<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/NCT03005015</url>
  </required_header>
  <id_info>
    <org_study_id>EORTC-1528</org_study_id>
    <nct_id>NCT03005015</nct_id>
  </id_info>
  <brief_title>Lenvatinib in Second Line Endometrial Carcinoma</brief_title>
  <official_title>A Randomized Phase II Study of Lenvatinib Versus Doxorubicin in Second Line Advanced or Recurrent Endometrial Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>European Organisation for Research and Treatment of Cancer - EORTC</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>European Organisation for Research and Treatment of Cancer - EORTC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this multicenter, randomized phase II trial is to assess the&#xD;
      efficacy, as measured by progression-free survival (PFS), of lenvatinib compared to&#xD;
      doxorubicin in advanced or recurrent endometrial cancer.&#xD;
&#xD;
      The main secondary objective is to evaluate the predictive value of Ang-2 on lenvatinib&#xD;
      activity and establishing a cutoff value as potential selection criteria for phase III.&#xD;
&#xD;
      Other secondary objectives are to assess the tolerability and safety of lenvatinib in this&#xD;
      setting and overall survival, response and disease control.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    supporting company (Eisai) withdrew their interest&#xD;
  </why_stopped>
  <start_date>January 2017</start_date>
  <primary_completion_date type="Anticipated">July 2020</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 (PFS)</measure>
    <time_frame>2.5 years</time_frame>
    <description>PFS assessed by Response Evaluation Criteria in Solid Tumors (RECIST</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Endometrial Neoplasms</condition>
  <arm_group>
    <arm_group_label>Lenvatinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lenvatinib 24 mg orally every day. Treatment is continued until unacceptable toxicity, progressive disease or patient withdrawal</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Doxorubicin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Doxorubicin 60 mg/m² iv bolus every 3 weeks. Treatment is continued for a maximum of 6 cycles or until unacceptable toxicity, progressive disease or patient withdrawal.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lenvatinib</intervention_name>
    <arm_group_label>Lenvatinib</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Doxorubicin</intervention_name>
    <arm_group_label>Doxorubicin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female subjects age ≥18 years at the time of informed consent&#xD;
&#xD;
          -  World Health Organization (WHO) Performance Status of 0 or 1&#xD;
&#xD;
          -  Patients with histologically confirmed endometrial cancer including serous-papillary&#xD;
             and clear cell histologies. Uterine carcinosarcomas are allowed.&#xD;
&#xD;
          -  Radiographic evidence of disease progression according to RECIST 1.1 after 1 prior&#xD;
             systemic, platinum-based chemotherapy regimen for metastatic or primary unresectable&#xD;
             endometrial carcinoma for which no surgical or radiotherapy treatment options exist.&#xD;
&#xD;
          -  Patients with disease progression following platinum-based chemotherapy administered&#xD;
             as either adjuvant or neoadjuvant treatment are also eligible.&#xD;
&#xD;
          -  Patients may have received prior radiotherapy and / or adjuvant chemotherapy for early&#xD;
             high-risk disease&#xD;
&#xD;
          -  Patients may not have received prior treatment with anthracyclines&#xD;
&#xD;
          -  Blood samples available for retrospective central assessment of Ang-2 level&#xD;
&#xD;
          -  Patients may have had prior therapy providing the following conditions are met:&#xD;
&#xD;
          -  Surgery and radiation therapy: wash-out period of 14 days and subjects must have&#xD;
             recovered adequately from any toxicity and/or complications from radiotherapy and&#xD;
             major surgery prior to starting therapy.&#xD;
&#xD;
          -  Systemic anti-tumor therapy or any investigational agent: wash-out period of 21 days&#xD;
             (or 5 x half-life)&#xD;
&#xD;
          -  Recovery from any toxic effects of prior therapy to ≤ Grade 1 per the National Cancer&#xD;
             Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v4.) except&#xD;
             alopecia&#xD;
&#xD;
          -  Adequate contraceptive measures&#xD;
&#xD;
          -  Signed written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inadequate hematologic, renal and hepatic functions&#xD;
&#xD;
          -  Abnormal cardiac function&#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>Antonio Casado</last_name>
    <role>Study Chair</role>
    <affiliation>Hospital Universitario San Carlos, Madrid, Spain</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Vaudois</name>
      <address>
        <city>Lausanne</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>August 18, 2016</study_first_submitted>
  <study_first_submitted_qc>December 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <last_update_submitted>December 23, 2016</last_update_submitted>
  <last_update_submitted_qc>December 23, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endometrial Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Doxorubicin</mesh_term>
    <mesh_term>Lenvatinib</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/NCT03005015
org study id: EORTC-1528
nct id: NCT03005015
lead sponsor: 
has dmc: Yes
The primary objective of this multicenter, randomized phase II trial is to assess the
      efficacy, as measured by progression-free survival (PFS), of lenvatinib compared to
      doxorubicin in advanced or recurrent endometrial cancer.

      The main secondary objective is to evaluate the predictive value of Ang-2 on lenvatinib
      activity and establishing a cutoff value as potential selection criteria for phase III.

      Other secondary objectives are to assess the tolerability and safety of lenvatinib in this
      setting and overall survival, response and disease control.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression free survival (PFS)
time frame: 2.5 years
description: PFS assessed by Response Evaluation Criteria in Solid Tumors (RECIST
arm group label: Lenvatinib
arm group type: Experimental
description: Lenvatinib 24 mg orally every day. Treatment is continued until unacceptable toxicity, progressive disease or patient withdrawal
arm group label: Doxorubicin
arm group type: Active Comparator
description: Doxorubicin 60 mg/m² iv bolus every 3 weeks. Treatment is continued for a maximum of 6 cycles or until unacceptable toxicity, progressive disease or patient withdrawal.
intervention type: Drug
intervention name: Lenvatinib
arm group label: Lenvatinib
intervention type: Drug
intervention name: Doxorubicin
arm group label: Doxorubicin
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Antonio Casado
role: Study Chair
affiliation: Hospital Universitario San Carlos, Madrid, Spain
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Endometrial Neoplasms
mesh term: Doxorubicin
mesh term: Lenvatinib