<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/NCT02250170</url>
  </required_header>
  <id_info>
    <org_study_id>317-KOA-1401i</org_study_id>
    <nct_id>NCT02250170</nct_id>
  </id_info>
  <brief_title>Safety and Biomarker of OPB-111077 in Subjects With Advanced Solid Tumor</brief_title>
  <official_title>A Phase 1, Open-label, Non-Randomized, Dose Escalation Trial to Evaluate Safety and Biomarker of OPB-111077 in Subjects With Advanced Solid Tumor</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Korea Otsuka Pharmaceutical Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Otsuka Pharmaceutical Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Korea Otsuka Pharmaceutical Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This open-label, non-randomized trial will comprise of 2 parts. A dose escalation part will&#xD;
      characterize the safety, biomarker and pharmacokinetics of OPB-111077 in advanced solid&#xD;
      tumor. Subsequently, an expansion part will further evaluate the biomarker, safety,&#xD;
      pharmacokinetics and antitumor activity of OPB-111077 in selected tumor types.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This trial is designed to determine the safety, tolerability, maximum tolerated dose and&#xD;
      recommended dose of OPB-111077 administered orally 4-days on and 3-days off (3 weeks/cycle)&#xD;
      to subjects with advanced solid tumor in the dose escalation part so that biomarkers,&#xD;
      efficacy, and others can be evaluated at the recommended dose in an expeditious manner in the&#xD;
      expansion part. The dose escalation part employs a 3+3 escalation design as a standard dose&#xD;
      escalation design for a small sample size.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 23, 2014</start_date>
  <completion_date type="Actual">March 8, 2019</completion_date>
  <primary_completion_date type="Actual">March 8, 2019</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>Adverse Events</measure>
    <time_frame>21 days</time_frame>
    <description>Number of participants with Adverse Events</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum tolerated dose</measure>
    <time_frame>21 days</time_frame>
    <description>The highest dose that does not lead to discontinuation of dose escalation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Biomarker of OPB-111077</measure>
    <time_frame>21 days</time_frame>
    <description>Change from baseline on predictable biomarker specified in the protocol</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tumor response measured by RECIST(Response Evaluation Criteria in Solid Tumor) 1.1 Assessment</measure>
    <time_frame>3~18 weeks depending on tumor response</time_frame>
    <description>Tumor response measured by RECIST(Response Evaluation Criteria in Solid Tumor) 1.1 Assessment will be conducted at Screening, end of Cycle 1, end of Cycle 2, end of every 2 cycles thereafter, at the final study visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK) properties of OPB-111077 and its metabolites.</measure>
    <time_frame>21 days</time_frame>
    <description>The following PK parameters (Cmax (maximum observed concentration), AUC(area uder the concentration time curve from zero), tmax (Time to maximum plasma concentration), etc.) will be determined using a non-compartmental methods.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">47</enrollment>
  <condition>Solid Tumor</condition>
  <arm_group>
    <arm_group_label>OPB-111077</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tablet, Oral, 300mg/500mg/700mg/900mg 4 days-on &amp; 3 days-off (21 days=1cycle)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>OPB-111077</intervention_name>
    <description>Tablet, Oral, 300mg/500mg/700mg/900mg 4 days-on &amp; 3 days-off (21 days=1cycle)</description>
    <arm_group_label>OPB-111077</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Pathologically and/or cytologically confirmed advanced solid tumor&#xD;
&#xD;
          2. Patients who were refractory to standard therapy or for which there are no standard&#xD;
             treatment options available&#xD;
&#xD;
          3. Age 20 to 80 years at the time of informed consent&#xD;
&#xD;
          4. Patients who, together with their partner, are willing and capable of using an&#xD;
             appropriate method of contraception throughout the trial period and until at least 12&#xD;
             weeks after final IMP administration&#xD;
&#xD;
          5. Patients informed of the diagnosis of advanced solid tumor who are fully informed&#xD;
             about the content of the study by the investigator or subinvestigator using the&#xD;
             specified written consent form and other written explanation, and give written consent&#xD;
             to participate in the study of their free will&#xD;
&#xD;
          6. Patients who are able to take oral medication&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with symptomatic brain metastases&#xD;
&#xD;
          2. Patients who have not recovered from any prior therapy related toxicity deemed to be&#xD;
             clinically significant at study entry, except for the test item defined in inclusion&#xD;
             criteria.&#xD;
&#xD;
          3. Patients with active infections needing whole body therapy&#xD;
&#xD;
          4. Patients with positive hepatitis B surface (HBs) antigen or positive hepatitis C virus&#xD;
             (HCV) antibody&#xD;
&#xD;
          5. Patients with positive human immunodeficiency virus (HIV) antibody&#xD;
&#xD;
          6. Patients with uncontrollable cardiac diseases&#xD;
&#xD;
          7. Patients with uncontrollable pain by analgesic drugs&#xD;
&#xD;
          8. Patients with a history of organ transplantation&#xD;
&#xD;
          9. Patients who have received another IMP&#xD;
&#xD;
         10. Patients who are pregnant, possibly pregnant, or lactating&#xD;
&#xD;
         11. Patients otherwise judged by the investigator or subinvestigator to be inappropriate&#xD;
             for inclusion in the trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Doyoun Oh, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jeehyun Kim, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Bundang Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sungbae Kim, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Asan Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>September 23, 2014</study_first_submitted>
  <study_first_submitted_qc>September 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <last_update_submitted>September 9, 2019</last_update_submitted>
  <last_update_submitted_qc>September 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 10, 2019</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>
  <!-- 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/NCT02250170
org study id: 317-KOA-1401i
nct id: NCT02250170
lead sponsor: 
collaborator: 
has dmc: No
This open-label, non-randomized trial will comprise of 2 parts. A dose escalation part will
      characterize the safety, biomarker and pharmacokinetics of OPB-111077 in advanced solid
      tumor. Subsequently, an expansion part will further evaluate the biomarker, safety,
      pharmacokinetics and antitumor activity of OPB-111077 in selected tumor types.
This trial is designed to determine the safety, tolerability, maximum tolerated dose and
      recommended dose of OPB-111077 administered orally 4-days on and 3-days off (3 weeks/cycle)
      to subjects with advanced solid tumor in the dose escalation part so that biomarkers,
      efficacy, and others can be evaluated at the recommended dose in an expeditious manner in the
      expansion part. The dose escalation part employs a 3+3 escalation design as a standard dose
      escalation design for a small sample size.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Adverse Events
time frame: 21 days
description: Number of participants with Adverse Events
measure: Maximum tolerated dose
time frame: 21 days
description: The highest dose that does not lead to discontinuation of dose escalation
measure: Biomarker of OPB-111077
time frame: 21 days
description: Change from baseline on predictable biomarker specified in the protocol
measure: Tumor response measured by RECIST(Response Evaluation Criteria in Solid Tumor) 1.1 Assessment
time frame: 3~18 weeks depending on tumor response
description: Tumor response measured by RECIST(Response Evaluation Criteria in Solid Tumor) 1.1 Assessment will be conducted at Screening, end of Cycle 1, end of Cycle 2, end of every 2 cycles thereafter, at the final study visit.
measure: Pharmacokinetics (PK) properties of OPB-111077 and its metabolites.
time frame: 21 days
description: The following PK parameters (Cmax (maximum observed concentration), AUC(area uder the concentration time curve from zero), tmax (Time to maximum plasma concentration), etc.) will be determined using a non-compartmental methods.
arm group label: OPB-111077
arm group type: Experimental
description: Tablet, Oral, 300mg/500mg/700mg/900mg 4 days-on & 3 days-off (21 days=1cycle)
intervention type: Drug
intervention name: OPB-111077
description: Tablet, Oral, 300mg/500mg/700mg/900mg 4 days-on & 3 days-off (21 days=1cycle)
arm group label: OPB-111077
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Doyoun Oh, MD
role: Principal Investigator
affiliation: Seoul National University Hospital
last name: Jeehyun Kim, MD
role: Principal Investigator
affiliation: Seoul National University Bundang Hospital
last name: Sungbae Kim, MD
role: Principal Investigator
affiliation: Asan Medical Center
facility: 
facility: 
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Neoplasms