<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/NCT03034135</url>
  </required_header>
  <id_info>
    <org_study_id>CAN-201</org_study_id>
    <nct_id>NCT03034135</nct_id>
  </id_info>
  <brief_title>Safety, Tolerability and Efficacy of Disulfiram and Copper Gluconate in Recurrent Glioblastoma</brief_title>
  <official_title>A Phase II, Multicenter, Open-Label, Single-Arm Study to Evaluate the Safety, Tolerability, and Efficacy of DIsulfiram and Copper Gluconate in Recurrent Glioblastoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cantex Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cantex 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>
      This study of DSF-Cu in combination with TMZ for recurrent GBM will evaluate the antitumor&#xD;
      effect in patients who have recurrent GBM. Patients will take DSF-Cu daily during their&#xD;
      routine standard of care with TMZ therapy for approximately 6 months. Patients will be&#xD;
      evaluated for response every 8 weeks. Patients will be followed up 2 years after the last&#xD;
      dose of DSF-Cu.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 9, 2017</start_date>
  <completion_date type="Actual">July 10, 2018</completion_date>
  <primary_completion_date type="Actual">July 10, 2018</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>Objective Response Rate</measure>
    <time_frame>6 months</time_frame>
    <description>ORR will be defined as the percentage of patients with complete response (CR) or partial response (PR) according to the RANO criteria.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival</measure>
    <time_frame>6 months</time_frame>
    <description>Percentage of patients that are free from progressive disease per RANO criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>6 months and 12 months</time_frame>
    <description>Percentage of patients that are alive</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Serious Adverse Events</measure>
    <time_frame>14 months</time_frame>
    <description>Number of Participants with Grade 3 and 4 serious adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median Progression Free Survival</measure>
    <time_frame>12 months</time_frame>
    <description>Duration of progression free survival according to RANO criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median Duration of Overall Survival</measure>
    <time_frame>14 months</time_frame>
    <description>Duration of overall survival for patients that are alive</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Recurrent Glioblastoma</condition>
  <arm_group>
    <arm_group_label>DSF-Cu</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Disulfiram/copper (oral capsules) dosed 80 mg/1.5 mg three times a day for approximately 6 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Disulfiram/Copper</intervention_name>
    <description>Disulfiram/copper gluconate is taken three times a day.</description>
    <arm_group_label>DSF-Cu</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Temozolomide (TMZ)</intervention_name>
    <description>TMZ is given per standard of care</description>
    <arm_group_label>DSF-Cu</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed GBM (WHO grade IV).&#xD;
&#xD;
          -  The subject must have completed RT with concurrent TMZ at least 12 weeks prior to the&#xD;
             planned start of treatment on this study UNLESS there is pathological verification of&#xD;
             recurrent tumor and at least 4 weeks have elapsed since the end of RT with concurrent&#xD;
             TMZ.&#xD;
&#xD;
          -  Experienced first unequivocal progression of tumor by magnetic resonance imaging (MRI)&#xD;
             [as assessed via Radiologic Assessment in Neuro-Oncology (RANO) criteria within 3&#xD;
             months from the last dose of TMZ.&#xD;
&#xD;
          -  Karnofsky performance status (KPS) of at least 60%.&#xD;
&#xD;
          -  Willing to remain abstinent from consuming alcohol.&#xD;
&#xD;
          -  Recovered from the toxic effects of prior therapy to &lt; grade 2 toxicity per NCI CTCAE&#xD;
             prior to study registration (except lymphopenia).&#xD;
&#xD;
          -  Meets laboratory criteria for the following parameters: ANC, platelets, hemoglobin,&#xD;
             total bilirubin, alkaline phosphatase, aspartate aminotransferase, alanine&#xD;
             aminotransferase, BUN and creatinine.&#xD;
&#xD;
          -  11. Females of childbearing potential must be willing to use an acceptable method of&#xD;
             birth control (i.e., intra-uterine device, diaphragm with spermicide, condom with&#xD;
             spermicide, or abstinence) for the duration of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Radiographic evidence of leptomeningeal dissemination, gliomatosis cerebri,&#xD;
             infratentorial tumor, or disease at sites remote from the supratentorial brain.&#xD;
&#xD;
          -  Enrolled in another clinical trial testing a novel therapy or drug within the past 4&#xD;
             weeks.&#xD;
&#xD;
          -  Received more than one course of radiation therapy or more than a total dose of 75 Gy.&#xD;
&#xD;
          -  History of allergic reaction/hypersensitivity to temozolomide, dacarbazine, DSF or Cu.&#xD;
&#xD;
          -  Treatment with the following medications are contraindicated with DSF: metronidazole,&#xD;
             isoniazid, dronabinol, carbocisteine, lopinavir, paraldehyde, ritonavir, sertraline,&#xD;
             tindazole, tizanidine, atazanavir.&#xD;
&#xD;
          -  Fever within 3 days prior to study enrollment.&#xD;
&#xD;
          -  Active or severe hepatic or renal disease.&#xD;
&#xD;
          -  Grade 2 or higher peripheral neuropathy or ataxia per NCI CTCAE&#xD;
&#xD;
          -  History of idiopathic seizure disorder schizophrenia, or psychosis unrelated to&#xD;
             glioblastoma, corticosteroid, or anti-epileptic medications.&#xD;
&#xD;
          -  History of Wilson's disease.&#xD;
&#xD;
          -  History of hemochromatosis.&#xD;
&#xD;
          -  Pregnant or breastfeeding.&#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>Jiayi Huang, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Washington University School of Medicine in St. Louis</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beaumont Hospital</name>
      <address>
        <city>Royal Oak</city>
        <state>Michigan</state>
        <zip>48073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>John Theurer Cancer Center</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lenox Hill Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10075</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Cincinnati</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt Ingram Cancer Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor University Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Huntsman Cancer Institute</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112-5550</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>January 25, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <results_first_submitted>April 2, 2021</results_first_submitted>
  <results_first_submitted_qc>August 17, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">September 13, 2021</results_first_posted>
  <disposition_first_submitted>July 23, 2019</disposition_first_submitted>
  <disposition_first_submitted_qc>August 17, 2021</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">September 13, 2021</disposition_first_posted>
  <last_update_submitted>August 17, 2021</last_update_submitted>
  <last_update_submitted_qc>August 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glioblastoma</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Copper</mesh_term>
    <mesh_term>Temozolomide</mesh_term>
    <mesh_term>Disulfiram</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 28, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/35/NCT03034135/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>DSF-Cu</title>
          <description>Disulfiram/copper (oral capsules) dosed 80 mg/1.5 mg three times a day for approximately 6 months.&#xD;
Disulfiram/Copper: Disulfiram/copper gluconate is taken three times a day.&#xD;
Temozolomide (TMZ): TMZ is given per standard of care</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Disulfiram and Copper Gluconate</title>
          <description>Disulfiram/copper (oral capsules) dosed 80 mg/1.5 mg three times a day for approximately 6 months.&#xD;
Disulfiram/Copper: Disulfiram/copper gluconate is taken three times a day.&#xD;
Temozolomide (TMZ): TMZ is given per standard of care</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="23"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61" lower_limit="43" upper_limit="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Objective Response Rate</title>
        <description>ORR will be defined as the percentage of patients with complete response (CR) or partial response (PR) according to the RANO criteria.</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DSF-Cu</title>
            <description>Disulfiram/copper (oral capsules) dosed 80 mg/1.5 mg three times a day for approximately 6 months.&#xD;
Disulfiram/Copper: Disulfiram/copper gluconate is taken three times a day.&#xD;
Temozolomide (TMZ): TMZ is given per standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Objective Response Rate</title>
          <description>ORR will be defined as the percentage of patients with complete response (CR) or partial response (PR) according to the RANO criteria.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Complete response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Partial Response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression Free Survival</title>
        <description>Percentage of patients that are free from progressive disease per RANO criteria</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DSF-Cu</title>
            <description>Disulfiram/copper (oral capsules) dosed 80 mg/1.5 mg three times a day for approximately 6 months.&#xD;
Disulfiram/Copper: Disulfiram/copper gluconate is taken three times a day.&#xD;
Temozolomide (TMZ): TMZ is given per standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Progression Free Survival</title>
          <description>Percentage of patients that are free from progressive disease per RANO criteria</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14" lower_limit="0" upper_limit="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival</title>
        <description>Percentage of patients that are alive</description>
        <time_frame>6 months and 12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DSF-Cu</title>
            <description>Disulfiram/copper (oral capsules) dosed 80 mg/1.5 mg three times a day for approximately 6 months.&#xD;
Disulfiram/Copper: Disulfiram/copper gluconate is taken three times a day.&#xD;
Temozolomide (TMZ): TMZ is given per standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival</title>
          <description>Percentage of patients that are alive</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61" lower_limit="41" upper_limit="81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35" lower_limit="15" upper_limit="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Serious Adverse Events</title>
        <description>Number of Participants with Grade 3 and 4 serious adverse events</description>
        <time_frame>14 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DSF-Cu</title>
            <description>Disulfiram/copper (oral capsules) dosed 80 mg/1.5 mg three times a day for approximately 6 months.&#xD;
Disulfiram/Copper: Disulfiram/copper gluconate is taken three times a day.&#xD;
Temozolomide (TMZ): TMZ is given per standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Serious Adverse Events</title>
          <description>Number of Participants with Grade 3 and 4 serious adverse events</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median Progression Free Survival</title>
        <description>Duration of progression free survival according to RANO criteria</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DSF-Cu</title>
            <description>Disulfiram/copper (oral capsules) dosed 80 mg/1.5 mg three times a day for approximately 6 months.&#xD;
Disulfiram/Copper: Disulfiram/copper gluconate is taken three times a day.&#xD;
Temozolomide (TMZ): TMZ is given per standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Median Progression Free Survival</title>
          <description>Duration of progression free survival according to RANO criteria</description>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7" lower_limit="1.4" upper_limit="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median Duration of Overall Survival</title>
        <description>Duration of overall survival for patients that are alive</description>
        <time_frame>14 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DSF-Cu</title>
            <description>Disulfiram/copper (oral capsules) dosed 80 mg/1.5 mg three times a day for approximately 6 months.&#xD;
Disulfiram/Copper: Disulfiram/copper gluconate is taken three times a day.&#xD;
Temozolomide (TMZ): TMZ is given per standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Median Duration of Overall Survival</title>
          <description>Duration of overall survival for patients that are alive</description>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.1" lower_limit="5.8" upper_limit="8.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>14 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Group A</title>
          <description>Eligible patients must have progressed after standard chemoradiotherapy and within 3 months of the last dose of TMZ.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>Liver</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title vocab="MedDRA (10.0)">Fatigue</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatobiliary disorders</sub_title>
                <description>Liver enzyme elevation</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Stephen Marcus MD</name_or_title>
      <organization>Cantex Pharmaceuticals</organization>
      <phone>9543153660</phone>
      <email>smarcus@cantex.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03034135
org study id: CAN-201
nct id: NCT03034135
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
This study of DSF-Cu in combination with TMZ for recurrent GBM will evaluate the antitumor
      effect in patients who have recurrent GBM. Patients will take DSF-Cu daily during their
      routine standard of care with TMZ therapy for approximately 6 months. Patients will be
      evaluated for response every 8 weeks. Patients will be followed up 2 years after the last
      dose of DSF-Cu.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Objective Response Rate
time frame: 6 months
description: ORR will be defined as the percentage of patients with complete response (CR) or partial response (PR) according to the RANO criteria.
measure: Progression Free Survival
time frame: 6 months
description: Percentage of patients that are free from progressive disease per RANO criteria
measure: Overall Survival
time frame: 6 months and 12 months
description: Percentage of patients that are alive
measure: Number of Participants With Serious Adverse Events
time frame: 14 months
description: Number of Participants with Grade 3 and 4 serious adverse events
measure: Median Progression Free Survival
time frame: 12 months
description: Duration of progression free survival according to RANO criteria
measure: Median Duration of Overall Survival
time frame: 14 months
description: Duration of overall survival for patients that are alive
arm group label: DSF-Cu
arm group type: Experimental
description: Disulfiram/copper (oral capsules) dosed 80 mg/1.5 mg three times a day for approximately 6 months.
intervention type: Drug
intervention name: Disulfiram/Copper
description: Disulfiram/copper gluconate is taken three times a day.
arm group label: DSF-Cu
intervention type: Drug
intervention name: Temozolomide (TMZ)
description: TMZ is given per standard of care
arm group label: DSF-Cu
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jiayi Huang, MD
role: Study Chair
affiliation: Washington University School of Medicine in St. Louis
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Glioblastoma
mesh term: Recurrence
mesh term: Copper
mesh term: Temozolomide
mesh term: Disulfiram
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 