<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/NCT02203760</url>
  </required_header>
  <id_info>
    <org_study_id>NOGGO U1</org_study_id>
    <secondary_id>2012-003810-15</secondary_id>
    <nct_id>NCT02203760</nct_id>
  </id_info>
  <brief_title>Pazopanib vs. Pazopanib Plus Gemcitabine</brief_title>
  <acronym>PazoDoble</acronym>
  <official_title>Pazopanib vs. Pazopanib Plus Gemcitabine in Patients With Relapsed or Metastatic Uterine Leiomyosarcomas or Uterine Carcinosarcomas: a Multi-center, Randomized Phase-II Clinical Trial of the NOGGO and AGO - PazoDoble -</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>North Eastern German Society of Gynaecological Oncology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Novartis Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>medac GmbH</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>North Eastern German Society of Gynaecological Oncology</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a prospective, randomized, open-label, multicenter phase II trial in order to&#xD;
      determine progression-free survival of patients with refractory or relapsed metastatic&#xD;
      uterine leiomyosarcomas or other metastatic uterine tumours.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study design:&#xD;
&#xD;
      This study is a prospective, randomized, open-label, multicenter phase II trial in order to&#xD;
      determine progression-free survival of patients with refractory or relapsed metastatic&#xD;
      uterine leiomyosarcomas or other metastatic uterine tumours.&#xD;
&#xD;
      Indication:&#xD;
&#xD;
      Relapsed or metastatic uterine leiomyosarcomas or carcinosarcomas&#xD;
&#xD;
      Randomization:&#xD;
&#xD;
      Patients with uterine leiomyosarcomas will be randomized in a 1:1-fashion to receive the&#xD;
      following therapy&#xD;
&#xD;
        -  Arm A: Pazopanib 800 mg orally once daily plus Gemcitabine 1000 mg/m2 i.v. over 30 min d&#xD;
           1 and d 8 q3w or&#xD;
&#xD;
        -  Arm B: Pazopanib 800 mg orally once daily Patients with uterine carcinosarcomas will be&#xD;
           treated according to Arm A.&#xD;
&#xD;
      Planned number of patients:&#xD;
&#xD;
      87 patients with uterine leiomyosarcomas 20 patients with uterine carcinosarcomas&#xD;
&#xD;
      Treatment schedules:&#xD;
&#xD;
      Patients with uterine leiomyosarcomas will be randomized in a 1:1-fashion to receive the&#xD;
      following therapy • Arm A (experimental arm / combination arm): Pazopanib 800 mg orally once&#xD;
      daily plus Gemcitabine 1000 mg/m2 i.v. over 30 min d 1 and d 8 q3w or&#xD;
&#xD;
      • Arm B (control arm / monotherapy arm): Pazopanib 800 mg orally once daily Patients with&#xD;
      uterine carcinosarcomas will be treated according to Arm A.&#xD;
&#xD;
      Planned treatment duration per subject:&#xD;
&#xD;
      Patients continue on study treatment until disease progression, death, unacceptable toxicity&#xD;
      or withdrawal of consent for any reason.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 16, 2019</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2022</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression free survival assessed as rate of patients without progression Second malignancy or clinical progression - patients with unknown or missing PFS will be treated as non-responder</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective response rate (RECIST v1.1 criteria)</measure>
    <time_frame>One year</time_frame>
    <description>Time to progression (TTP) of a patient being defined as the time in months from start of the first therapy cycle until PD is observed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective response rate (RECIST v1.1 criteria)</measure>
    <time_frame>One year</time_frame>
    <description>Overall survival (OS) calculated from the day of study enrolment until the day of death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective response rate (RECIST v1.1 criteria)</measure>
    <time_frame>one year</time_frame>
    <description>Progression-free survival (PFS) calculated from the day of study enrolment until the day of progression/death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety - side effects</measure>
    <time_frame>One year</time_frame>
    <description>Toxicity and tolerability</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life (EORTC QLQ-C30)</measure>
    <time_frame>One year</time_frame>
    <description>Quality of life (EORTC QLQ-C30)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Translational research program</measure>
    <time_frame>One year</time_frame>
    <description>Translational research within a tumour bank</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">107</enrollment>
  <condition>Leiomyosarcoma or Carcinosarcoma</condition>
  <arm_group>
    <arm_group_label>Pazopanib plus Gemcitabine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Arm A: Pazopanib 800 mg orally once daily plus Gemcitabine 1000 mg/m2 i.v. over 30 min d 1 and d 8 q3w or</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pazopanib</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Pazopanib 800 mg orally once daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pazopanib plus Gemcitabine</intervention_name>
    <description>Pazopanib 800 mg orally once daily plus Gemcitabine 1000 mg/m2 i.v. over 30 min d 1 and d 8 q3w or</description>
    <arm_group_label>Pazopanib plus Gemcitabine</arm_group_label>
    <other_name>Votrient and Gemzar</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pazopanib</intervention_name>
    <description>Pazopanib 800 mg orally once daily</description>
    <arm_group_label>Pazopanib</arm_group_label>
    <other_name>Votrient</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects must provide informed consent prior to performance of study-specific&#xD;
             procedures or assessments, and must be willing to comply with treatment and follow-up.&#xD;
             Procedures conducted as part of the subject's routine clinical management (e.g., blood&#xD;
             count, imaging study) and obtained prior to signing of informed consent may be&#xD;
             utilized for screening or baseline purposes provided these procedures are conducted as&#xD;
             specified in the protocol&#xD;
&#xD;
          2. Histologically or cytological confirmed uterine leiomyosarcoma or uterine&#xD;
             carcinosarcoma including any subtypes&#xD;
&#xD;
          3. Patients with a contraindication for doxorubicin OR patients must have received prior&#xD;
             chemotherapies&#xD;
&#xD;
          4. For patients with prior anthracycline therapy normal cardiac function with LVEF at&#xD;
             least 50% must be assessed by quantitative echocardiogram or MUGA scan&#xD;
&#xD;
          5. Prior Gemcitabine containing chemotherapy is permitted provided that at least 8 weeks&#xD;
             have elapsed since the last dose of therapy&#xD;
&#xD;
          6. ECOG performance status 0-1&#xD;
&#xD;
          7. At least 18 years old&#xD;
&#xD;
          8. Measurable disease according to RECIST v 1.1 criteria (in case of tumour debulking -&#xD;
             staging CT-scan after surgery)&#xD;
&#xD;
          9. Able to swallow and retain oral medication&#xD;
&#xD;
         10. Adequate organ system function as defined in Table 1&#xD;
&#xD;
        Table 1: Definitions for Adequate Organ Function System Laboratory Values Hematologic&#xD;
        Absolute neutrophil count (ANC) &gt; = 1.5 X 109/L Hemoglobin1 &gt; = 9 g/dL (5.6 mmol/L)&#xD;
        Platelets &gt; = 100 X 109/L Prothrombin time (PT) or international normalized ratio (INR)4 &lt;=&#xD;
        1.2 X upper limit of normal (ULN) Partial thromboplastin time (PTT) &lt;=1.2 X ULN Hepatic2&#xD;
        Total bilirubin &lt;= 1.5 X ULN AST and ALT &lt;= 2.5 X ULN Renal Serum creatinine &lt;= 1.5 mg/dL&#xD;
        (133 µmol/L)&#xD;
&#xD;
        Or, if greater than 1.5 mg/dL:&#xD;
&#xD;
        Calculated creatinine clearance &gt; = 50 mL/min&#xD;
&#xD;
        Urine Protein to Creatinine Ratio (UPC)3 &lt; 1&#xD;
&#xD;
          1. Subjects may not have had a transfusion within 7 days prior to screening assessment.&#xD;
&#xD;
          2. Concomitant elevations in bilirubin and AST/ALT above 1.0 x ULN are not permitted&#xD;
&#xD;
          3. If UPC &gt; = 1, then a 24-hour urine protein must be assessed. Subjects must have a&#xD;
             24-hour urine protein value &lt;1g to be eligible.&#xD;
&#xD;
          4. Subjects receiving anticoagulant therapy are eligible if their INR is stable and&#xD;
             within the recommended range for the desired level of anticoagulation&#xD;
&#xD;
        11. Non-childbearing potential (i.e., physiologically incapable of becoming pregnant),&#xD;
        including any female who has had:&#xD;
&#xD;
          -  A hysterectomy&#xD;
&#xD;
          -  A bilateral oophorectomy (ovariectomy)&#xD;
&#xD;
          -  A bilateral tubal ligation&#xD;
&#xD;
          -  Is post-menopausal Subjects not using hormone replacement therapy (HRT) must have&#xD;
             experienced total cessation of menses for ≥ 1 year and be greater than 45 years in&#xD;
             age, OR, in questionable cases, have a follicle stimulating hormone (FSH) value &gt;40&#xD;
             mIU/mL and an estradiol value &lt; 40pg/mL (&lt;140 pmol/L).&#xD;
&#xD;
        Subjects using HRT must have experienced total cessation of menses for &gt;= 1 year and be&#xD;
        greater than 45 years of age OR have had documented evidence of menopause based on FSH and&#xD;
        estradiol concentrations prior to initiation of HRT&#xD;
&#xD;
        OR&#xD;
&#xD;
        Negative serum pregnancy test of women of childbearing potential performed within 1 week&#xD;
        prior to the first dose of study treatment, preferably as close to the first dose as&#xD;
        possible, and agrees to use adequate contraception. Acceptable contraceptive methods, when&#xD;
        used consistently and in accordance with the product label and the instructions of the&#xD;
        physicians are as followed for 14 days before exposure to investigational product, through&#xD;
        the dosing period and for at least 21 days after the last dose of investigational product:&#xD;
&#xD;
          -  Complete abstinence from sexual intercourse&#xD;
&#xD;
          -  Oral contraceptive, either combined or progestogen alone&#xD;
&#xD;
          -  Injectable progestogen&#xD;
&#xD;
          -  Implants of levonorgestrel&#xD;
&#xD;
          -  Estrogenic vaginal ring&#xD;
&#xD;
          -  Percutaneous contraceptive patches&#xD;
&#xD;
          -  Intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate&#xD;
             of less than 1% per year&#xD;
&#xD;
          -  Male partner sterilization (vasectomy with documentation of azoospermia) prior to the&#xD;
             female subject's entry into the study, and this male is the sole partner for that&#xD;
             subject&#xD;
&#xD;
          -  Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps)&#xD;
             with a vaginal spermicidal agent (foam/gel/film/cream/suppository) Female subjects who&#xD;
             are lactating should discontinue nursing prior to the first dose of study drug and&#xD;
             should refrain from nursing throughout the treatment period and for 14 days following&#xD;
             the last dose of study drug.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Prior malignancy&#xD;
&#xD;
             • Note: Subjects who have had another malignancy and have been disease-free for 5&#xD;
             years, or subjects with a history of completely resected non-melanomatous skin&#xD;
             carcinoma or successfully treated in situ carcinoma are eligible.&#xD;
&#xD;
          2. Patient has received prior treatment with any anti-angiogenic agent including&#xD;
             bevacizumab and tyrosine kinase inhibitors&#xD;
&#xD;
          3. Active malignancy or any malignancy in the last 5 years prior to first dose of study&#xD;
             drug other than LMS and CS&#xD;
&#xD;
          4. History or clinical evidence of central nervous system (CNS) or leptomeningeal&#xD;
             metastases, except for individuals who have previously-treated CNS metastases, are&#xD;
             asymptomatic, and have had no requirement for steroids or anti-seizure medication for&#xD;
             6 months prior to first dose of study drug. Screening with CNS imaging studies&#xD;
             (computed tomography [CT] or magnetic resonance imaging [MRI]) is required only if&#xD;
             clinically indicated or if the subject has a history of CNS metastases&#xD;
&#xD;
          5. Clinically significant gastrointestinal abnormalities that may increase the risk for&#xD;
             gastrointestinal bleeding including, but not limited to:&#xD;
&#xD;
               -  Active peptic ulcer disease&#xD;
&#xD;
               -  Known intraluminal metastatic lesion/s with risk of bleeding&#xD;
&#xD;
               -  Inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease), or other&#xD;
                  gastrointestinal conditions with increased risk of perforation&#xD;
&#xD;
               -  History of abdominal fistula, gastrointestinal perforation, or intra-abdominal&#xD;
                  abscess within 28 days prior to beginning study treatment&#xD;
&#xD;
               -  Grade 3/4 diarrhea&#xD;
&#xD;
          6. Corrected QT interval (QTc) &gt; 450 Milliseconds using Barzett's formula&#xD;
&#xD;
          7. History of any one or more of the following cardiovascular conditions within the past&#xD;
             6 months:&#xD;
&#xD;
               -  Cardiac angioplasty or stenting&#xD;
&#xD;
               -  Myocardial infarction&#xD;
&#xD;
               -  Unstable angina&#xD;
&#xD;
               -  Coronary artery bypass graft surgery&#xD;
&#xD;
               -  Symptomatic peripheral vascular disease&#xD;
&#xD;
               -  Class III or IV congestive heart failure, as defined by the New York Heart&#xD;
                  Association (NYHA)&#xD;
&#xD;
               -  Poorly controlled hypertension [defined as systolic blood pressure (SBP) of ≥140&#xD;
                  mmHg or diastolic blood pressure (DBP) of ≥ 90 mmHg].&#xD;
&#xD;
             Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to&#xD;
             study entry. BP must be re-assessed on two occasions that are separated by a minimum&#xD;
             of 1 hour; on each of these occasions, the mean (of 3 readings) SBP / DBP values from&#xD;
             each BP assessment must be &lt;140/90 mmHg in order for a subject to be eligible for the&#xD;
             study (refer to study protocol for details on BP control and re-assessment prior to&#xD;
             study enrollment)&#xD;
&#xD;
          8. History of cerebrovascular accident including transient ischemic attack (TIA),&#xD;
             pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.&#xD;
&#xD;
             • Note: Subjects with recent DVT who have been treated with therapeutic&#xD;
             anti-coagulating agents for at least 6 weeks are eligible&#xD;
&#xD;
          9. Major surgery or trauma within 28 days prior to study enrolment or any non- healing&#xD;
             wound, fracture or ulcer (procedures such as catheter placement not considered to be&#xD;
             major)&#xD;
&#xD;
         10. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs&#xD;
             chemically related to Pazopanib or Gemcitabine&#xD;
&#xD;
         11. Evidence of active bleeding or bleeding diathesis&#xD;
&#xD;
         12. Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels&#xD;
&#xD;
         13. Hemoptysis in excess of 2.5 mL(or one half teaspoon) within 8 weeks prior to the first&#xD;
             dose of study drug&#xD;
&#xD;
         14. Any serious and/or unstable pre-existing medical, psychiatric, or other condition that&#xD;
             could interfere with subject's safety, provision of informed consent, or compliance to&#xD;
             study procedures&#xD;
&#xD;
         15. Unable or unwilling to discontinue use of prohibited medications listed in the study&#xD;
             protocol for at least 14 days or five half-lives of a drug (whichever is longer) prior&#xD;
             to the first dose of study drug and for the duration of the study&#xD;
&#xD;
         16. Treatment with any of the following anti-cancer therapies&#xD;
&#xD;
               -  Radiation therapy, surgery or tumour embolization within 14 days prior to the&#xD;
                  first dose of study drug&#xD;
&#xD;
               -  Chemotherapy, immunotherapy, biologic therapy, investigational therapy or&#xD;
                  hormonal therapy within 14 days or five half-lives of a drug (whichever is&#xD;
                  longer) prior to the first dose of study drug&#xD;
&#xD;
         17. Any ongoing toxicity from prior anti-cancer therapy that is &gt;Grade 1 and/or that is&#xD;
             progressing in severity, except alopecia&#xD;
&#xD;
         18. Pregnancy (for women of childbearing potential to be confirmed by negative serum&#xD;
             pregnancy test) or lactation period&#xD;
&#xD;
             Women of childbearing potential:&#xD;
&#xD;
             missing contraception (Pearl-Index &lt;1, e.g. hormonal contraception including the&#xD;
             combined oral contraceptive pill, the transdermal patch, and the contraceptive vaginal&#xD;
             ring, intrauterine devices or sterilization) for 14 days before exposure to&#xD;
             investigational product, during study treatment and for at least 21 days after the&#xD;
             last dose of investigational product.&#xD;
&#xD;
         19. Medical or psychological conditions that would not permit the subject to complete the&#xD;
             study or sign informed consent&#xD;
&#xD;
         20. Legal incapacity or limited legal capacity&#xD;
&#xD;
         21. Participation in another clinical study with experimental therapy within 30 days prior&#xD;
             to study enrolment&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alexander Mustea, Prof. Dr. med.</last_name>
    <role>Study Chair</role>
    <affiliation>University Hospital, Bonn</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Alexander Mustea, Prof. Dr. med.</last_name>
    <phone>+49 (0) 0228 287 154 44</phone>
    <email>mustea@ukbonn.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Eva Egger, Dr. med.</last_name>
    <email>eva-katherina.egger@ukbonn.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Helios Klinikum Bad Saarow, Hämatologie, Onkologie und Palliativmedizin, Sarkomzentrum</name>
      <address>
        <city>Bad Saarow</city>
        <zip>15526</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Daniel Pink, Dr. med.</last_name>
      <phone>033631 73527</phone>
      <email>daniel.pink@helios-gesundheit.de</email>
    </contact>
    <contact_backup>
      <last_name>Daniel Schöndube, Dr. med.</last_name>
      <email>daniel.schoendube@helios-gesundheit.de</email>
    </contact_backup>
    <investigator>
      <last_name>Daniel Pink, Dr. med.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Daniel Schöndube</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Helios Klinikum Berlin-Buch, Klinik für Onkologie und Paliativmedizin</name>
      <address>
        <city>Berlin</city>
        <zip>13125</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Peter Reichardt, PD Dr. med.</last_name>
      <phone>030 94 01 54800</phone>
      <email>peter.reichardt@helios-gesundheit.de</email>
    </contact>
    <contact_backup>
      <last_name>Saeed Ghani, Dr. med</last_name>
      <email>saeed.ghani@helios-gesundheit.de</email>
    </contact_backup>
    <investigator>
      <last_name>Peter Reichardt, PD Dr. med.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Saed Ghani, Dr. med.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Universitätsmedizin Berlin Charité Campus Virchow-Klinikum</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jalid Sehouli, Professor Dr. med.</last_name>
      <phone>+4930/ 450 564 002</phone>
      <email>jalid.sehouli@charite.de</email>
    </contact>
    <contact_backup>
      <last_name>Radoslav Chekorov, Dr. med.</last_name>
      <phone>+4930/450-664399</phone>
      <email>radoslav.chekerov@charite.de</email>
    </contact_backup>
    <investigator>
      <last_name>Jalid Sehouli, Prof. Dr. med.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Radoslav Chekorov, Dr. med.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Bonn</name>
      <address>
        <city>Bonn</city>
        <zip>53127</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alexander Mustea, Prof. Dr.</last_name>
      <phone>+49228287154 44</phone>
      <email>mustea@ukbonn.de</email>
    </contact>
    <contact_backup>
      <last_name>Eva Egger, Dr.</last_name>
      <email>eva-katherina.egger@ukbonn.de</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Universitätsklinik Carl Gustav Carus der Technischen Universität Dresden Klinik für Frauenheilkunde und Geburtshilfe</name>
      <address>
        <city>Dresden</city>
        <zip>01807</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Pauline Wimberger, Prof. Dr. med.</last_name>
      <phone>+49351/4 58 6728</phone>
      <email>pauline.wimberger@uniklinikum-dresden.de</email>
    </contact>
    <contact_backup>
      <last_name>Theresa Link, Dr. med.</last_name>
      <phone>+49351/458-18084</phone>
      <email>theresa.link@uniklinikum-dresden.de</email>
    </contact_backup>
    <investigator>
      <last_name>Pauline Wimberger, Prof. Dr. med.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Theresa Link, Dr. med.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kliniken-Essen-Mitte Evang. Huyssens-Stiftung Klinik für Senologie / Brustzentrum</name>
      <address>
        <city>Essen</city>
        <zip>45136</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Phillip Harter, Dr. med.</last_name>
      <email>p.harter@kliniken-essen-mitte.de</email>
    </contact>
    <contact_backup>
      <last_name>Florian Heitz, Dr. med.</last_name>
      <email>f.heitz@kliniken-essen-mitte.de</email>
    </contact_backup>
    <investigator>
      <last_name>Phillip Harter, Dr. med.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Florian Heitz, Dr. med.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Universitätsmedizin Greifswald Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe</name>
      <address>
        <city>Greifswald</city>
        <zip>17475</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zaher Alwafai, Dr.</last_name>
      <email>zaher.alwafai@med.uni-greifswald.de</email>
    </contact>
    <contact_backup>
      <last_name>Claudia Kolbe, Dr.</last_name>
      <email>claudia.kolbe@med.uni-greifswald.de</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Jena</name>
      <address>
        <city>Jena</city>
        <zip>07747</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ingo Runnebaum, Prof. Dr.</last_name>
      <email>Ingo.Runnebaum@med.uni-jena.de</email>
    </contact>
    <contact_backup>
      <last_name>Matthias Rengsberger, Dr.</last_name>
      <email>matthias.rengsberger@med.uni-jena.de</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Universitätsfrauenklinik Tübingen</name>
      <address>
        <city>Tübingen</city>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eva-Maria Grischke, Prof. Dr. med.</last_name>
      <phone>+497071/ 298 2212</phone>
      <email>eva-maria.grischke@med.uni-tuebingen.de</email>
    </contact>
    <contact_backup>
      <last_name>Andreas Hartkopf, Prof. Dr. med.</last_name>
    </contact_backup>
    <investigator>
      <last_name>Eva-Maria Grischke, Prof. Dr. med.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Christian Wieland Gall, Dr. med.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>May 5, 2014</study_first_submitted>
  <study_first_submitted_qc>July 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <last_update_submitted>November 27, 2020</last_update_submitted>
  <last_update_submitted_qc>November 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Relapsed/metastatic uterine leiomyosarcomas/carcinosarcomas</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leiomyosarcoma</mesh_term>
    <mesh_term>Carcinosarcoma</mesh_term>
    <mesh_term>Mixed Tumor, Mullerian</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gemcitabine</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02203760
org study id: NOGGO U1
secondary id: 2012-003810-15
nct id: NCT02203760
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is a prospective, randomized, open-label, multicenter phase II trial in order to
      determine progression-free survival of patients with refractory or relapsed metastatic
      uterine leiomyosarcomas or other metastatic uterine tumours.
Study design:

      This study is a prospective, randomized, open-label, multicenter phase II trial in order to
      determine progression-free survival of patients with refractory or relapsed metastatic
      uterine leiomyosarcomas or other metastatic uterine tumours.

      Indication:

      Relapsed or metastatic uterine leiomyosarcomas or carcinosarcomas

      Randomization:

      Patients with uterine leiomyosarcomas will be randomized in a 1:1-fashion to receive the
      following therapy

        -  Arm A: Pazopanib 800 mg orally once daily plus Gemcitabine 1000 mg/m2 i.v. over 30 min d
           1 and d 8 q3w or

        -  Arm B: Pazopanib 800 mg orally once daily Patients with uterine carcinosarcomas will be
           treated according to Arm A.

      Planned number of patients:

      87 patients with uterine leiomyosarcomas 20 patients with uterine carcinosarcomas

      Treatment schedules:

      Patients with uterine leiomyosarcomas will be randomized in a 1:1-fashion to receive the
      following therapy • Arm A (experimental arm / combination arm): Pazopanib 800 mg orally once
      daily plus Gemcitabine 1000 mg/m2 i.v. over 30 min d 1 and d 8 q3w or

      • Arm B (control arm / monotherapy arm): Pazopanib 800 mg orally once daily Patients with
      uterine carcinosarcomas will be treated according to Arm A.

      Planned treatment duration per subject:

      Patients continue on study treatment until disease progression, death, unacceptable toxicity
      or withdrawal of consent for any reason.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression free survival assessed as rate of patients without progression Second malignancy or clinical progression - patients with unknown or missing PFS will be treated as non-responder
time frame: 6 months
measure: Objective response rate (RECIST v1.1 criteria)
time frame: One year
description: Time to progression (TTP) of a patient being defined as the time in months from start of the first therapy cycle until PD is observed
measure: Objective response rate (RECIST v1.1 criteria)
time frame: One year
description: Overall survival (OS) calculated from the day of study enrolment until the day of death
measure: Objective response rate (RECIST v1.1 criteria)
time frame: one year
description: Progression-free survival (PFS) calculated from the day of study enrolment until the day of progression/death
measure: Safety - side effects
time frame: One year
description: Toxicity and tolerability
measure: Quality of life (EORTC QLQ-C30)
time frame: One year
description: Quality of life (EORTC QLQ-C30)
measure: Translational research program
time frame: One year
description: Translational research within a tumour bank
arm group label: Pazopanib plus Gemcitabine
arm group type: Experimental
description: Arm A: Pazopanib 800 mg orally once daily plus Gemcitabine 1000 mg/m2 i.v. over 30 min d 1 and d 8 q3w or
arm group label: Pazopanib
arm group type: Active Comparator
description: Pazopanib 800 mg orally once daily
intervention type: Drug
intervention name: Pazopanib plus Gemcitabine
description: Pazopanib 800 mg orally once daily plus Gemcitabine 1000 mg/m2 i.v. over 30 min d 1 and d 8 q3w or
arm group label: Pazopanib plus Gemcitabine
other name: Votrient and Gemzar
intervention type: Drug
intervention name: Pazopanib
description: Pazopanib 800 mg orally once daily
arm group label: Pazopanib
other name: Votrient
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alexander Mustea, Prof. Dr. med.
role: Study Chair
affiliation: University Hospital, Bonn
last name: Alexander Mustea, Prof. Dr. med.
phone: +49 (0) 0228 287 154 44
email: mustea@ukbonn.de
last name: Eva Egger, Dr. med.
email: eva-katherina.egger@ukbonn.de
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Not yet recruiting
contact: 
contact backup: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: Germany
responsible party type: Sponsor
mesh term: Leiomyosarcoma
mesh term: Carcinosarcoma
mesh term: Mixed Tumor, Mullerian
mesh term: Gemcitabine