<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/NCT02236195</url>
  </required_header>
  <id_info>
    <org_study_id>0103-018</org_study_id>
    <nct_id>NCT02236195</nct_id>
  </id_info>
  <brief_title>Study of Mocetinostat in Patients With Urothelial Carcinoma Having Inactivating Alterations of Specific Genes</brief_title>
  <official_title>An Open-Label, Single-Arm, Phase 2 Study of Mocetinostat in Selected Patients With Inactivating Alterations of Acetyltransferase Genes in Previously Treated Locally Advanced or Metastatic Urothelial Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mirati Therapeutics Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mirati Therapeutics Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Mocetinostat is an orally administered histone deacetylase (HDAC) inhibitor. This study is a&#xD;
      Phase 2 trial evaluating the efficacy of mocetinostat in patients that have advanced&#xD;
      urothelial carcinoma that has specific changes in tumor genes. Patients must have previously&#xD;
      received treatment with chemotherapy that included a &quot;platinum-containing agent&quot; such as&#xD;
      cisplatin. The study will enroll in stages, with 15 patients in the first stage. More&#xD;
      patients will be added to the study if enough patients having beneficial responses are&#xD;
      observed. Mocetinostat will be administered using oral capsules three times each week (eg,&#xD;
      Monday, Wednesday and Friday). The study is designed to evaluate whether the number of&#xD;
      patients responding to treatment is substantially higher than would be expected with other&#xD;
      available treatments.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To be eligible for this study, patient tumor testing must demonstrate a genetic alteration&#xD;
      resulting in the loss of function of the Histone Acetyltransferase (HAT) family genes, CREBBP&#xD;
      and/or EP300, including gene deletions or selected inactivating mutations. If testing has not&#xD;
      already been performed, the study will provide for the testing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">April 2016</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>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients experiencing tumor size reduction</measure>
    <time_frame>Up to 4 months</time_frame>
    <description>Tumors will be measured using radiographic scans. Tumor size reduction and overall disease response will be categorized according to the Response Evaluation Criteria In Solid Tumors (RECIST 1.1).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients experiencing adverse events</measure>
    <time_frame>Up to 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak blood plasma concentration of mocetinostat</measure>
    <time_frame>Up to 48 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Urothelial Carcinoma</condition>
  <arm_group>
    <arm_group_label>Mocetinostat</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mocetinostat (MGCD0103) oral capsules three times weekly, 70 mg doses in first month, with increase to 90 mg doses if tolerated</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mocetinostat</intervention_name>
    <arm_group_label>Mocetinostat</arm_group_label>
    <other_name>MGCD0103</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of urothelial carcinoma&#xD;
&#xD;
          -  Metastatic or locally advanced disease&#xD;
&#xD;
          -  Prior chemotherapy that included a platinum agent&#xD;
&#xD;
          -  Test results showing genetic change in tumor gene for CREBBP and/or EP300&#xD;
&#xD;
          -  At least one tumor that can be measured&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Uncontrolled tumor in the brain&#xD;
&#xD;
          -  Impaired heart function&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Alabama</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City of Hope National Medical Center</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Cancer Specialists</name>
      <address>
        <city>Fort Myers</city>
        <state>Florida</state>
        <zip>33905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins University</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dana-Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Rochester</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14627</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of North Carolina</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic Foundation</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio State University</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Huntsman Cancer Institute</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>September 4, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <disposition_first_submitted>August 29, 2017</disposition_first_submitted>
  <disposition_first_submitted_qc>August 30, 2017</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">September 1, 2017</disposition_first_posted>
  <last_update_submitted>August 30, 2017</last_update_submitted>
  <last_update_submitted_qc>August 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Urothelial</keyword>
  <keyword>Bladder</keyword>
  <keyword>HDAC</keyword>
  <keyword>MGCD0103</keyword>
  <keyword>Mocetinostat</keyword>
  <keyword>CREBBP</keyword>
  <keyword>EP300</keyword>
  <keyword>Mirati</keyword>
  <keyword>MethylGene</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Transitional Cell</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mocetinostat</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT02236195
org study id: 0103-018
nct id: NCT02236195
lead sponsor: 
has dmc: No
Mocetinostat is an orally administered histone deacetylase (HDAC) inhibitor. This study is a
      Phase 2 trial evaluating the efficacy of mocetinostat in patients that have advanced
      urothelial carcinoma that has specific changes in tumor genes. Patients must have previously
      received treatment with chemotherapy that included a "platinum-containing agent" such as
      cisplatin. The study will enroll in stages, with 15 patients in the first stage. More
      patients will be added to the study if enough patients having beneficial responses are
      observed. Mocetinostat will be administered using oral capsules three times each week (eg,
      Monday, Wednesday and Friday). The study is designed to evaluate whether the number of
      patients responding to treatment is substantially higher than would be expected with other
      available treatments.
To be eligible for this study, patient tumor testing must demonstrate a genetic alteration
      resulting in the loss of function of the Histone Acetyltransferase (HAT) family genes, CREBBP
      and/or EP300, including gene deletions or selected inactivating mutations. If testing has not
      already been performed, the study will provide for the testing.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of patients experiencing tumor size reduction
time frame: Up to 4 months
description: Tumors will be measured using radiographic scans. Tumor size reduction and overall disease response will be categorized according to the Response Evaluation Criteria In Solid Tumors (RECIST 1.1).
measure: Number of patients experiencing adverse events
time frame: Up to 12 months
measure: Peak blood plasma concentration of mocetinostat
time frame: Up to 48 hours
arm group label: Mocetinostat
arm group type: Experimental
description: Mocetinostat (MGCD0103) oral capsules three times weekly, 70 mg doses in first month, with increase to 90 mg doses if tolerated
intervention type: Drug
intervention name: Mocetinostat
arm group label: Mocetinostat
other name: MGCD0103
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
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country: United States
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Transitional Cell
mesh term: Mocetinostat