<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/NCT02213861</url>
  </required_header>
  <id_info>
    <org_study_id>SHP-141-003</org_study_id>
    <nct_id>NCT02213861</nct_id>
  </id_info>
  <brief_title>Efficacy, Safety and Tolerability Study of SHAPE in IA, IB or IIA Cutaneous T-cell Lymphoma</brief_title>
  <official_title>A Randomized Phase 2 Study to Evaluate Three Treatment Regimens of SHAPE, a Histone Deacetylase Inhibitor, in Patients With Stage IA, IB or IIA Cutaneous T-Cell Lymphoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>TetraLogic Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>TetraLogic Pharmaceuticals</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the efficacy, safety and tolerability of SHAPE&#xD;
      administered topically to skin lesions in patients with early-stage cutaneous T-cell lymphoma&#xD;
      (CTCL).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase 2, multicenter, open-label, randomized study to evaluate the efficacy and&#xD;
      safety of SHAPE Gelled Solution applied topically daily or twice daily for 26 consecutive&#xD;
      weeks to specified skin lesions in patients with Stage IA, IB or IIA CTCL. Patients&#xD;
      responding to treatment will be allowed to continue on study for a maximum of 52 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>November 2014</start_date>
  <completion_date type="Anticipated">October 2016</completion_date>
  <primary_completion_date type="Anticipated">October 2016</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Lesion severity using CAILS (Composite Assessment of Index Lesion Severity)</measure>
    <time_frame>Every 4 weeks for 26 weeks and every 4 weeks thereafter for patients who continue on study (up to 52 weeks).</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>modified Severity Weighted Assessment Tool (mSWAT)</measure>
    <time_frame>Every 4 weeks for 26 weeks and every 4 weeks therafter for patients who continue on study (up to 52 weeks).</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient assessment of pruritis using a Visual Analog Scale (VAS)</measure>
    <time_frame>Every 4 weeks for 26 weeks and every 4 weeks thereafter for patients who continue on study (up to 52 weeks).</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Skindex-29 Quality of Life Tool</measure>
    <time_frame>Every 4 weeks for 26 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>modified Composite Assessment of Index Lesion Severity (CAILS)</measure>
    <time_frame>Every 4 weeks for 26 weeks and every 4 weeks therafter for patients who continue on study (up to 52 weeks).</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Cutaneous T-Cell Lymphoma (CTCL)</condition>
  <arm_group>
    <arm_group_label>1.0% SHAPE Gelled Solution once daily</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>0.5% SHAPE Gelled Solution twice daily</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>1.0% SHAPE Gelled Solution twice daily</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SHAPE</intervention_name>
    <description>topical gel</description>
    <arm_group_label>0.5% SHAPE Gelled Solution twice daily</arm_group_label>
    <arm_group_label>1.0% SHAPE Gelled Solution once daily</arm_group_label>
    <arm_group_label>1.0% SHAPE Gelled Solution twice daily</arm_group_label>
    <other_name>SHP-141</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histological confirmation of CTCL; a documented verifiable biopsy report is required&#xD;
&#xD;
          -  Documented clinical stage IA, IB or IIA CTCL&#xD;
&#xD;
          -  Skin lesion involvement of at least 2% of BSA accessible for topical application of&#xD;
             study drug&#xD;
&#xD;
          -  ECOG performance status of 0-2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  CTCL with histologic evidence of folliculotropic variant or large cell transformed&#xD;
             CTCL&#xD;
&#xD;
          -  Palpable lymph node ≥1.5 cm in diameter (unless the lymph node has been biopsied and&#xD;
             designated as Stage IA-IIA disease)&#xD;
&#xD;
          -  Co-existent second malignancy or history of prior solid organ malignancy within&#xD;
             previous 5 years (excluding basal or squamous cell carcinoma, in situ carcinoma of the&#xD;
             cervix (CIN3), papillary or follicular thyroid cancer or prostate cancer that has been&#xD;
             treated curatively&#xD;
&#xD;
          -  Any prior history of hematologic malignancy (other than CTCL) within past 5 years&#xD;
&#xD;
          -  CTCL disease that is known to be refractory to systemic histone deacetylase inhibitors&#xD;
&#xD;
          -  Prior or concurrent central nervous system (CNS) metastases&#xD;
&#xD;
          -  History of or current major gastrointestinal, pulmonary, cardiovascular, genitourinary&#xD;
             or hematologic disease, CNS disorders, infectious disease or coagulation disorders as&#xD;
             determined by the Investigator&#xD;
&#xD;
          -  Evidence of active Hepatitis B or C or HIV&#xD;
&#xD;
          -  Circulating atypical cells of clinical significance&#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>Stanford Cancer Center</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern Medical Group</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</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>The Ohio State University Wexner Medical Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Texas MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>August 6, 2014</study_first_submitted>
  <study_first_submitted_qc>August 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 12, 2014</study_first_posted>
  <last_update_submitted>October 18, 2016</last_update_submitted>
  <last_update_submitted_qc>October 18, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 20, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CTCL</keyword>
  <keyword>Cutaneous T-Cell Lymphoma</keyword>
  <keyword>Early-stage</keyword>
  <keyword>SHAPE</keyword>
  <keyword>SHP-141</keyword>
  <keyword>topical</keyword>
  <keyword>Histone deacetylase inhibitor</keyword>
  <keyword>CAILS</keyword>
  <keyword>mSWAT</keyword>
  <keyword>mycosis fungoides</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Lymphoma, T-Cell</mesh_term>
    <mesh_term>Lymphoma, T-Cell, Peripheral</mesh_term>
    <mesh_term>Lymphoma, T-Cell, Cutaneous</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/NCT02213861
org study id: SHP-141-003
nct id: NCT02213861
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the efficacy, safety and tolerability of SHAPE
      administered topically to skin lesions in patients with early-stage cutaneous T-cell lymphoma
      (CTCL).
This is a Phase 2, multicenter, open-label, randomized study to evaluate the efficacy and
      safety of SHAPE Gelled Solution applied topically daily or twice daily for 26 consecutive
      weeks to specified skin lesions in patients with Stage IA, IB or IIA CTCL. Patients
      responding to treatment will be allowed to continue on study for a maximum of 52 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Lesion severity using CAILS (Composite Assessment of Index Lesion Severity)
time frame: Every 4 weeks for 26 weeks and every 4 weeks thereafter for patients who continue on study (up to 52 weeks).
measure: modified Severity Weighted Assessment Tool (mSWAT)
time frame: Every 4 weeks for 26 weeks and every 4 weeks therafter for patients who continue on study (up to 52 weeks).
measure: Patient assessment of pruritis using a Visual Analog Scale (VAS)
time frame: Every 4 weeks for 26 weeks and every 4 weeks thereafter for patients who continue on study (up to 52 weeks).
measure: Skindex-29 Quality of Life Tool
time frame: Every 4 weeks for 26 weeks
measure: modified Composite Assessment of Index Lesion Severity (CAILS)
time frame: Every 4 weeks for 26 weeks and every 4 weeks therafter for patients who continue on study (up to 52 weeks).
arm group label: 1.0% SHAPE Gelled Solution once daily
arm group type: Experimental
arm group label: 0.5% SHAPE Gelled Solution twice daily
arm group type: Experimental
arm group label: 1.0% SHAPE Gelled Solution twice daily
arm group type: Experimental
intervention type: Drug
intervention name: SHAPE
description: topical gel
arm group label: 0.5% SHAPE Gelled Solution twice daily
arm group label: 1.0% SHAPE Gelled Solution once daily
arm group label: 1.0% SHAPE Gelled Solution twice daily
other name: SHP-141
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Lymphoma, T-Cell
mesh term: Lymphoma, T-Cell, Peripheral
mesh term: Lymphoma, T-Cell, Cutaneous