.gisg.de
description: German Interdisciplinary Sarcoma Group
url: http://www.sarcoma.at
description: Sarcoma Platform Austria
responsible party type: Principal Investigator
investigator affiliation: Universitätsmedizin Mannheim
investigator full name: Peter Hohenberger
investigator title: Prof. Dr. med.
mesh term: Hemangiosarcoma
mesh term: Paclitaxel
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