<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/NCT03838926</url>
  </required_header>
  <id_info>
    <org_study_id>VP-VTR-297-1101</org_study_id>
    <nct_id>NCT03838926</nct_id>
  </id_info>
  <brief_title>Tolerability Study of Trichostatin A In Subjects With Relapsed or Refractory Hematologic Malignancies</brief_title>
  <official_title>Tolerability Study of Trichostatin A In Subjects With Relapsed or Refractory Hematologic Malignancies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanda Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vanda Pharmaceuticals</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to investigate the safety and tolerability of trichostatin A in&#xD;
      individuals with relapsed or refractory hematologic malignancies.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 27, 2018</start_date>
  <completion_date type="Anticipated">September 2020</completion_date>
  <primary_completion_date type="Anticipated">August 2020</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>Safety and tolerability of trichostatin A measured by spontaneous reporting of adverse events (AEs)</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Measured by spontaneous reporting of adverse events (AEs)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dose-limiting toxicities (DLTs) and maximum tolerated dose (MTD) of trichostatin A</measure>
    <time_frame>Up to 24 months</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">42</enrollment>
  <condition>Relapsed or Refractory Hematologic Malignancies</condition>
  <arm_group>
    <arm_group_label>Trichostatin A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Trichostatin A</intervention_name>
    <description>Intravenous Infusion</description>
    <arm_group_label>Trichostatin A</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is ≥ 18 years at the time of signing informed consent;&#xD;
&#xD;
          -  Confirmed malignant hematologic disease or lymphoid malignancy that has relapsed or is&#xD;
             refractory to standard therapy and has exhausted all available therapies;&#xD;
&#xD;
          -  Presence of measurable or evaluable disease;&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2;&#xD;
&#xD;
          -  Contraceptives or other approved avoidance of pregnancy measures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allogeneic stem cell transplant recipient presenting with graft versus host disease&#xD;
             (GVHD) either active or requiring immunosuppression;&#xD;
&#xD;
          -  Concomitantly taking anti-cancer therapy (bisphosphonates are permitted);&#xD;
&#xD;
          -  Undergone major surgery ≤ 2 weeks prior to starting study drug;&#xD;
&#xD;
          -  Evidence of mucosal or internal bleeding;&#xD;
&#xD;
          -  Impaired cardiac function or conduction defect;&#xD;
&#xD;
          -  Concurrent severe and/or uncontrolled medical conditions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Vanda Pharmaceuticals</last_name>
    <phone>202-734-3400</phone>
    <email>clinicaltrials@vandapharma.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Vanda Investigational Site</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20007</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vanda Pharmaceuticals</last_name>
      <phone>202-734-3400</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Vanda Investigational Site</name>
      <address>
        <city>Lafayette</city>
        <state>Indiana</state>
        <zip>47905</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vanda Pharmaceuticals</last_name>
      <phone>202-734-3400</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Vanda Investigational Site</name>
      <address>
        <city>Fairway</city>
        <state>Kansas</state>
        <zip>66205</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vanda Pharmaceuticals</last_name>
      <phone>202-734-3400</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Vanda Investigational Site</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vanda Pharmaceuticals</last_name>
      <phone>202-734-3400</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Vanda Investigational Site</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vanda Pharmaceuticals</last_name>
      <phone>202-734-3400</phone>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 11, 2019</study_first_submitted>
  <study_first_submitted_qc>February 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>February 11, 2019</last_update_submitted>
  <last_update_submitted_qc>February 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hematologic</keyword>
  <keyword>Malignancies</keyword>
  <keyword>Cancer</keyword>
  <keyword>Blood</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Hematologic Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Trichostatin A</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/NCT03838926
org study id: VP-VTR-297-1101
nct id: NCT03838926
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
The aim of this study is to investigate the safety and tolerability of trichostatin A in
      individuals with relapsed or refractory hematologic malignancies.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety and tolerability of trichostatin A measured by spontaneous reporting of adverse events (AEs)
time frame: Up to 24 months
description: Measured by spontaneous reporting of adverse events (AEs)
measure: Dose-limiting toxicities (DLTs) and maximum tolerated dose (MTD) of trichostatin A
time frame: Up to 24 months
arm group label: Trichostatin A
arm group type: Experimental
intervention type: Drug
intervention name: Trichostatin A
description: Intravenous Infusion
arm group label: Trichostatin A
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Vanda Pharmaceuticals
phone: 202-734-3400
email: clinicaltrials@vandapharma.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Hematologic Neoplasms
mesh term: Trichostatin A