<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/NCT04447755</url>
  </required_header>
  <id_info>
    <org_study_id>7902-013</org_study_id>
    <secondary_id>MK-7902-013</secondary_id>
    <secondary_id>2019-004441-33</secondary_id>
    <nct_id>NCT04447755</nct_id>
  </id_info>
  <brief_title>A Study of Lenvatinib (MK-7902) in Pediatric Participants With Relapsed or Refractory Solid Malignancies (MK-7902-013/E7080)</brief_title>
  <acronym>E7080-G000-231</acronym>
  <official_title>An Open-Label, Multicenter Phase 2 Basket Study to Evaluate the Antitumor Activity and Safety of Lenvatinib in Children, Adolescents, and Young Adults With Relapsed or Refractory Solid Malignancies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eisai Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Merck Sharp &amp; Dohme LLC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purpose of this study is to evaluate the antitumor activity and safety of Lenvatinib&#xD;
      (MK-7902/E7080) in children, adolescents, and young adults with relapsed or refractory solid&#xD;
      malignancies after administration. Participants will be enrolled into initial tumor-specific&#xD;
      cohorts which will be expanded based on observed response.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 30, 2020</start_date>
  <completion_date type="Anticipated">February 19, 2024</completion_date>
  <primary_completion_date type="Actual">September 16, 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>
    <masking_description>Open Label</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Objective Response Rate (ORR) At Week 16 per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) or Response Assessment in Neuro-Oncology (RANO) Criteria (for High Grade Glioma [HGG] only), by Investigator Assessment</measure>
    <time_frame>Week 16 of treatment</time_frame>
    <description>ORR at Week 16 is defined as the percentage of participants with a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters [SOD] of target lesions, taking as reference the baseline SOD) as assessed by the investigator per RECIST 1.1 at 16 Weeks. For participants with HGG, response is assessed according to RANO criteria whereby overall response is based on both radiographic response (CR: disappearance of all target lesions, PR: sum of products of diameters [SPD] decreased by ≥ 50% from baseline value) and clinical performance status with steroid dose information.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ORR per RECIST 1.1 or RANO Criteria (for HGG only), by Investigator Assessment</measure>
    <time_frame>Up to approximately 43 months</time_frame>
    <description>ORR is defined as the percentage of participants with a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD) as assessed by the investigator per RECIST 1.1. For participants with HGG, response will be assessed according to RANO criteria whereby overall RANO response is based on both radiographic response (CR: disappearance of all target lesions, PR: SPD decreased by ≥ 50% from baseline value) and clinical performance status with steroid dose information.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival (PFS) per RECIST 1.1 or RANO (for HGG only), by Investigator Assessment</measure>
    <time_frame>Up to approximately 43 months</time_frame>
    <description>PFS is defined as the time from the date of the first administration of study drug until the date of first documentation of progressive disease (PD) per RECIST 1.1 or RANO (for HGG) or death (whichever occurs first).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Best Overall Response (BOR) per RECIST 1.1 or RANO (for HGG only), by Investigator Assessment</measure>
    <time_frame>Up to approximately 43 months</time_frame>
    <description>BOR is defined as the participant's best confirmed response (CR or PR) over the treatment period as assessed by the investigator per RECIST 1.1 or RANO. As per RECIST 1.1, CR is defined as disappearance of all target lesions and PR is defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. For participants with HGG, response will be assessed according to RANO criteria whereby overall RANO response is based on both radiographic response (CR: disappearance of all target lesions, PR: SPD decreased by ≥ 50% from baseline value) and clinical performance status with steroid dose information.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response (DOR) per RECIST 1.1 or RANO (for HGG only), by Investigator Assessment</measure>
    <time_frame>Up to approximately 43 months</time_frame>
    <description>DOR defined as the time from the date of the first documented CR or PR to the date first documentation of progressive disease or death (whichever occurs first). As per RECIST 1.1, CR is defined as disappearance of all target lesions and PR is defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. For participants with HGG, response will be assessed according to RANO criteria whereby overall RANO response is based on both radiographic response (CR: disappearance of all target lesions, PR: SPD decreased by ≥ 50% from baseline value) and clinical performance status with steroid dose information.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Control Rate (DCR) per RECIST 1.1 or RANO (for HGG only), by Investigator Assessment</measure>
    <time_frame>Up to approximately 43 months</time_frame>
    <description>DCR is defined as a BOR of CR or PR, or stable disease (SD). To be assigned a BOR of SD, the time from the first administration of study drug until the date of documented SD should be ≥7 weeks. As per RECIST 1.1, CR is defined as disappearance of all target lesions, PR is defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, and SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. For participants with HGG, response is assessed according to RANO criteria whereby overall response is based on both radiographic response (CR: disappearance of all target lesions, PR: SPD decreased by ≥ 50% from baseline value and SD: SPD &lt;50% decreased from baseline, but &lt;25% increased from nadir) and clinical performance status with steroid dose information.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Benefit Rate (CBR) per RECIST 1.1 or RANO (for HGG only), by Investigator Assessment</measure>
    <time_frame>Up to approximately 43 months</time_frame>
    <description>CBR is defined as a BOR of CR or PR, or durable SD (Duration of SD should be ≥23 weeks since the first dose of the study treatment. As per RECIST 1.1, CR is defined as disappearance of all target lesions, PR is defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD and SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. For participants with HGG, response is assessed according to RANO criteria whereby overall response is based on both radiographic response (CR: disappearance of all target lesions, PR: SPD decreased by ≥ 50% from baseline value and SD: SPD &lt;50% decreased from baseline, but &lt;25% increased from nadir) and clinical performance status with steroid dose information.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants who Experience an Adverse Event (AE)</measure>
    <time_frame>Up to approximately 43 months</time_frame>
    <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experience at least one AE will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants who Discontinue Study Treatment Due to an AE</measure>
    <time_frame>Up to approximately 43 months</time_frame>
    <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinue study treatment due to an AE will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Palatability Questionnaire Score For Lenvatinib Suspension Formulation</measure>
    <time_frame>Cycle 1 Day 1 (cycle = 28 days)</time_frame>
    <description>A hedonic Visual Analog Scale (VAS) will be used to assess taste likability or &quot;palatability&quot; of a lenvatinib suspension formulated with water. Palatability will be rated based on 5 categories: taste, appearance, smell, mouth feel, and overall acceptability. Participants will score each category on a scale from 1-7 ranging from super bad (score = 1) to super good (score = 7). The VAS hedonic scale scores will be summarized using descriptive statistics for each cohort and the median score will be reported for each palatability category.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Concentration-Time Curve of lenvatinib From Time 0 to Infinity (AUC 0-inf)</measure>
    <time_frame>At designated time points on Cycle 1 Day 1 (post-dose), Cycle 1 Day 15 (pre-dose and post-dose), and Cycle 2 Day 1 (pre-dose and post-dose). A cycle is 28 days.</time_frame>
    <description>Blood samples taken predose and at specified times postdose on Days 1-28 to determine the AUC 0-inf of Lenvatinib.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">127</enrollment>
  <condition>Relapsed or Refractory Solid Tumors</condition>
  <arm_group>
    <arm_group_label>Lenvatinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive lenvatinib 14 mg/m^2 once daily (QD) orally until progressive disease or unacceptable toxicity (up to approximately 1 year).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lenvatinib</intervention_name>
    <description>Lenvatinib capsules administered orally at 14 mg/m^2 QD</description>
    <arm_group_label>Lenvatinib</arm_group_label>
    <other_name>MK-7902</other_name>
    <other_name>E7080</other_name>
    <other_name>LENVIMA</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Has histologically or cytologically documented relapsed, or refractory pediatric solid&#xD;
             malignancy excluding osteosarcoma&#xD;
&#xD;
          -  Has measurable disease as defined by Response Evaluation Criteria In Solid Tumors&#xD;
             version 1.1 (RECIST 1.1) or Response Assessment in Neuro-Oncology (RANO) for High&#xD;
             Grade Glioma (HGG)&#xD;
&#xD;
          -  Has a performance status defined as follows: 1) Lansky Play Score ≥50 for participants&#xD;
             up to and including 16 years of age 2) Karnofsky performance status (KPS) ≥50 for&#xD;
             participants &gt;16 years of age 3) Neurologic deficits in participants with primary&#xD;
             central nervous system (CNS) tumors must have been stable for at least 7 days prior to&#xD;
             study enrollment&#xD;
&#xD;
          -  Demonstrate adequate organ function&#xD;
&#xD;
          -  No clinical evidence of nephrotic syndrome.&#xD;
&#xD;
          -  Has adequate blood pressure (BP) control with or without antihypertensive medications&#xD;
&#xD;
          -  Has adequate cardiac function&#xD;
&#xD;
          -  Has adequate neurologic function&#xD;
&#xD;
          -  Participant must have fully recovered to Common Terminology Criteria for Adverse&#xD;
             Events, Version 5.0 (CTCAE v5.0) Grade ≤1 (except for alopecia, ototoxicity, and Grade&#xD;
             ≤2 peripheral neuropathy) from the acute toxic effects of all prior anticancer therapy&#xD;
&#xD;
          -  Male participants must agree to use approved contraception during the treatment period&#xD;
             and for at least 7 days after the last dose of study intervention and refrain from&#xD;
             donating sperm during this period&#xD;
&#xD;
          -  Female participants are not pregnant and not breastfeeding, and are not a woman of&#xD;
             childbearing potential (WOCBP) or are a WOCBP who agrees to follow contraceptive&#xD;
             guidance during the treatment period and for at least 30 days after the last dose of&#xD;
             study intervention&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has had major surgery within 3 weeks prior to Cycle 1 Day 1 (C1D1)&#xD;
&#xD;
          -  Has gastrointestinal (GI) bleeding or active hemoptysis (bright red blood of at least&#xD;
             half teaspoon) within 21 days prior to enrollment&#xD;
&#xD;
          -  Has CNS tumors with a history of symptomatic tumor hemorrhage&#xD;
&#xD;
          -  Has evidence of new intracranial hemorrhage of more than punctate size on MRI&#xD;
             assessment obtained within 28 days prior to study enrollment&#xD;
&#xD;
          -  Has radiographic evidence of encasement or invasion of a major blood vessel or of&#xD;
             intratumoral cavitation&#xD;
&#xD;
          -  Has evidence of untreated CNS metastases (exception: participants with primary CNS&#xD;
             tumors and leptomeningeal disease.&#xD;
&#xD;
          -  Has GI malabsorption, GI anastomosis, or any other condition that in the opinion of&#xD;
             the investigator might affect the absorption of lenvatinib&#xD;
&#xD;
          -  Has preexisting ≥Grade 3 GI or non-GI fistula&#xD;
&#xD;
          -  Has any active infection requiring systemic therapy&#xD;
&#xD;
          -  Known to be Human immunodeficiency virus (HIV) positive&#xD;
&#xD;
          -  Known active viral hepatitis (B or C) as demonstrated by positive serology. Testing&#xD;
             for hepatitis B or hepatitis C is required at screening only when mandated by local&#xD;
             health authority&#xD;
&#xD;
          -  Is currently participating and receiving study therapy, or has participated in a study&#xD;
             of an investigational agent and received study therapy or used an investigational&#xD;
             device within 4 weeks of the date of allocation&#xD;
&#xD;
          -  Has a history or current evidence of any condition, therapy, or laboratory abnormality&#xD;
             that might confound the results of the study, interfere with the participant's&#xD;
             participation for the full duration of the study, or is not in the best interest of&#xD;
             the participant to participate, in the opinion of the treating investigator&#xD;
&#xD;
          -  Has known hypersensitivity to any component of the investigational product (lenvatinib&#xD;
             or ingredients)&#xD;
&#xD;
          -  Has known psychiatric or substance abuse disorders that would interfere with&#xD;
             cooperation with the requirements of the stud&#xD;
&#xD;
          -  Has clinically significant cardiovascular disease within 6 months from first dose of&#xD;
             study intervention, including New York Heart Association Class III or IV congestive&#xD;
             heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or&#xD;
             cardiac arrhythmia associated with hemodynamic instability&#xD;
&#xD;
          -  Has non-healing wound, tumor ulceration, unhealed or incompletely healed fracture, or&#xD;
             a compound (open) bone fracture at the time of enrollment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Merck Sharp &amp; Dohme LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Hospital of Colorado ( Site 0110)</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic ( Site 0119)</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Monroe Carell Jr. Children's Hospital at Vanderbilt ( Site 0102)</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mary Crowley Cancer Research Center ( Site 0107)</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Austral ( Site 0126)</name>
      <address>
        <city>Pilar</city>
        <state>Buenos Aires</state>
        <zip>B1629ODT</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Niños Ricardo Gutiérrez ( Site 0125)</name>
      <address>
        <city>Ciudad Autonoma de Buenos Aires</city>
        <state>Caba</state>
        <zip>C1425EFD</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sydney Children's Hospital ( Site 0801)</name>
      <address>
        <city>Randwick</city>
        <state>New South Wales</state>
        <zip>2031</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queensland Children s Hospital ( Site 0804)</name>
      <address>
        <city>Brisbane</city>
        <state>Queensland</state>
        <zip>4101</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Childrens Hospital Melbourne ( Site 0802)</name>
      <address>
        <city>Parkville</city>
        <state>Victoria</state>
        <zip>3052</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Perth Children s Hospital ( Site 0803)</name>
      <address>
        <city>Nedlands</city>
        <state>Western Australia</state>
        <zip>6009</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Gent ( Site 0250)</name>
      <address>
        <city>Gent</city>
        <state>Oost-Vlaanderen</state>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinicki bolnicki centar Rijeka ( Site 0726)</name>
      <address>
        <city>Rijeka</city>
        <state>Primorsko-goranska Zupanija</state>
        <zip>51000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinika za djecje bolesti Zagreb ( Site 0725)</name>
      <address>
        <city>Zagreb</city>
        <state>Zagrebacka Zupanija</state>
        <zip>10000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultni Nemocnice Brno Bohunice ( Site 0651)</name>
      <address>
        <city>Brno</city>
        <state>Brno-mesto</state>
        <zip>613 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultni nemocnice v Motole ( Site 0650)</name>
      <address>
        <city>Praha 5</city>
        <zip>150 06</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Leon-Berard ( Site 0326)</name>
      <address>
        <city>Lyon</city>
        <state>Auvergne</state>
        <zip>69008</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital La Timone ( Site 0328)</name>
      <address>
        <city>Marseille</city>
        <state>Bouches-du-Rhone</state>
        <zip>13005</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gustave Roussy ( Site 0327)</name>
      <address>
        <city>Villejuif</city>
        <state>Val-de-Marne</state>
        <zip>94800</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Curie ( Site 0325)</name>
      <address>
        <city>Paris</city>
        <zip>75005</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unidad Nacional de Oncologia Pediatrica ( Site 0176)</name>
      <address>
        <city>Guatemala</city>
        <zip>01011</zip>
        <country>Guatemala</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medi-K Cayala ( Site 0177)</name>
      <address>
        <city>Guatemala</city>
        <zip>01016</zip>
        <country>Guatemala</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi OktatoKorhaz ( Site 0678)</name>
      <address>
        <city>Miskolc</city>
        <state>Borsod-Abauj-Zemplen</state>
        <zip>3526</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Semmelweis University ( Site 0675)</name>
      <address>
        <city>Budapest</city>
        <zip>1094</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Debreceni Egyetem Klinikai Kozpont ( Site 0677)</name>
      <address>
        <city>Debrecen</city>
        <zip>4032</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chaim Sheba Medical Center ( Site 0500)</name>
      <address>
        <city>Ramat-Gan</city>
        <zip>5265601</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Ospedale Pediatrico Bambino Gesu ( Site 0410)</name>
      <address>
        <city>Rome</city>
        <state>Roma</state>
        <zip>00165</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O.Universitaria Meyer-Oncology &amp; Haematology Unit ( Site 0400)</name>
      <address>
        <city>Firenze</city>
        <state>Toscana</state>
        <zip>50139</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Giannina Gaslini ( Site 0411)</name>
      <address>
        <city>Genova</city>
        <zip>16147</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0401)</name>
      <address>
        <city>Milano</city>
        <zip>20133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Infantile Regina Margherita ( Site 0412)</name>
      <address>
        <city>Torino</city>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center ( Site 0876)</name>
      <address>
        <city>Songpagu</city>
        <state>Seoul</state>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital ( Site 0875)</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Starship Childrens Hospital ( Site 0826)</name>
      <address>
        <city>Auckland</city>
        <zip>1023</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Anglo Americana ( Site 0203)</name>
      <address>
        <city>San Isidro</city>
        <state>Lima</state>
        <zip>15073</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dmitry Rogachev National Research Center ( Site 0550)</name>
      <address>
        <city>Moscow</city>
        <state>Moskva</state>
        <zip>117198</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St.Petersburg State Medical Univ. n.a. acad. I.P.Pavlov ( Site 0554)</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Sankt-Peterburg</state>
        <zip>197022</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Center of specialized types medical care-Oncology ( Site 0553)</name>
      <address>
        <city>Saint-Petersburg</city>
        <state>Sankt-Peterburg</state>
        <zip>197758</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute for Oncology and Radiology of Serbia ( Site 0780)</name>
      <address>
        <city>Belgrade</city>
        <state>Beograd</state>
        <zip>11000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Univerzitetska decja klinika ( Site 0782)</name>
      <address>
        <city>Beograd</city>
        <zip>11000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wits Clinical Research ( Site 0579)</name>
      <address>
        <city>Soweto</city>
        <state>Gauteng</state>
        <zip>2013</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancercare Rondebosch Oncology ( Site 0575)</name>
      <address>
        <city>Cape Town</city>
        <state>Western Cape</state>
        <zip>7700</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tygerberg Hospital ( Site 0578)</name>
      <address>
        <city>Parow</city>
        <state>Western Cape</state>
        <zip>7505</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Sant Joan de Deu ( Site 0476)</name>
      <address>
        <city>Esplugues de Llobregat</city>
        <state>Barcelona</state>
        <zip>08950</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Nino Jesus ( Site 0477)</name>
      <address>
        <city>Madrid</city>
        <zip>28009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Skanes Universitetssjukhus Lund. ( Site 0525)</name>
      <address>
        <city>Lund</city>
        <state>Skane Lan</state>
        <zip>221 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hacettepe Universitesi Tip Fakultesi ( Site 0603)</name>
      <address>
        <city>Ankara</city>
        <zip>06100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istanbul Universitesi Onkoloji Enstitusu ( Site 0600)</name>
      <address>
        <city>Istanbul</city>
        <zip>34093</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ege Universitesi Tip Fakultesi ( Site 0601)</name>
      <address>
        <city>Izmir</city>
        <zip>35040</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dokuz Eylul Universitesi Arastirma Uygulama Hastanesi ( Site 0602)</name>
      <address>
        <city>Izmir</city>
        <zip>35330</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Australia</country>
    <country>Belgium</country>
    <country>Croatia</country>
    <country>Czechia</country>
    <country>France</country>
    <country>Guatemala</country>
    <country>Hungary</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Korea, Republic of</country>
    <country>New Zealand</country>
    <country>Peru</country>
    <country>Russian Federation</country>
    <country>Serbia</country>
    <country>South Africa</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>Turkey</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://merckoncologyclinicaltrials.com</url>
    <description>Merck Oncology Clinical Trials Information</description>
  </link>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>October 10, 2022</last_update_submitted>
  <last_update_submitted_qc>October 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 13, 2022</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>Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lenvatinib</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf</ipd_description>
    <ipd_url>http://engagezone.msd.com/ds_documentation.php</ipd_url>
  </patient_data>
  <pending_results>
    <submitted>September 7, 2023</submitted>
  </pending_results>
  <!-- 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/NCT04447755
org study id: 7902-013
secondary id: MK-7902-013
secondary id: 2019-004441-33
nct id: NCT04447755
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The main purpose of this study is to evaluate the antitumor activity and safety of Lenvatinib
      (MK-7902/E7080) in children, adolescents, and young adults with relapsed or refractory solid
      malignancies after administration. Participants will be enrolled into initial tumor-specific
      cohorts which will be expanded based on observed response.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
masking description: Open Label
measure: Objective Response Rate (ORR) At Week 16 per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) or Response Assessment in Neuro-Oncology (RANO) Criteria (for High Grade Glioma [HGG] only), by Investigator Assessment
time frame: Week 16 of treatment
description: ORR at Week 16 is defined as the percentage of participants with a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters [SOD] of target lesions, taking as reference the baseline SOD) as assessed by the investigator per RECIST 1.1 at 16 Weeks. For participants with HGG, response is assessed according to RANO criteria whereby overall response is based on both radiographic response (CR: disappearance of all target lesions, PR: sum of products of diameters [SPD] decreased by ≥ 50% from baseline value) and clinical performance status with steroid dose information.
measure: ORR per RECIST 1.1 or RANO Criteria (for HGG only), by Investigator Assessment
time frame: Up to approximately 43 months
description: ORR is defined as the percentage of participants with a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD) as assessed by the investigator per RECIST 1.1. For participants with HGG, response will be assessed according to RANO criteria whereby overall RANO response is based on both radiographic response (CR: disappearance of all target lesions, PR: SPD decreased by ≥ 50% from baseline value) and clinical performance status with steroid dose information.
measure: Progression Free Survival (PFS) per RECIST 1.1 or RANO (for HGG only), by Investigator Assessment
time frame: Up to approximately 43 months
description: PFS is defined as the time from the date of the first administration of study drug until the date of first documentation of progressive disease (PD) per RECIST 1.1 or RANO (for HGG) or death (whichever occurs first).
measure: Best Overall Response (BOR) per RECIST 1.1 or RANO (for HGG only), by Investigator Assessment
time frame: Up to approximately 43 months
description: BOR is defined as the participant's best confirmed response (CR or PR) over the treatment period as assessed by the investigator per RECIST 1.1 or RANO. As per RECIST 1.1, CR is defined as disappearance of all target lesions and PR is defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. For participants with HGG, response will be assessed according to RANO criteria whereby overall RANO response is based on both radiographic response (CR: disappearance of all target lesions, PR: SPD decreased by ≥ 50% from baseline value) and clinical performance status with steroid dose information.
measure: Duration of Response (DOR) per RECIST 1.1 or RANO (for HGG only), by Investigator Assessment
time frame: Up to approximately 43 months
description: DOR defined as the time from the date of the first documented CR or PR to the date first documentation of progressive disease or death (whichever occurs first). As per RECIST 1.1, CR is defined as disappearance of all target lesions and PR is defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. For participants with HGG, response will be assessed according to RANO criteria whereby overall RANO response is based on both radiographic response (CR: disappearance of all target lesions, PR: SPD decreased by ≥ 50% from baseline value) and clinical performance status with steroid dose information.
measure: Disease Control Rate (DCR) per RECIST 1.1 or RANO (for HGG only), by Investigator Assessment
time frame: Up to approximately 43 months
description: DCR is defined as a BOR of CR or PR, or stable disease (SD). To be assigned a BOR of SD, the time from the first administration of study drug until the date of documented SD should be ≥7 weeks. As per RECIST 1.1, CR is defined as disappearance of all target lesions, PR is defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, and SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. For participants with HGG, response is assessed according to RANO criteria whereby overall response is based on both radiographic response (CR: disappearance of all target lesions, PR: SPD decreased by ≥ 50% from baseline value and SD: SPD <50% decreased from baseline, but <25% increased from nadir) and clinical performance status with steroid dose information.
measure: Clinical Benefit Rate (CBR) per RECIST 1.1 or RANO (for HGG only), by Investigator Assessment
time frame: Up to approximately 43 months
description: CBR is defined as a BOR of CR or PR, or durable SD (Duration of SD should be ≥23 weeks since the first dose of the study treatment. As per RECIST 1.1, CR is defined as disappearance of all target lesions, PR is defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD and SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. For participants with HGG, response is assessed according to RANO criteria whereby overall response is based on both radiographic response (CR: disappearance of all target lesions, PR: SPD decreased by ≥ 50% from baseline value and SD: SPD <50% decreased from baseline, but <25% increased from nadir) and clinical performance status with steroid dose information.
measure: Number of Participants who Experience an Adverse Event (AE)
time frame: Up to approximately 43 months
description: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experience at least one AE will be reported.
measure: Number of Participants who Discontinue Study Treatment Due to an AE
time frame: Up to approximately 43 months
description: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinue study treatment due to an AE will be reported.
measure: Palatability Questionnaire Score For Lenvatinib Suspension Formulation
time frame: Cycle 1 Day 1 (cycle = 28 days)
description: A hedonic Visual Analog Scale (VAS) will be used to assess taste likability or "palatability" of a lenvatinib suspension formulated with water. Palatability will be rated based on 5 categories: taste, appearance, smell, mouth feel, and overall acceptability. Participants will score each category on a scale from 1-7 ranging from super bad (score = 1) to super good (score = 7). The VAS hedonic scale scores will be summarized using descriptive statistics for each cohort and the median score will be reported for each palatability category.
measure: Area Under the Concentration-Time Curve of lenvatinib From Time 0 to Infinity (AUC 0-inf)
time frame: At designated time points on Cycle 1 Day 1 (post-dose), Cycle 1 Day 15 (pre-dose and post-dose), and Cycle 2 Day 1 (pre-dose and post-dose). A cycle is 28 days.
description: Blood samples taken predose and at specified times postdose on Days 1-28 to determine the AUC 0-inf of Lenvatinib.
arm group label: Lenvatinib
arm group type: Experimental
description: Participants receive lenvatinib 14 mg/m^2 once daily (QD) orally until progressive disease or unacceptable toxicity (up to approximately 1 year).
intervention type: Drug
intervention name: Lenvatinib
description: Lenvatinib capsules administered orally at 14 mg/m^2 QD
arm group label: Lenvatinib
other name: MK-7902
other name: E7080
other name: LENVIMA
criteria: 
gender: All
minimum age: 2 Years
maximum age: 21 Years
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Merck Sharp & Dohme LLC
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Argentina
country: Australia
country: Belgium
country: Croatia
country: Czechia
country: France
country: Guatemala
country: Hungary
country: Israel
country: Italy
country: Korea, Republic of
country: New Zealand
country: Peru
country: Russian Federation
country: Serbia
country: South Africa
country: Spain
country: Sweden
country: Turkey
country: United States
url: http://merckoncologyclinicaltrials.com
description: Merck Oncology Clinical Trials Information
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Lenvatinib
sharing ipd: Yes
ipd description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
ipd url: http://engagezone.msd.com/ds_documentation.php
submitted: September 7, 2023