<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/NCT01731652</url>
  </required_header>
  <id_info>
    <org_study_id>TMX-101-003</org_study_id>
    <nct_id>NCT01731652</nct_id>
  </id_info>
  <brief_title>Study With TMX-101 in Patients With Carcinoma In Situ (CIS) Bladder Cancer</brief_title>
  <official_title>Phase II Pilot Study With TMX 101 in Patients With Carcinoma In Situ (CIS) Bladder Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Telormedix SA</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Telormedix SA</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase II pilot study to explore the effect of intravesical TMX-101 in patients with&#xD;
      CIS bladder cancer, as assessed by histology and cytology after TMX-101 treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is an open label, pilot study of TMX-101 in the treatment of carcinoma in situ.&#xD;
      TMX-101 is a new formulation of Imiquimod optimized for intravesical delivery. Imiquimod&#xD;
      possesses immune-stimulatory properties. TMX-101 is being developed as a potential treatment&#xD;
      for patients with non-invasive bladder cancer, including patients with CIS bladder cancer.&#xD;
&#xD;
      Following confirmation of CIS by histology, patients will receive weekly instillations of&#xD;
      TMX-101 for 6 weeks. Five to seven weeks after the last instillation, biopsies and cytology&#xD;
      will be performed. Response to treatment will be determined based on cytology and tissue&#xD;
      sample histology findings.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2013</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">February 2014</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>To assess the activity of TMX-101, as determined by the number of patients who experience complete response (CR).</measure>
    <time_frame>5 to 7 weeks after the last TMX -101 instillation</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients experiencing adverse events (AEs), including serious adverse events (SAEs) and AEs leading to discontinuation from the study.</measure>
    <time_frame>Patients will be followed through treatment and follow-up, for an expected total period of up to 13 weeks.</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Carcinoma in Situ</condition>
  <condition>Non Muscle Invasive Bladder Cancer</condition>
  <arm_group>
    <arm_group_label>TMX-101</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TMX-101 0.4% (200 mg in 50 ml) instilled in the bladder once weekly for 6 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TMX-101</intervention_name>
    <arm_group_label>TMX-101</arm_group_label>
    <other_name>Imiquimod</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Males or female patient is aged ≥18 years.&#xD;
&#xD;
          2. Pathologically-proven, recurrent, primary, secondary or concomitant carcinoma in situ&#xD;
             disease, defined by having either Ta or T1 with CIS, or CIS alone. In cases with T1&#xD;
             tumor lesions, muscularis propria tissue should be in the resected specimen to confirm&#xD;
             that it is tumor-free.&#xD;
&#xD;
          3. Patient has undergone mapping of the bladder between Days -28 and -14, with at least&#xD;
             one biopsy providing pathological confirmation of CIS of the bladder. Slides must be&#xD;
             available for a central pathology review.&#xD;
&#xD;
          4. Patient has undergone bladder washing for cytology between Days -28 and -1. In&#xD;
             patients in whom Ta or T1 lesion(s) were resected, the bladder washing must have&#xD;
             occurred after the resection. Slides must be available for a central cytology review.&#xD;
&#xD;
          5. Patient has an ECOG performance status 0-2.&#xD;
&#xD;
          6. Patient has adequate bone marrow, hepatic, and renal function within 4 weeks before&#xD;
             Day 0.&#xD;
&#xD;
          7. Patient has read and understood the informed consent form and is willing and able to&#xD;
             give informed consent.&#xD;
&#xD;
          8. Patient fully understands the requirements of the study and is willing to comply with&#xD;
             all study visits and assessments.&#xD;
&#xD;
          9. If a woman of childbearing potential (WCBP), patient has a negative blood pregnancy&#xD;
             test at the Screening visit. For the purposes of this study, WCBP is defined as a&#xD;
             post-pubescent female, unless post-menopausal for at least 2 years, surgically&#xD;
             sterile, or sexually inactive.&#xD;
&#xD;
         10. If patient is a WCPB or male patient with a female partner of childbearing potential,&#xD;
             must be willing to avoid pregnancy by using an adequate method of contraception from 2&#xD;
             weeks before through 4 weeks after the last study drug treatment. Adequate&#xD;
             contraception is defined as follows: 2 barrier methods or 1 barrier method with a&#xD;
             spermicide or intrauterine device.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient has evidence of muscle-invasive disease (i.e., T2 or higher)&#xD;
&#xD;
          2. In the Investigator's opinion, patient is not able to hold instillation for at least 1&#xD;
             hour.&#xD;
&#xD;
          3. In the Investigator's opinion, patient cannot tolerate intravesical administration or&#xD;
             intravesical surgical manipulation.&#xD;
&#xD;
          4. Patient has received radiation therapy of pelvis within 12 months before the first&#xD;
             study drug treatment.&#xD;
&#xD;
          5. Patient requires perioperative intravesical chemotherapy.&#xD;
&#xD;
          6. Patient has a history of malignancy of the upper urinary tract.&#xD;
&#xD;
          7. Patient has bone marrow impairment as evidenced by:&#xD;
&#xD;
               -  Hemoglobin &lt;9.0 g/dL&#xD;
&#xD;
               -  Absolute neutrophil count (ANC) &lt;1.5×109/L&#xD;
&#xD;
               -  Platelet count &lt;120×109/L.&#xD;
&#xD;
          8. Patient has renal impairment, as evidenced by:&#xD;
&#xD;
               -  Serum creatinine &gt;2× the upper limit of normal (ULN), and/or&#xD;
&#xD;
               -  Calculated creatinine clearance &lt;40 mL/min.&#xD;
&#xD;
          9. Patient has liver function abnormality, as evidenced by:&#xD;
&#xD;
               -  Total bilirubin &gt;1.5×ULN, or&#xD;
&#xD;
               -  Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) &gt;2.5×ULN.&#xD;
&#xD;
         10. Patient has a bleeding disorder, as evidenced by an international normalized ratio&#xD;
             (INR) &gt;1.5×ULN.&#xD;
&#xD;
         11. Patient is known to be positive for human immunodeficiency virus (HIV) or has active&#xD;
             hepatitis B or C infection.&#xD;
&#xD;
         12. Patient has a clinically significant active infection at the time of the first study&#xD;
             drug treatment.&#xD;
&#xD;
         13. Patient has any medical or psychiatric condition that, in the Investigator's opinion,&#xD;
             might impair the patient's well-being or preclude adherence to the protocol or&#xD;
             completing the study as per protocol.&#xD;
&#xD;
         14. Patient has suspected hypersensitivity to imidazoquinoline compounds, poloxamer 407,&#xD;
             hydroxy propyl betacyclodextrin, or lactic acid.&#xD;
&#xD;
         15. If female, patient is pregnant or breast feeding.&#xD;
&#xD;
         16. Patient participated in any other protocol involving administration of an&#xD;
             investigational agent within 3 months before Day 0.&#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>BCG Oncology</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Urology Center of Colorado</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Urologic Consultants of SE PA</name>
      <address>
        <city>Bala Cynwyd</city>
        <state>Pennsylvania</state>
        <zip>19004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolina Urologic Research Center</name>
      <address>
        <city>Myrtle Beach</city>
        <state>South Carolina</state>
        <zip>29572</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2015</verification_date>
  <study_first_submitted>November 12, 2012</study_first_submitted>
  <study_first_submitted_qc>November 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2012</study_first_posted>
  <last_update_submitted>February 9, 2015</last_update_submitted>
  <last_update_submitted_qc>February 9, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 10, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>bladder cancer</keyword>
  <keyword>carcinoma in situ</keyword>
  <keyword>non muscle invasive bladder cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Urinary Bladder Neoplasms</mesh_term>
    <mesh_term>Carcinoma in Situ</mesh_term>
    <mesh_term>Non-Muscle Invasive Bladder Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Imiquimod</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/NCT01731652
org study id: TMX-101-003
nct id: NCT01731652
lead sponsor: 
has dmc: No
This is a Phase II pilot study to explore the effect of intravesical TMX-101 in patients with
      CIS bladder cancer, as assessed by histology and cytology after TMX-101 treatment.
This study is an open label, pilot study of TMX-101 in the treatment of carcinoma in situ.
      TMX-101 is a new formulation of Imiquimod optimized for intravesical delivery. Imiquimod
      possesses immune-stimulatory properties. TMX-101 is being developed as a potential treatment
      for patients with non-invasive bladder cancer, including patients with CIS bladder cancer.

      Following confirmation of CIS by histology, patients will receive weekly instillations of
      TMX-101 for 6 weeks. Five to seven weeks after the last instillation, biopsies and cytology
      will be performed. Response to treatment will be determined based on cytology and tissue
      sample histology findings.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: To assess the activity of TMX-101, as determined by the number of patients who experience complete response (CR).
time frame: 5 to 7 weeks after the last TMX -101 instillation
measure: Proportion of patients experiencing adverse events (AEs), including serious adverse events (SAEs) and AEs leading to discontinuation from the study.
time frame: Patients will be followed through treatment and follow-up, for an expected total period of up to 13 weeks.
arm group label: TMX-101
arm group type: Experimental
description: TMX-101 0.4% (200 mg in 50 ml) instilled in the bladder once weekly for 6 weeks
intervention type: Drug
intervention name: TMX-101
arm group label: TMX-101
other name: Imiquimod
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Urinary Bladder Neoplasms
mesh term: Carcinoma in Situ
mesh term: Non-Muscle Invasive Bladder Neoplasms
mesh term: Imiquimod