<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/NCT01699152</url>
  </required_header>
  <id_info>
    <org_study_id>TG02-102</org_study_id>
    <nct_id>NCT01699152</nct_id>
  </id_info>
  <brief_title>Phase 1 Study of TG02 Citrate in Patients With Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma</brief_title>
  <official_title>Phase 1 Dose-Escalation and Pharmacokinetic Study of TG02 Citrate in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tragara Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tragara Pharmaceuticals, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a multi-center, open-label, dose escalation study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective is to determine the highest dose of TG02 citrate that can be safely&#xD;
      given to patients with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">July 2015</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>Maximum Tolerated Dose</measure>
    <time_frame>28 days</time_frame>
    <description>To assess the number of patients with dose-limiting toxicities (DLT) and the dose of TG02 citrate that can be safely given to patients with CLL or SLL.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>28 days</time_frame>
    <description>The number of patients with adverse events</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Chronic Lymphocytic Leukemia</condition>
  <condition>Small Lymphocytic Lymphoma</condition>
  <arm_group>
    <arm_group_label>TG02 citrate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TG02 citrate capsules given orally.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TG02 citrate</intervention_name>
    <description>TG02 citrate capsules</description>
    <arm_group_label>TG02 citrate</arm_group_label>
    <other_name>No other names</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must have histologically confirmed Chronic Lymphocytic Leukemia Small&#xD;
             Lymphocytic Lymphoma.&#xD;
&#xD;
          -  Patients must meet one or more of the following indications for treatment:&#xD;
&#xD;
               1. Progressive disease or marked splenomegaly and/or lymphadenopathy.&#xD;
&#xD;
               2. Anemia (hemoglobin &lt;11 mg/dL) or thrombocytopenia (platelets&lt;100,000/μL).&#xD;
&#xD;
               3. Unexplained weight loss exceeding 10% of body weight over the previous 6 months.&#xD;
&#xD;
               4. CTCAE Grade 2 or 3 fatigue.&#xD;
&#xD;
               5. Fevers &gt;100.5º F or night sweats for more than 2 weeks without evidence of&#xD;
                  infection.&#xD;
&#xD;
               6. Progressive lymphocytosis, with an increase exceeding 50% over a 2 month period&#xD;
                  or a doubling time of less than 6 months.&#xD;
&#xD;
               7. Need for cytoreduction prior to allogeneic stem cell transplant.&#xD;
&#xD;
          -  Patients must have relapsed or refractory disease after ≥1 prior line of treatment.&#xD;
&#xD;
          -  The interval from prior treatment to time of study drug administration should be at&#xD;
             least 5 half-lives for cytotoxic and noncytotoxic agents.&#xD;
&#xD;
          -  Low-dose corticosteroids (prednisone &lt;20 mg/ day or equivalent dose) are permitted&#xD;
             throughout study.&#xD;
&#xD;
          -  Clinically significant toxicities from prior chemotherapy must be resolved to Grade ≤&#xD;
             1.&#xD;
&#xD;
          -  Age &gt;18 years.&#xD;
&#xD;
          -  ECOG performance status ≤2.&#xD;
&#xD;
          -  Life expectancy ≥ 12 weeks.&#xD;
&#xD;
          -  Patients must have normal organ and marrow function as defined below:&#xD;
&#xD;
               -  absolute neutrophil count &gt;1,000/μL in absence of bone marrow involvement&#xD;
&#xD;
               -  platelets ≥30,000/μL in absence of bone marrow involvement&#xD;
&#xD;
               -  If patient has extensive bone marrow involvement, minimum ANC and platelet levels&#xD;
                  are not required.&#xD;
&#xD;
               -  total bilirubin ≤1.5 X institutional ULN unless due to Gilbert's syndrome,&#xD;
                  controlled autoimmune hemolytic anemia or immune thrombocytopenia&#xD;
&#xD;
               -  AST(SGOT)/ALT(SGPT) &lt;2.5 X institutional ULN unless due to disease&#xD;
&#xD;
               -  creatinine &lt;2.0 mg/dL OR creatinine clearance &gt;50 mL/min/1.73 m2&#xD;
&#xD;
          -  Negative serum or urine pregnancy test at the time of first dose for WOCBP.&#xD;
&#xD;
          -  Ability to understand the requirements of the study, provide written informed consent&#xD;
             and authorization of use and disclosure of protected health information, and agree to&#xD;
             abide by the study restrictions and to return for required assessments.&#xD;
&#xD;
          -  Ability to take oral medication.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have had chemotherapy or radiotherapy within 3 weeks (6 weeks for&#xD;
             nitrosoureas or mitomycin C) prior to entering the study or those who have not&#xD;
             recovered from adverse events (CTCAE Grade &gt; 1) due to agents administered more than 3&#xD;
             weeks earlier.&#xD;
&#xD;
          -  Patients who have received prior treatment with a CDK inhibitor within 12 months of&#xD;
             study enrollment.&#xD;
&#xD;
          -  High-dose corticosteroids (prednisone ≥20mg/day or equivalent dose) must be&#xD;
             discontinued ≥ 7 days of initiating therapy.&#xD;
&#xD;
          -  Patients with known central nervous system involvement.&#xD;
&#xD;
          -  History of allergic reactions attributed to compounds of similar chemical or biologic&#xD;
             composition as TG02 citrate.&#xD;
&#xD;
          -  Patients with G6PD deficiency.&#xD;
&#xD;
          -  Concurrent severe or uncontrolled medical disease (including but not limited to&#xD;
             history of ventricular arrhythmia or symptomatic conduction abnormality within 12&#xD;
             months, ongoing or active systemic infection, diabetes, hypertension, coronary artery&#xD;
             disease, congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or&#xD;
             psychiatric illness/social situations) that, in the opinion of the Investigator, would&#xD;
             compromise the safety of the patient or compromise the ability of the patient to&#xD;
             complete the study.&#xD;
&#xD;
          -  Pregnant and/or breast-feeding women.&#xD;
&#xD;
          -  Prior or second malignancy, except for adequately treated basal cell or squamous cell&#xD;
             skin cancer, in situ cervical or breast cancer, or other cancer for which the subject&#xD;
             has received curative therapy at least 3 years prior to study entry.&#xD;
&#xD;
          -  Known HIV or AIDs.&#xD;
&#xD;
          -  QTc interval prolongation &gt;450ms for males and &gt;470 ms for females.&#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_official>
    <last_name>T Parrott</last_name>
    <role>Study Director</role>
    <affiliation>Tragara Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GRU</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DFCI</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OSU</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCRI</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MDACC</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>May 2016</verification_date>
  <study_first_submitted>October 1, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <last_update_submitted>July 23, 2019</last_update_submitted>
  <last_update_submitted_qc>July 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic Lymphocytic Leukemia</keyword>
  <keyword>Small Lymphocytic Lymphoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Leukemia, Lymphoid</mesh_term>
    <mesh_term>Leukemia, Lymphocytic, Chronic, B-Cell</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/NCT01699152
org study id: TG02-102
nct id: NCT01699152
lead sponsor: 
has dmc: No
This is a multi-center, open-label, dose escalation study.
The primary objective is to determine the highest dose of TG02 citrate that can be safely
      given to patients with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum Tolerated Dose
time frame: 28 days
description: To assess the number of patients with dose-limiting toxicities (DLT) and the dose of TG02 citrate that can be safely given to patients with CLL or SLL.
measure: Adverse Events
time frame: 28 days
description: The number of patients with adverse events
arm group label: TG02 citrate
arm group type: Experimental
description: TG02 citrate capsules given orally.
intervention type: Drug
intervention name: TG02 citrate
description: TG02 citrate capsules
arm group label: TG02 citrate
other name: No other names
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: T Parrott
role: Study Director
affiliation: Tragara Pharmaceuticals
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Leukemia
mesh term: Leukemia, Lymphoid
mesh term: Leukemia, Lymphocytic, Chronic, B-Cell