<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/NCT01692678</url>
  </required_header>
  <id_info>
    <org_study_id>CR017269</org_study_id>
    <secondary_id>ET743SAR3006</secondary_id>
    <nct_id>NCT01692678</nct_id>
  </id_info>
  <brief_title>A Study of Trabectedin (YONDELIS) in Patients With Locally Advanced or Metastatic Liposarcoma or Leiomyosarcoma</brief_title>
  <official_title>Multicenter, Open-label Study of YONDELIS (Trabectedin) in Subjects With Locally Advanced or Metastatic Liposarcoma or Leiomyosarcoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xian-Janssen Pharmaceutical Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xian-Janssen Pharmaceutical Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to find the optimal dose of trabectedin for Chinese patients&#xD;
      with locally advanced or metastatic L-sarcoma (liposarcoma or leiomyosarcoma) who were&#xD;
      previously treated (in any order) with at least an anthracycline and ifosfamide containing&#xD;
      regimen, or an anthracycline containing regimen and 1 additional cytotoxic chemotherapy&#xD;
      regimen (Part 1) and to evaluate whether the overall survival (OS) of the trabectedin group&#xD;
      is superior to dacarbazine group (Part 2).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is divided into 2 separate parts (ie, Part 1 and Part 2). Part 1 is a dose finding&#xD;
      part (to find the optimal dose) of trabectedin for Chinese patients, and Part 2 is a&#xD;
      multicenter, randomized (the study medication is assigned by chance), active-controlled (an&#xD;
      active substance that is compared with the study medication to test whether the study&#xD;
      medication has a real effect in clinical study), parallel-group (a study comparing the&#xD;
      response in two or more groups of patients receiving different interventions), open-label&#xD;
      (all people know the identity of the intervention) bridging part comparing the efficacy and&#xD;
      safety of the optimal dose of trabectedin with dacarbazine in the same population as in Part&#xD;
      1. The study (in both Part 1 and Part 2) will consist of a screening phase, a treatment phase&#xD;
      and a follow-up phase. Part 1: Optimal dose (ie, maximum tolerated dose [MTD]) is determined&#xD;
      from the following 3 dose levels: Dose level 1 (1.5 mg/m2), Dose level 2 (1.2 mg/m2), and&#xD;
      Dose level 3 (1.0 mg/m2)of trabectedin. Cohorts of 6 patients will be treated at each dose&#xD;
      level. To determine MTD, dose limiting toxicity (DLT; any pre-defined adverse event that&#xD;
      occurs during the first cycle ie, Cycle 1) will be determined. In the first cohort of 6&#xD;
      patients, (a) if DLT is less than or equal to 1 at a dose level, it is considered as MTD (b)&#xD;
      if DLT is greater than 2, patients will be de-escalated to next dose level (c) if DLT is&#xD;
      equal to 2, 3 more patients will be included at that dose level and if there will be no DLT&#xD;
      in those 3 patients, that dose level is considered as MTD. Part 2: If the optimal dose found&#xD;
      in Part 1 is 1.5 mg/m2, approximately 48 patients will be randomly assigned to either the&#xD;
      trabectedin (approximately 32 patients) or dacarbazine (approximately 16 patients) treatment&#xD;
      group in Part 2. If the optimal dose found in Part 1 is below 1.5 mg/m2, 123 patients will be&#xD;
      randomly assigned to either the trabectedin (approximately 82 patients) or dacarbazine&#xD;
      (approximately 41 patients) treatment group. Safety will be evaluated by assessing adverse&#xD;
      events, clinical laboratory test, multiple gated acquisition scans, electrocardiograms, vital&#xD;
      signs, and physical examination throughout the study up to 30 days after the end of&#xD;
      treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 7, 2012</start_date>
  <completion_date type="Actual">October 11, 2016</completion_date>
  <primary_completion_date type="Actual">October 11, 2016</primary_completion_date>
  <phase>Phase 3</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>Part 1: Optimal dose level (Maximum tolerated dose [MTD]) of trabectidin</measure>
    <time_frame>From the date of dosing until 21days after the date of last patient enrolled</time_frame>
    <description>MTD (1.5, 1.2 or 1.0 mg/m2) is determined by assessing Dose Limiting Toxicity (DLT).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: Overall survival</measure>
    <time_frame>From the date of dosing upto 18 months after the last patient enrollment or 30 days after the last dose of study medication has been administered, whichever will be later</time_frame>
    <description>Patients will be monitored for survival status at least every 60 days for the first 2 years after the last dose of study drug and every 90 days thereafter.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2: Overall survival</measure>
    <time_frame>From the date of randomization until the required number of events has occurred (approximately 32 if 1.5mg/m2, or 82 with below 1.5mg/m2) as assessed approximately for 6 months after the last patient enrollment</time_frame>
    <description>Patients will be monitored for survival status at least every 60 days for the first 2 years after the last dose of study drug and every 90 days thereafter.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Part 1: Progression free survival (PFS)</measure>
    <time_frame>From date of dosing until the date of first documented progression or date of death from any cause, whichever comes first, as assessed up to 18 months after the last patient enrollment</time_frame>
    <description>PFS is defined as the time from dosing to the occurrence of disease progression or death, whichever occurs first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2: Progression free survival (PFS)</measure>
    <time_frame>From the date of randomization till the first documented disease progression or death whichever comes first until the required number of events, estimate of 6 months after the last patient enrollment</time_frame>
    <description>PFS is defined as the time from randomization to the occurrence of disease progression or death, whichever occurs first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 1: Time-to-progression (TTP)</measure>
    <time_frame>From date of dosing until the date of first documented progression or date of death from any cause, whichever comes first, as assessed up to 18 months after the last patient enrollment</time_frame>
    <description>Time-to-progression (TTP) is defined as the time between dosing and disease progression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2: Time-to-progression (TTP)</measure>
    <time_frame>From the date of randomization till the first documented disease progression or death whichever comes first until the required number of events, estimate of 6 months after the last patient enrollment</time_frame>
    <description>Time-to-progression (TTP) is defined as the time between randomization and disease progression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 1: Objective Response Rate (ORR)</measure>
    <time_frame>From date of dosing until the date of best response, as assessed up to 18 months after the last patient enrollment</time_frame>
    <description>Objective Response Rate (ORR) is defined as having complete response or partial response as best overall response based on reconciled radiographic disease assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2: Objective Response Rate (ORR)</measure>
    <time_frame>From date of dosing until the date of best response, as assessed up to 6 months after the last patient enrollment</time_frame>
    <description>Objective Response Rate (ORR) is defined as having complete response or partial response as best overall response based on reconciled radiographic disease assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 1: Duration of response (DR)</measure>
    <time_frame>From date of dosing until the date of first documented progression or date of death from any cause, whichever comes first, as assessed approximately up to 18 months after the last patient enrollment</time_frame>
    <description>Duration of response (DR) is defined only for patients who have CR or PR as best overall response and is calculated from the date of the first documentation of response to the date of disease progression or death, whichever occurs first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2: Duration of response (DR)</measure>
    <time_frame>From the date of randomization till the first documented disease progression or death whichever comes first, assessed approximately up to 6 months after the last patient enrollment</time_frame>
    <description>Duration of response (DR) is defined only for patients who have CR or PR as best overall response and is calculated from the date of the first documentation of response to the date of disease progression or death, whichever occurs first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 1: Observed maximum plasma concentration (Cmax)</measure>
    <time_frame>Days 1, 2, 3, 4, 5, 8 of first 2 treatment cycles</time_frame>
    <description>Pharmacokinetic parameter Cmax of trabectedin will be determined</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 1: Area under the plasma concentration-time curve (AUC)</measure>
    <time_frame>Days 1, 2, 3, 4, 5, 8 of first 2 treatment cycles</time_frame>
    <description>Pharmacokinetic parameter AUC of trabectedin will be determined.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Advanced or Metastatic Liposarcoma or Leiomyosarcoma</condition>
  <arm_group>
    <arm_group_label>Trabectedin (Part 1 and Part 2)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Trabectedin will be administered at a dose of 1.5, 1.2 or 1.0 mg/m2 as a 24-hour intravenous infusion on Day 1 of each 21-day treatment cycle (ie, each treatment cycle being at least 21 days apart).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dacarbazine (Part 2)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Dacarbazine will be administered at a dose of 1 g/m2 as a longer than 30-minute intravenous infusion on Day 1 of each 21-day treatment cycle (ie, each treatment cycle being at least 21 days apart).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Trabectedin</intervention_name>
    <description>Type=exact number, unit=mg/m2, number=1.5, 1.2 or 1.0, form=solution, route=intravenous infusion. Trabectedin will be administered on Day 1 of each 21-day treatment cycle.</description>
    <arm_group_label>Trabectedin (Part 1 and Part 2)</arm_group_label>
    <other_name>YONDELIS</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dacarbazine</intervention_name>
    <description>Type=exact number, unit=g/m2, number=1, form=solution, route=intravenous infusion. Dacarbazine will be administered on Day 1 of each 21-day treatment cycle.</description>
    <arm_group_label>Dacarbazine (Part 2)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically proven, unresectable, locally advanced or metastatic liposarcoma or&#xD;
             leiomyosarcoma&#xD;
&#xD;
          -  Treated in any order with at least: an anthracycline and ifosfamide containing&#xD;
             regimen, or an anthracycline containing regimen and 1 additional cytotoxic&#xD;
             chemotherapy regimen&#xD;
&#xD;
          -  Measurable disease at baseline in accordance with Response Evaluation Criteria in&#xD;
             Solid Tumors (RECIST) criteria&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1&#xD;
&#xD;
          -  Adequate recovery from prior therapy; all side effects (except alopecia) have resolved&#xD;
             to Grade 1 or less according to the National Cancer Institute&#xD;
&#xD;
          -  Adequate organ function and hepatic function&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior exposure to trabectedin (both Part 1 and Part 2) or dacarbazine (Only Part 2)&#xD;
&#xD;
          -  Less than 3 weeks from last dose of systemic cytotoxic therapy, radiation therapy, or&#xD;
             therapy with any investigational agent&#xD;
&#xD;
          -  Other malignancy within past 3 years (exceptions: basal or nonmetastatic squamous cell&#xD;
             carcinoma of the skin, cervical carcinoma in situ, or Federation Internationale de&#xD;
             Gynecologie et d'Obstetrique (FIGO) Stage 1 carcinoma of the cervix)&#xD;
&#xD;
          -  Known central nervous system metastasis&#xD;
&#xD;
          -  Active or symptomatic viral hepatitis or chronic liver disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xian-Janssen Pharmaceutical Ltd., China Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Xian-Janssen Pharmaceutical Ltd.</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <link>
    <url>http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_7051&amp;studyid=2432&amp;filename=CR017269_CSR.pdf</url>
    <description>Multicenter, Open-label Study of YONDELIS (Trabectedin) in Subjects With Locally Advanced or Metastatic Liposarcoma or Leiomyosarcoma</description>
  </link>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>August 6, 2012</study_first_submitted>
  <study_first_submitted_qc>September 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <last_update_submitted>July 9, 2018</last_update_submitted>
  <last_update_submitted_qc>July 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Advanced or Metastatic liposarcoma or leiomyosarcoma</keyword>
  <keyword>Sarcoma</keyword>
  <keyword>L-sarcoma</keyword>
  <keyword>Liposarcoma</keyword>
  <keyword>Leiomyosarcoma</keyword>
  <keyword>Trabectedin</keyword>
  <keyword>Dacarbazine</keyword>
  <keyword>Yondelis</keyword>
  <keyword>Chinese patients</keyword>
  <keyword>Overall survival</keyword>
  <keyword>Pharmacokinetics</keyword>
  <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>Dacarbazine</mesh_term>
    <mesh_term>Trabectedin</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/NCT01692678
org study id: CR017269
secondary id: ET743SAR3006
nct id: NCT01692678
lead sponsor: 
has dmc: No
The purpose of this study is to find the optimal dose of trabectedin for Chinese patients
      with locally advanced or metastatic L-sarcoma (liposarcoma or leiomyosarcoma) who were
      previously treated (in any order) with at least an anthracycline and ifosfamide containing
      regimen, or an anthracycline containing regimen and 1 additional cytotoxic chemotherapy
      regimen (Part 1) and to evaluate whether the overall survival (OS) of the trabectedin group
      is superior to dacarbazine group (Part 2).
The study is divided into 2 separate parts (ie, Part 1 and Part 2). Part 1 is a dose finding
      part (to find the optimal dose) of trabectedin for Chinese patients, and Part 2 is a
      multicenter, randomized (the study medication is assigned by chance), active-controlled (an
      active substance that is compared with the study medication to test whether the study
      medication has a real effect in clinical study), parallel-group (a study comparing the
      response in two or more groups of patients receiving different interventions), open-label
      (all people know the identity of the intervention) bridging part comparing the efficacy and
      safety of the optimal dose of trabectedin with dacarbazine in the same population as in Part
      1. The study (in both Part 1 and Part 2) will consist of a screening phase, a treatment phase
      and a follow-up phase. Part 1: Optimal dose (ie, maximum tolerated dose [MTD]) is determined
      from the following 3 dose levels: Dose level 1 (1.5 mg/m2), Dose level 2 (1.2 mg/m2), and
      Dose level 3 (1.0 mg/m2)of trabectedin. Cohorts of 6 patients will be treated at each dose
      level. To determine MTD, dose limiting toxicity (DLT; any pre-defined adverse event that
      occurs during the first cycle ie, Cycle 1) will be determined. In the first cohort of 6
      patients, (a) if DLT is less than or equal to 1 at a dose level, it is considered as MTD (b)
      if DLT is greater than 2, patients will be de-escalated to next dose level (c) if DLT is
      equal to 2, 3 more patients will be included at that dose level and if there will be no DLT
      in those 3 patients, that dose level is considered as MTD. Part 2: If the optimal dose found
      in Part 1 is 1.5 mg/m2, approximately 48 patients will be randomly assigned to either the
      trabectedin (approximately 32 patients) or dacarbazine (approximately 16 patients) treatment
      group in Part 2. If the optimal dose found in Part 1 is below 1.5 mg/m2, 123 patients will be
      randomly assigned to either the trabectedin (approximately 82 patients) or dacarbazine
      (approximately 41 patients) treatment group. Safety will be evaluated by assessing adverse
      events, clinical laboratory test, multiple gated acquisition scans, electrocardiograms, vital
      signs, and physical examination throughout the study up to 30 days after the end of
      treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Part 1: Optimal dose level (Maximum tolerated dose [MTD]) of trabectidin
time frame: From the date of dosing until 21days after the date of last patient enrolled
description: MTD (1.5, 1.2 or 1.0 mg/m2) is determined by assessing Dose Limiting Toxicity (DLT).
measure: Part 1: Overall survival
time frame: From the date of dosing upto 18 months after the last patient enrollment or 30 days after the last dose of study medication has been administered, whichever will be later
description: Patients will be monitored for survival status at least every 60 days for the first 2 years after the last dose of study drug and every 90 days thereafter.
measure: Part 2: Overall survival
time frame: From the date of randomization until the required number of events has occurred (approximately 32 if 1.5mg/m2, or 82 with below 1.5mg/m2) as assessed approximately for 6 months after the last patient enrollment
description: Patients will be monitored for survival status at least every 60 days for the first 2 years after the last dose of study drug and every 90 days thereafter.
measure: Part 1: Progression free survival (PFS)
time frame: From date of dosing until the date of first documented progression or date of death from any cause, whichever comes first, as assessed up to 18 months after the last patient enrollment
description: PFS is defined as the time from dosing to the occurrence of disease progression or death, whichever occurs first.
measure: Part 2: Progression free survival (PFS)
time frame: From the date of randomization till the first documented disease progression or death whichever comes first until the required number of events, estimate of 6 months after the last patient enrollment
description: PFS is defined as the time from randomization to the occurrence of disease progression or death, whichever occurs first.
measure: Part 1: Time-to-progression (TTP)
time frame: From date of dosing until the date of first documented progression or date of death from any cause, whichever comes first, as assessed up to 18 months after the last patient enrollment
description: Time-to-progression (TTP) is defined as the time between dosing and disease progression.
measure: Part 2: Time-to-progression (TTP)
time frame: From the date of randomization till the first documented disease progression or death whichever comes first until the required number of events, estimate of 6 months after the last patient enrollment
description: Time-to-progression (TTP) is defined as the time between randomization and disease progression.
measure: Part 1: Objective Response Rate (ORR)
time frame: From date of dosing until the date of best response, as assessed up to 18 months after the last patient enrollment
description: Objective Response Rate (ORR) is defined as having complete response or partial response as best overall response based on reconciled radiographic disease assessment.
measure: Part 2: Objective Response Rate (ORR)
time frame: From date of dosing until the date of best response, as assessed up to 6 months after the last patient enrollment
description: Objective Response Rate (ORR) is defined as having complete response or partial response as best overall response based on reconciled radiographic disease assessment.
measure: Part 1: Duration of response (DR)
time frame: From date of dosing until the date of first documented progression or date of death from any cause, whichever comes first, as assessed approximately up to 18 months after the last patient enrollment
description: Duration of response (DR) is defined only for patients who have CR or PR as best overall response and is calculated from the date of the first documentation of response to the date of disease progression or death, whichever occurs first.
measure: Part 2: Duration of response (DR)
time frame: From the date of randomization till the first documented disease progression or death whichever comes first, assessed approximately up to 6 months after the last patient enrollment
description: Duration of response (DR) is defined only for patients who have CR or PR as best overall response and is calculated from the date of the first documentation of response to the date of disease progression or death, whichever occurs first.
measure: Part 1: Observed maximum plasma concentration (Cmax)
time frame: Days 1, 2, 3, 4, 5, 8 of first 2 treatment cycles
description: Pharmacokinetic parameter Cmax of trabectedin will be determined
measure: Part 1: Area under the plasma concentration-time curve (AUC)
time frame: Days 1, 2, 3, 4, 5, 8 of first 2 treatment cycles
description: Pharmacokinetic parameter AUC of trabectedin will be determined.
arm group label: Trabectedin (Part 1 and Part 2)
arm group type: Experimental
description: Trabectedin will be administered at a dose of 1.5, 1.2 or 1.0 mg/m2 as a 24-hour intravenous infusion on Day 1 of each 21-day treatment cycle (ie, each treatment cycle being at least 21 days apart).
arm group label: Dacarbazine (Part 2)
arm group type: Active Comparator
description: Dacarbazine will be administered at a dose of 1 g/m2 as a longer than 30-minute intravenous infusion on Day 1 of each 21-day treatment cycle (ie, each treatment cycle being at least 21 days apart).
intervention type: Drug
intervention name: Trabectedin
description: Type=exact number, unit=mg/m2, number=1.5, 1.2 or 1.0, form=solution, route=intravenous infusion. Trabectedin will be administered on Day 1 of each 21-day treatment cycle.
arm group label: Trabectedin (Part 1 and Part 2)
other name: YONDELIS
intervention type: Drug
intervention name: Dacarbazine
description: Type=exact number, unit=g/m2, number=1, form=solution, route=intravenous infusion. Dacarbazine will be administered on Day 1 of each 21-day treatment cycle.
arm group label: Dacarbazine (Part 2)
criteria: 
gender: All
minimum age: 15 Years
maximum age: N/A
healthy volunteers: No
last name: Xian-Janssen Pharmaceutical Ltd., China Clinical Trial
role: Study Director
affiliation: Xian-Janssen Pharmaceutical Ltd.
facility: 
facility: 
country: China
url: http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_7051&studyid=2432&filename=CR017269_CSR.pdf
description: Multicenter, Open-label Study of YONDELIS (Trabectedin) in Subjects With Locally Advanced or Metastatic Liposarcoma or Leiomyosarcoma
responsible party type: Sponsor
mesh term: Leiomyosarcoma
mesh term: Liposarcoma
mesh term: Dacarbazine
mesh term: Trabectedin