<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/NCT03810976</url>
  </required_header>
  <id_info>
    <org_study_id>4-2017-0933</org_study_id>
    <nct_id>NCT03810976</nct_id>
  </id_info>
  <brief_title>A Study of Eribulin With Gemcitabine in Patients With Advanced Liposarcoma or Leiomyosarcoma</brief_title>
  <official_title>Open-label, Phase II Trial of Eribulin in Combination With Gemcitabine in Previously Treated Patients With Advanced Liposarcoma or Leiomyosarcoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The eribulin, a microtubule-dynamics inhibitor was approved for specific subtypes of STS.&#xD;
      Eribulin demonstrated significantly better OS compared to dacarbazine in previously treated&#xD;
      patients with liposarcoma and leiomyosarcoma and approved as standard treatment. However, the&#xD;
      median progression free survival (PFS) and response rate (RR) was similar for both groups&#xD;
      which remains modest outcome of 2.6 months of PFS and 4% of RR. Therefore, to improve&#xD;
      antitumor activity, further combination strategy is strongly warranted. Based on the previous&#xD;
      studies, investigators suggest phase II trial of eribulin and gemcitabine combination in&#xD;
      previously treated patients with unresectable, advanced, or metastatic leiomyosarcoma or&#xD;
      liposarcoma.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 27, 2018</start_date>
  <completion_date type="Actual">May 30, 2022</completion_date>
  <primary_completion_date type="Actual">May 30, 2022</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>progression free survival</measure>
    <time_frame>12 weeks</time_frame>
    <description>To evaluate antitumor efficacy of eribulin and gemcitabine combination</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>adverse event</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
    <description>to evaluate safety</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>Sarcoma</condition>
  <arm_group>
    <arm_group_label>eribulin+gemcitabine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The dose is 1.4 mg/m2 for 5 minutes intravenously. If necessary, the dose may be diluted in up to 100 mL of saline solution prior to intravenous administration. Gemcitabine doses 1000 mg/m2 intravenously for 30 minutes. After completion of the eribulin injection, intravenously inject gemcitabine. One cycle is 3 weeks, and the treatment is carried out on the 1st day and the 8th day for each cycle.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Eribulin, gemcitabine</intervention_name>
    <description>Elibulin 1.4mg/m2 Intravenous for 5minutes. Day 1&amp; Day 8 every 3 weeks Gemcitabine 1000mg/m2 intraveoust for 30 minutes, Day 1&amp; Day 8 every 3 weeks</description>
    <arm_group_label>eribulin+gemcitabine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Histologically confirmed advanced liposarcoma or leiomyosarcoma with 1-2 prior&#xD;
             chemotherapy including anthracycline (unless contraindicated)&#xD;
&#xD;
          2. ECOG performance status of 0-2&#xD;
&#xD;
          3. Measurable or evaluable disease (RECIST 1.1.)&#xD;
&#xD;
          4. Adequate laboratory findings&#xD;
&#xD;
               -  Hb ≥ 9.0 g/dL&#xD;
&#xD;
               -  Absolute neutrophil count ≥ 1000 /µL&#xD;
&#xD;
               -  Platelet ≥ 75,000/ µL&#xD;
&#xD;
               -  Total Bilirubin: ≤ 1.5 × UNL (upper normal limit) (≤ 2 × UNL in patients with&#xD;
                  liver metastasis)&#xD;
&#xD;
               -  Serum Creatinine: ≤1.5 X upper limit of normal (ULN) OR ≥ Creatinine Clearance 60&#xD;
                  mL/min (Cockcroft-Gault) for patients with creatinine levels &gt; 1.5 X&#xD;
                  institutional ULN&#xD;
&#xD;
               -  AST(SGOT)/ALT(SGPT): ≤ 3.0 × UNL or ≤ 5.0 × UNL (in patients with liver&#xD;
                  metastasis)&#xD;
&#xD;
               -  Alkaline Phosphatase : ≤ 3.0 × UNL or ≤ 5.0 × UNL (in patients with liver or bone&#xD;
                  metastasis)&#xD;
&#xD;
               -  Prothrombin time and partial thromboplastin time : ≤1.5 X ULN&#xD;
&#xD;
          5. Female patient of childbearing potential has a negative serum or urine pregnancy test&#xD;
             within 72 hours prior&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. More than 3 prior cytotoxic agents&#xD;
&#xD;
          2. Patient who has had chemotherapy, radiotherapy, or biological therapy within 2 weeks&#xD;
             prior to entering the study&#xD;
&#xD;
          3. Uncontrolled or active CNS metastasis and/or carcinomatous meningitis&#xD;
&#xD;
          4. Patient has known hypersensitivity to the components of study drugs or its analogs.&#xD;
&#xD;
          5. Patient is pregnant or breastfeeding, or expecting to conceive or father children&#xD;
             within the projected duration of the study.&#xD;
&#xD;
          6. Long QT Syndrome ≥480 ms&#xD;
&#xD;
          7. peripheral neuropathy ≥2 with previous treatment&#xD;
&#xD;
          8. unstable cardiovascular disease&#xD;
&#xD;
          9. Symptomatic interstitial lung disease (ILD) or presence of ILD on chest X-ray&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Severance Hospital, Yonsei University Health System</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>January 16, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>June 14, 2022</last_update_submitted>
  <last_update_submitted_qc>June 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Yonsei University</investigator_affiliation>
    <investigator_full_name>Hyo Song Kim</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leiomyosarcoma</mesh_term>
    <mesh_term>Liposarcoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gemcitabine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03810976
org study id: 4-2017-0933
nct id: NCT03810976
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The eribulin, a microtubule-dynamics inhibitor was approved for specific subtypes of STS.
      Eribulin demonstrated significantly better OS compared to dacarbazine in previously treated
      patients with liposarcoma and leiomyosarcoma and approved as standard treatment. However, the
      median progression free survival (PFS) and response rate (RR) was similar for both groups
      which remains modest outcome of 2.6 months of PFS and 4% of RR. Therefore, to improve
      antitumor activity, further combination strategy is strongly warranted. Based on the previous
      studies, investigators suggest phase II trial of eribulin and gemcitabine combination in
      previously treated patients with unresectable, advanced, or metastatic leiomyosarcoma or
      liposarcoma.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: progression free survival
time frame: 12 weeks
description: To evaluate antitumor efficacy of eribulin and gemcitabine combination
measure: adverse event
time frame: through study completion, an average of 6 months
description: to evaluate safety
arm group label: eribulin+gemcitabine
arm group type: Experimental
description: The dose is 1.4 mg/m2 for 5 minutes intravenously. If necessary, the dose may be diluted in up to 100 mL of saline solution prior to intravenous administration. Gemcitabine doses 1000 mg/m2 intravenously for 30 minutes. After completion of the eribulin injection, intravenously inject gemcitabine. One cycle is 3 weeks, and the treatment is carried out on the 1st day and the 8th day for each cycle.
intervention type: Drug
intervention name: Eribulin, gemcitabine
description: Elibulin 1.4mg/m2 Intravenous for 5minutes. Day 1& Day 8 every 3 weeks Gemcitabine 1000mg/m2 intraveoust for 30 minutes, Day 1& Day 8 every 3 weeks
arm group label: eribulin+gemcitabine
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Yonsei University
investigator full name: Hyo Song Kim
investigator title: professor
mesh term: Leiomyosarcoma
mesh term: Liposarcoma
mesh term: Gemcitabine
sharing ipd: No