<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/NCT02982395</url>
  </required_header>
  <id_info>
    <org_study_id>DPMBLC301</org_study_id>
    <nct_id>NCT02982395</nct_id>
  </id_info>
  <brief_title>Study to Evaluate the Efficacy and Safety Of Intravesical Nanoxel®M In BCG Refractory NMIBC</brief_title>
  <official_title>A Phase Ⅲ Study to Evaluate the Efficacy and Safety Of Intravesical Nanoxel®M (Docetaxel-PM) In Bacillius Calmette-Guerin Refractory Non-Muscle Invasive Bladder Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Samyang Biopharmaceuticals Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Samyang Biopharmaceuticals Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether Nanoxel®M is effective in the treatment of&#xD;
      patients with recurrent Ta and T1 who experienced treatment failure with at least one prior&#xD;
      BCG intravesical treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">August 2018</completion_date>
  <primary_completion_date type="Actual">August 2018</primary_completion_date>
  <phase>Phase 3</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>Recurrence free rate</measure>
    <time_frame>1 year</time_frame>
    <description>Recurrence free rate will be summarized as the percentage of participants who achieved a confirmed recurrence free as assessed by urine cytology and cystoscopy. Recurrence means reappearance of high-risk disease (high grade, T1 or CIS) after the start of therapy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Recurrence free rate</measure>
    <time_frame>6 months, 2 years</time_frame>
    <description>Recurrence free rate will be summarized as the percentage of participants who achieved a confirmed recurrence free as assessed by urine cytology and cystoscopy.Recurrence means reappearance of high-risk disease (high grade, T1 or CIS) after the start of therapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>2 years</time_frame>
    <description>Time from random assignment to death resulting from any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events as assessed by CTCAE v4.0</measure>
    <time_frame>2 years</time_frame>
    <description>Adverse event (AE) is as any AE occurring or worsening from the first treatment of any study drug to the last dose of the last study drug. Severity grades according to NCI CTCAE version 4.0.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Non Muscle Invasive Bladder Cancer</condition>
  <arm_group>
    <arm_group_label>Nanoxel®M</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>75 mg in 100mL normal saline</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mitomycin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>40 mg in 100mL normal saline</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nanoxel®M</intervention_name>
    <description>Intravesical</description>
    <arm_group_label>Nanoxel®M</arm_group_label>
    <other_name>Polysorbate 80, ethanol free Docetaxel</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mitomycin-C</intervention_name>
    <description>Intravesical</description>
    <arm_group_label>Mitomycin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed diagnosis of superficial transitional cell carcinoma of the&#xD;
             bladder (Ta, T1)&#xD;
&#xD;
          -  Recurrent superficial bladder cancer refractory to Bacillus Calmette-Guerin (BCG)&#xD;
&#xD;
          -  No previous intravesical therapy for 6 weeks&#xD;
&#xD;
          -  No history of prior radiation to the pelvis&#xD;
&#xD;
          -  Peripheral neuropathy ≤ grade 1&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 t0 2&#xD;
&#xD;
          -  Adequate hematopoietic and hepatic parameters&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Muscle invasive disease (T2-T4)&#xD;
&#xD;
          -  Any other malignancy diagnosed within 2 years of study entry (Except basal or squamous&#xD;
             cell skin cancers or noninvasive cancer of the cervix)&#xD;
&#xD;
          -  Participation in any other research protocol involving administration of an&#xD;
             investigational agent within 3 months before study entry&#xD;
&#xD;
          -  History of sensitivity reaction to docetaxel&#xD;
&#xD;
          -  Prescribed immunosuppressive medications because of a confounding medical condition&#xD;
&#xD;
          -  Female patients who were pregnant or lactating&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ja Hyeon Ku</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>November 24, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>August 28, 2019</last_update_submitted>
  <last_update_submitted_qc>August 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Nanoxel M</keyword>
  <keyword>Docetaxel PM</keyword>
  <keyword>Docetaxel</keyword>
  <keyword>Mitomycin C</keyword>
  <keyword>BCG</keyword>
  <keyword>BCG refractory</keyword>
  <keyword>Non muscle invasive bladder cancer</keyword>
  <keyword>intravesical</keyword>
  <keyword>superficial bladder cancer</keyword>
  <keyword>Urothelial carcinoma</keyword>
  <keyword>Transitional cell carcinoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Bladder Neoplasms</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>Ethanol</mesh_term>
    <mesh_term>Docetaxel</mesh_term>
    <mesh_term>Mitomycins</mesh_term>
    <mesh_term>Mitomycin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02982395
org study id: DPMBLC301
nct id: NCT02982395
lead sponsor: 
has dmc: No
The purpose of this study is to determine whether Nanoxel®M is effective in the treatment of
      patients with recurrent Ta and T1 who experienced treatment failure with at least one prior
      BCG intravesical treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Recurrence free rate
time frame: 1 year
description: Recurrence free rate will be summarized as the percentage of participants who achieved a confirmed recurrence free as assessed by urine cytology and cystoscopy. Recurrence means reappearance of high-risk disease (high grade, T1 or CIS) after the start of therapy.
measure: Recurrence free rate
time frame: 6 months, 2 years
description: Recurrence free rate will be summarized as the percentage of participants who achieved a confirmed recurrence free as assessed by urine cytology and cystoscopy.Recurrence means reappearance of high-risk disease (high grade, T1 or CIS) after the start of therapy.
measure: Overall survival
time frame: 2 years
description: Time from random assignment to death resulting from any cause.
measure: Number of participants with adverse events as assessed by CTCAE v4.0
time frame: 2 years
description: Adverse event (AE) is as any AE occurring or worsening from the first treatment of any study drug to the last dose of the last study drug. Severity grades according to NCI CTCAE version 4.0.
arm group label: Nanoxel®M
arm group type: Experimental
description: 75 mg in 100mL normal saline
arm group label: Mitomycin
arm group type: Active Comparator
description: 40 mg in 100mL normal saline
intervention type: Drug
intervention name: Nanoxel®M
description: Intravesical
arm group label: Nanoxel®M
other name: Polysorbate 80, ethanol free Docetaxel
intervention type: Drug
intervention name: Mitomycin-C
description: Intravesical
arm group label: Mitomycin
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Ja Hyeon Ku
role: Principal Investigator
affiliation: Seoul National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Urinary Bladder Neoplasms
mesh term: Non-Muscle Invasive Bladder Neoplasms
mesh term: Ethanol
mesh term: Docetaxel
mesh term: Mitomycins
mesh term: Mitomycin
sharing ipd: No