<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/NCT02211222</url>
  </required_header>
  <id_info>
    <org_study_id>E7080-G000-398</org_study_id>
    <nct_id>NCT02211222</nct_id>
  </id_info>
  <brief_title>An Expanded Access Program With Lenvatinib for the Treatment of Radioiodine-Refractory Differentiated Thyroid Cancer</brief_title>
  <official_title>An Open-Label, Randomized, Multicenter, Expanded Access Program With Lenvatinib for the Treatment of Radioiodine-Refractory Differentiated Thyroid Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eisai Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eisai Inc.</source>
  <brief_summary>
    <textblock>
      This Expanded Access Program (EAP) consists of a Prerandomization Phase and a Randomization&#xD;
      Phase. Only subjects with radioiodine-refractory DTC who fulfill the eligibility criteria&#xD;
      will be treated. These subjects will be treated until progression of disease or unacceptable&#xD;
      toxicity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Approved for marketing</overall_status>
  <completion_date type="Anticipated">June 2015</completion_date>
  <primary_completion_date type="Anticipated">August 2015</primary_completion_date>
  <study_type>Expanded Access</study_type>
  <condition>Differentiated Thyroid Cancer</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lenvatinib</intervention_name>
    <description>Lenvatinib at starting doses of 24-mg, 20-mg, or 14-mg will be administered as a combination of 10-mg capsules and 4-mg capsules to be taken once a day (QD) (recommended to be taken the same time each day). Subjects will receive one of three starting doses of lenvatinib, 24-mg/day, 20-mg/day, or 14-mg/day. Dose reductions occur in succession based on the previous dose level (24, 20, 14, and 10 mg/day). Any dose reduction below 10 mg/day must be discussed with the sponsor. Once the dose has been reduced, it cannot be increased at a later date.</description>
    <other_name>E7080</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          1. Subjects must have histologically or cytologically confirmed diagnoses of one of the&#xD;
             following DTC subtypes: a. Papillary thyroid cancer (PTC) i. Follicular variant ii.&#xD;
             Variants (including but not limited to: tall cell, columnar cell, cribriform-morular,&#xD;
             solid, oxyphil, Warthin's-like, trabecular, tumor with nodular fasciitis-like stroma,&#xD;
             Hurthle cell variant of papillary carcinoma, poorly differentiated); b.Follicular&#xD;
             thyroid cancer (FTC) i. Hurthle cell ii. Clear cell iii.Insular&#xD;
&#xD;
          2. Subjects must be radioiodine-refractory or resistant within 12 months of radioiodine&#xD;
             therapy and have one of the following:&#xD;
&#xD;
               1. One or more lesions that do not demonstrate iodine uptake on any radioiodine scan&#xD;
&#xD;
               2. One or more lesions that have substantially increased in size within 12 months of&#xD;
                  radioiodine therapy, despite demonstration of radioiodine activity at the time of&#xD;
                  that treatment by pre- or posttreatment scanning&#xD;
&#xD;
               3. Cumulative activity of radioiodine of greater than 600 mCi or 22 gigabecquerels&#xD;
                  (GBq), with the last dose administered at least 6 months prior to study entry&#xD;
&#xD;
          3. Subjects must have received and failed treatment with sorafenib for RR-DTC. This&#xD;
             criterion will not apply outside the United States if sorafenib is not commercially&#xD;
             available in the country where the subject resides.&#xD;
&#xD;
          4. ECOG performance status of 0 to 2&#xD;
&#xD;
          5. Blood pressure (BP) less than or equal to 150/90 mmHg at screening with or without&#xD;
             antihypertensive medications and no change in antihypertensive medications within 1&#xD;
             week prior to Cycle 1 Day 1&#xD;
&#xD;
          6. Creatinine clearance greater than or equal to 30 mL/min according to the Cockcroft and&#xD;
             Gault formula&#xD;
&#xD;
          7. Adequate bone marrow function&#xD;
&#xD;
               -  Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10^9/L&#xD;
&#xD;
               -  Hemoglobin greater than or equal to 9.0 g/dL (can be corrected by growth factor&#xD;
                  or transfusion)&#xD;
&#xD;
               -  Platelet count greater than or equal to 100 x 10^9/L&#xD;
&#xD;
          8. Adequate liver function&#xD;
&#xD;
               -  Bilirubin less than or equal to 1.5 x upper limit of normal (ULN) except for&#xD;
                  unconjugated hyperbilirubinemia or Gilbert's syndrome&#xD;
&#xD;
               -  Alkaline phosphatase (ALP), alanine aminotransferase (ALT), and aspartate&#xD;
                  aminotransferase (AST) less than or equal to 3 x ULN (less than or equal to 5 x&#xD;
                  ULN if subject has liver metastases). If ALP is greater than 3 x ULN (in the&#xD;
                  absence of liver metastases) or greater than 5 x ULN (in the presence of liver&#xD;
                  metastases) AND subjects are also known to have bone metastases, the&#xD;
                  liver-specific ALP must be separated from the total and used to assess the liver&#xD;
                  function instead of the total ALP&#xD;
&#xD;
          9. Provide written informed consent&#xD;
&#xD;
         10. Males and females age greater than or equal to 18 years at the time of informed&#xD;
             consent&#xD;
&#xD;
         11. All females must have a negative serum or urine pregnancy test. Females of&#xD;
             childbearing potential and male subjects who are partners of women of childbearing&#xD;
             potential must use or their partners must use a highly effective method of&#xD;
             contraception&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          1. Subjects having greater than 1+ proteinuria on urine dipstick at screening testing&#xD;
             will undergo 24 h urine collection for quantitative assessment of proteinuria.&#xD;
             Subjects with urine protein greater than or equal to 1 g/24 h will be ineligible.&#xD;
&#xD;
          2. History of congestive heart failure with New York Heart Association (NYHA)&#xD;
             Classification greater than II, unstable angina, myocardial infarction, serious&#xD;
             cardiac arrhythmia, or stroke within the past 6 months&#xD;
&#xD;
          3. Electrocardiogram (ECG) with QT interval (QTc) interval greater than or equal to 480&#xD;
             msec&#xD;
&#xD;
          4. Existing anti-cancer therapy-related toxicities of grade greater than or equal to 2,&#xD;
             except alopecia and infertility&#xD;
&#xD;
          5. History of intolerance to or progression on prior treatment with lenvatinib that led&#xD;
             to the discontinuation of lenvatinib&#xD;
&#xD;
          6. Any history of or concomitant medical condition that, in the opinion of the&#xD;
             investigator, would compromise subject's ability to safely complete the protocol&#xD;
&#xD;
          7. Females who are pregnant (positive B-hCG test) or breastfeeding&#xD;
&#xD;
          8. Eligible for any other lenvatinib study that is open for recruitment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lansing</city>
        <state>Michigan</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Neptune</city>
        <state>New Jersey</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>August 5, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 7, 2014</study_first_posted>
  <last_update_submitted>March 15, 2016</last_update_submitted>
  <last_update_submitted_qc>March 15, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 16, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Thyroid Cancer</keyword>
  <keyword>Radioiodine-Refractory</keyword>
  <keyword>Differentiated</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thyroid Neoplasms</mesh_term>
    <mesh_term>Thyroid Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT02211222
org study id: E7080-G000-398
nct id: NCT02211222
lead sponsor: 
This Expanded Access Program (EAP) consists of a Prerandomization Phase and a Randomization
      Phase. Only subjects with radioiodine-refractory DTC who fulfill the eligibility criteria
      will be treated. These subjects will be treated until progression of disease or unacceptable
      toxicity.
intervention type: Drug
intervention name: Lenvatinib
description: Lenvatinib at starting doses of 24-mg, 20-mg, or 14-mg will be administered as a combination of 10-mg capsules and 4-mg capsules to be taken once a day (QD) (recommended to be taken the same time each day). Subjects will receive one of three starting doses of lenvatinib, 24-mg/day, 20-mg/day, or 14-mg/day. Dose reductions occur in succession based on the previous dose level (24, 20, 14, and 10 mg/day). Any dose reduction below 10 mg/day must be discussed with the sponsor. Once the dose has been reduced, it cannot be increased at a later date.
other name: E7080
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
facility: 
facility: 
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country: United States
responsible party type: Sponsor
mesh term: Thyroid Neoplasms
mesh term: Thyroid Diseases
mesh term: Lenvatinib