<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/NCT01722825</url>
  </required_header>
  <id_info>
    <org_study_id>14854</org_study_id>
    <secondary_id>H9H-JE-JBAN</secondary_id>
    <nct_id>NCT01722825</nct_id>
  </id_info>
  <brief_title>Study of LY2157299 in Japanese Participants With Cancer</brief_title>
  <official_title>Phase 1 Dose-Escalation Study of LY2157299 Monotherapy in Patients With Solid Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eli Lilly and Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eli Lilly and Company</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purpose of this study is to evaluate the safety and side effects of LY2157299 in&#xD;
      Japanese participants with advanced cancer or cancer that has spread to other parts of the&#xD;
      body.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants with Dose-Limiting Toxicities</measure>
    <time_frame>Day 1 through Day 28 of Cycle 1</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics: Maximum Concentration (Cmax) of LY2157299</measure>
    <time_frame>Days 1, 3, 6 and 14 of Cycle 1 and Days 1 and 14 of Cycle 2</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of LY2157299</measure>
    <time_frame>Predose up to 6 hours postdose on Days 1 and 14 of Cycles 1 and 2</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with a Tumor Response</measure>
    <time_frame>Baseline to study completion estimated at 16 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">12</enrollment>
  <condition>Neoplasms</condition>
  <condition>Neoplasm Metastasis</condition>
  <arm_group>
    <arm_group_label>LY2157299</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>80 up to 150 milligrams of LY2157299 administered orally, twice daily for 14 days, followed by 14 days with no study drug (2 weeks on/2 weeks off schedule) for at least two 28 day cycles. Participants receiving clinical benefit may continue receiving treatment until discontinuation criterion is met.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LY2157299</intervention_name>
    <description>Administered orally.</description>
    <arm_group_label>LY2157299</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have histological or cytological evidence of a diagnosis of cancer that is advanced&#xD;
             and/or metastatic. The participants must be, in the judgment of the investigator, an&#xD;
             appropriate candidate for experimental therapy after available standard therapies have&#xD;
             failed to provide clinical benefit for their disease.&#xD;
&#xD;
          -  Have the presence of measurable or nonmeasurable disease as defined by the Response&#xD;
             Evaluation Criteria in Solid Tumors.&#xD;
&#xD;
          -  Have a performance status of higher than or equal to 1 on the Eastern Cooperative&#xD;
             Oncology Group scale.&#xD;
&#xD;
          -  Have adequate hematologic, hepatic and renal function.&#xD;
&#xD;
          -  Have discontinued treatments for cancer excluding palliative treatments and recovered&#xD;
             from the acute effects of therapy.&#xD;
&#xD;
          -  Have discontinued treatment at least 28 days prior to the enrollment for an&#xD;
             experimental agent that has not received regulatory approval for any indication.&#xD;
&#xD;
          -  Are reliable and willing to make themselves available for the duration of the study&#xD;
             and are willing to follow study procedures.&#xD;
&#xD;
          -  Able to swallow tablets.&#xD;
&#xD;
          -  Have an estimated life expectancy, in the judgment of the investigator, that will&#xD;
             permit the participant to complete greater than or equal to 2 cycles of treatment.&#xD;
&#xD;
          -  Males and females with reproductive potential: Must agree to use medically approved&#xD;
             contraceptive precautions during the study and for 4 months following the last dose of&#xD;
             study drug.&#xD;
&#xD;
          -  Females with child bearing potential: Have had a negative urine/serum pregnancy test&#xD;
             greater than or equal to 7 days before the first dose of study drug and must also not&#xD;
             be breastfeeding. If female who stops breastfeeding enters the study, the female must&#xD;
             stop breastfeeding from the day of the first study drug administration until at least&#xD;
             30 days after the last administration.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have moderate or severe cardiac disease:&#xD;
&#xD;
               -  Have the presence of cardiac disease, including a myocardial infarction within 6&#xD;
                  months prior to study entry, angina pectoris, New York Heart Association Class&#xD;
                  III/IV congestive heart failure, or uncontrolled severe hypertension.&#xD;
&#xD;
               -  Have documented major electrocardiogram abnormalities at the investigator's&#xD;
                  discretion.&#xD;
&#xD;
               -  Have major abnormalities documented by echocardiography with Doppler. Clinically&#xD;
                  non-significant abnormalities are excluded from this criterion.&#xD;
&#xD;
               -  Have persistently elevated brain natriuretic peptide or elevated Troponin I at&#xD;
                  screening local laboratory tests.&#xD;
&#xD;
               -  Have predisposing conditions that are consistent with development of aneurysms of&#xD;
                  the ascending aorta or aortic stress.&#xD;
&#xD;
               -  Have a history of cardiac or aortic surgery.&#xD;
&#xD;
          -  Have current hematological malignancies.&#xD;
&#xD;
          -  Have central nervous system metastases.&#xD;
&#xD;
          -  Have serious preexisting medical conditions as follows;&#xD;
&#xD;
               -  Presence or history of interstitial pneumonitis&#xD;
&#xD;
               -  Uncontrollable severe diabetes&#xD;
&#xD;
               -  Presence of serious active infection or uncontrollable chronic infection&#xD;
&#xD;
               -  Presence of liver cirrhosis with Child-Pugh Stage of B or C&#xD;
&#xD;
               -  Other serious conditions judged by the investigator&#xD;
&#xD;
          -  Have known positive test results in human immunodeficiency virus (HIV), hepatitis B&#xD;
             surface antigen, or hepatitis C antibodies (HC Ab). Testing is not required unless&#xD;
             circumstances warrant confirmation.&#xD;
&#xD;
          -  In the opinion of the investigator or sponsor, are unsuitable for inclusion in the&#xD;
             study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Call 1-877-CTLILLY (1-877-285-4559 ) or 1-317-615-4559 Mon - Fri 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST)</last_name>
    <role>Study Director</role>
    <affiliation>Eli Lilly and Company</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559 ) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Tokyo</city>
        <zip>104-0045</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>June 2014</verification_date>
  <study_first_submitted>November 5, 2012</study_first_submitted>
  <study_first_submitted_qc>November 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 7, 2012</study_first_posted>
  <last_update_submitted>June 30, 2014</last_update_submitted>
  <last_update_submitted_qc>June 30, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 1, 2014</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>
    <mesh_term>Neoplasm Metastasis</mesh_term>
  </condition_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/NCT01722825
org study id: 14854
secondary id: H9H-JE-JBAN
nct id: NCT01722825
lead sponsor: 
has dmc: No
The main purpose of this study is to evaluate the safety and side effects of LY2157299 in
      Japanese participants with advanced cancer or cancer that has spread to other parts of the
      body.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants with Dose-Limiting Toxicities
time frame: Day 1 through Day 28 of Cycle 1
measure: Pharmacokinetics: Maximum Concentration (Cmax) of LY2157299
time frame: Days 1, 3, 6 and 14 of Cycle 1 and Days 1 and 14 of Cycle 2
measure: Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of LY2157299
time frame: Predose up to 6 hours postdose on Days 1 and 14 of Cycles 1 and 2
measure: Number of Participants with a Tumor Response
time frame: Baseline to study completion estimated at 16 weeks
arm group label: LY2157299
arm group type: Experimental
description: 80 up to 150 milligrams of LY2157299 administered orally, twice daily for 14 days, followed by 14 days with no study drug (2 weeks on/2 weeks off schedule) for at least two 28 day cycles. Participants receiving clinical benefit may continue receiving treatment until discontinuation criterion is met.
intervention type: Drug
intervention name: LY2157299
description: Administered orally.
arm group label: LY2157299
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Call 1-877-CTLILLY (1-877-285-4559 ) or 1-317-615-4559 Mon - Fri 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST)
role: Study Director
affiliation: Eli Lilly and Company
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Neoplasm Metastasis