<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/NCT02210663</url>
  </required_header>
  <id_info>
    <org_study_id>M14-489</org_study_id>
    <nct_id>NCT02210663</nct_id>
  </id_info>
  <brief_title>A Phase 1 Study of Single Agent Veliparib in Japanese Subjects With Advanced Solid Tumors</brief_title>
  <official_title>A Phase 1 Study of Single Agent Veliparib in Japanese Subjects With Advanced Solid Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AbbVie</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AbbVie</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase 1 study to evaluate the tolerability, safety, pharmacokinetics and&#xD;
      preliminary efficacy of single agent Veliparib in Japanese subjects with advanced solid&#xD;
      tumors.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</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>Dose-limiting toxicities of veliparib</measure>
    <time_frame>During the first cycle (28 days) of veliparib administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in participant physical exam measurements</measure>
    <time_frame>Approximately 1 year</time_frame>
    <description>Blood pressure, pulse and body temperature</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in participant clinical lab results</measure>
    <time_frame>Approximately 1 year</time_frame>
    <description>Hematology, Chemistry and Urinalysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events</measure>
    <time_frame>Approximately 1 year</time_frame>
    <description>Collect all adverse events at each visit and assess according to National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preliminary tumor response</measure>
    <time_frame>Participants will be followed for the duration of an expected average of 8 months.</time_frame>
    <description>According to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum observed plasma concentration (Cmax)</measure>
    <time_frame>For 24 hours following veliparib dosing.</time_frame>
    <description>Maximum observed concentration, occurring at Tmax</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The time to Cmax (peak time, Tmax)</measure>
    <time_frame>For 24 hours following veliparib dosing.</time_frame>
    <description>The time at which maximum plasma concentration (Cmax) is observed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The area under the plasma concentration-time curve (AUC)</measure>
    <time_frame>For 24 hours following veliparib dosing.</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Advanced Solid Tumors</condition>
  <arm_group>
    <arm_group_label>veliparib (ABT-888)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>veliparib (ABT-888)</intervention_name>
    <description>Subjects will be given veliparib twice daily on Days 1-28 every 28 days orally.</description>
    <arm_group_label>veliparib (ABT-888)</arm_group_label>
    <other_name>veliparib</other_name>
    <other_name>ABT-888</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically or cytologically confirmed malignant solid tumor, and any of the&#xD;
             following: * Subjects with recurrent high grade serous ovarian cancer who completed or&#xD;
             discontinued platinum based therapy; * Subjects with BRCA-mutated breast cancer who&#xD;
             have received prior chemotherapy with anthracycline and/or taxanes; * Subjects with&#xD;
             deleterious mutations of BRCA with advanced solid tumors who have received available&#xD;
             standard therapies.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.&#xD;
&#xD;
          -  Life expectancy of greater than 12 weeks.&#xD;
&#xD;
          -  Adequate organ and marrow function· Measurable or non-measurable disease.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Major surgery and/or radiation within (&lt;) 4 weeks prior to study enrollment.&#xD;
&#xD;
          -  Chemotherapy or hormone therapy within (&lt;) 4 weeks prior to study enrollment except&#xD;
             for mitomycin C and nitrosoureas, in which case it is 6 weeks.&#xD;
&#xD;
          -  Any investigational agents within (&lt;) 4 weeks prior to study enrollment.&#xD;
&#xD;
          -  Any anti-cancer Chinese medicine/herbal remedies within 14 days prior to study&#xD;
             enrollment.&#xD;
&#xD;
          -  Toxicities (with the exception of alopecia) from prior major surgery, radiation, or&#xD;
             systemic chemotherapy have not recovered to less than grade 2.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hideyuki Hashiba, BS</last_name>
    <role>Study Director</role>
    <affiliation>AbbVie GK.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 128056</name>
      <address>
        <city>Hidaka-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 129976</name>
      <address>
        <city>Hyogo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 128057</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <results_reference>
    <citation>Nishikawa T, Matsumoto K, Tamura K, Yoshida H, Imai Y, Miyasaka A, Onoe T, Yamaguchi S, Shimizu C, Yonemori K, Shimoi T, Yunokawa M, Xiong H, Nuthalapati S, Hashiba H, Kiriyama T, Leahy T, Komarnitsky P, Fujiwara K. Phase 1 dose-escalation study of single-agent veliparib in Japanese patients with advanced solid tumors. Cancer Sci. 2017 Sep;108(9):1834-1842. doi: 10.1111/cas.13307. Epub 2017 Aug 5.</citation>
    <PMID>28665051</PMID>
  </results_reference>
  <verification_date>July 2016</verification_date>
  <study_first_submitted>July 25, 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>May 2, 2018</last_update_submitted>
  <last_update_submitted_qc>May 2, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Breast cancer</keyword>
  <keyword>PARP</keyword>
  <keyword>Primary peritoneal cancer</keyword>
  <keyword>Fallopian tube</keyword>
  <keyword>Ovarian cancer</keyword>
  <keyword>veliparib</keyword>
  <keyword>ABT-888</keyword>
  <keyword>BRCA</keyword>
  <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>Veliparib</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/NCT02210663
org study id: M14-489
nct id: NCT02210663
lead sponsor: 
has dmc: Yes
This is a Phase 1 study to evaluate the tolerability, safety, pharmacokinetics and
      preliminary efficacy of single agent Veliparib in Japanese subjects with advanced solid
      tumors.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Dose-limiting toxicities of veliparib
time frame: During the first cycle (28 days) of veliparib administration
measure: Change in participant physical exam measurements
time frame: Approximately 1 year
description: Blood pressure, pulse and body temperature
measure: Change in participant clinical lab results
time frame: Approximately 1 year
description: Hematology, Chemistry and Urinalysis
measure: Number of participants with adverse events
time frame: Approximately 1 year
description: Collect all adverse events at each visit and assess according to National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03
measure: Preliminary tumor response
time frame: Participants will be followed for the duration of an expected average of 8 months.
description: According to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1
measure: Maximum observed plasma concentration (Cmax)
time frame: For 24 hours following veliparib dosing.
description: Maximum observed concentration, occurring at Tmax
measure: The time to Cmax (peak time, Tmax)
time frame: For 24 hours following veliparib dosing.
description: The time at which maximum plasma concentration (Cmax) is observed.
measure: The area under the plasma concentration-time curve (AUC)
time frame: For 24 hours following veliparib dosing.
arm group label: veliparib (ABT-888)
arm group type: Experimental
intervention type: Drug
intervention name: veliparib (ABT-888)
description: Subjects will be given veliparib twice daily on Days 1-28 every 28 days orally.
arm group label: veliparib (ABT-888)
other name: veliparib
other name: ABT-888
criteria: 
gender: All
minimum age: 20 Years
maximum age: 99 Years
healthy volunteers: No
last name: Hideyuki Hashiba, BS
role: Study Director
affiliation: AbbVie GK.
facility: 
facility: 
facility: 
country: Japan
citation: Nishikawa T, Matsumoto K, Tamura K, Yoshida H, Imai Y, Miyasaka A, Onoe T, Yamaguchi S, Shimizu C, Yonemori K, Shimoi T, Yunokawa M, Xiong H, Nuthalapati S, Hashiba H, Kiriyama T, Leahy T, Komarnitsky P, Fujiwara K. Phase 1 dose-escalation study of single-agent veliparib in Japanese patients with advanced solid tumors. Cancer Sci. 2017 Sep;108(9):1834-1842. doi: 10.1111/cas.13307. Epub 2017 Aug 5.
PMID: 28665051
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Veliparib