<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/NCT03020823</url>
  </required_header>
  <id_info>
    <org_study_id>SCB01A-22</org_study_id>
    <nct_id>NCT03020823</nct_id>
  </id_info>
  <brief_title>To Evaluate the Efficacy and Safety of SCB01A in Subjects With r/m Squamous Cell Head and Neck Cancer</brief_title>
  <official_title>An Open-Label, Phase II Study to Evaluate the Efficacy and Safety of SCB01A in Subjects With Recurrent or Metastatic Squamous Cell Head and Neck Cancer Who Have Failed Platinum-Based Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>SynCore Biotechnology Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>SynCore Biotechnology Co., Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to evaluate the efficacy and safety of i.v. infusion for 24-hour of&#xD;
      SCB01A in subjects with squamous cell carcinoma of head and neck who have failed previous&#xD;
      platinum based therapies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      From pre-clinical pharmacology and phase I clinical study SCB01A has demonstrated promising&#xD;
      anticancer action with a vascular disrupting activity that has the potential for treatment of&#xD;
      various malignancies, particularly for patients with drug resistance. The drug has been&#xD;
      studied in human subjects in a dose escalation phase I study and has shown to be safe for up&#xD;
      to 2 cycles of 24 mg/m2 (each cycle consisting of one intravenous [i.v.] administration of&#xD;
      SCB01A via a central line every 3 weeks). In the phase I study, partial response (PR)&#xD;
      (shrinkage of tumor size to 50%) was observed in cycle 9 (3 mg/m2) of one subject with right&#xD;
      buccal squamous cell carcinoma and 19/33 (58%) subjects had stable disease (SD) for more than&#xD;
      2 cycles.&#xD;
&#xD;
      Pre clinical study of SCB01A showed that the concentrations at which tubulin inhibition&#xD;
      occurred were around 80 nM for 24-hour exposure or 200 nM for 6-hour exposure. However,&#xD;
      pharmacokinetic (PK) results of phase I study showed that the average elimination half-life&#xD;
      (t1/2) of a 3-hours i.v. infusion of SCB01A is approximately 2.5 hours and almost no SCB01A&#xD;
      can be detected after 10 hours, indicating most subjects were treated in short API exposure&#xD;
      time and may have been insufficient to achieve efficacy. Therefore, to extend the exposure&#xD;
      duration above effective concentration in blood may increase the treatment efficacy.&#xD;
&#xD;
      The aim of this study is to evaluate the efficacy and safety of i.v. infusion for 24-hour of&#xD;
      SCB01A in subjects with squamous cell carcinoma of head and neck who have failed previous&#xD;
      platinum based therapies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    withdrawal by sponsor&#xD;
  </why_stopped>
  <start_date type="Actual">April 30, 2017</start_date>
  <completion_date type="Actual">November 20, 2018</completion_date>
  <primary_completion_date type="Actual">November 20, 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 (ORR) During Treatment Phase</measure>
    <time_frame>Up to approximately 15 months (assessed continuously during treatment)</time_frame>
    <description>Objective response rate (ORR) was defined as complete response (CR) + partial response (PR), according to RECIST v1.1 criteria.&#xD;
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt;10 mm.&#xD;
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival (PFS)</measure>
    <time_frame>From the start of treatment up to either first observation of progressive disease or occurrence of death, up to approximately 15 months (assessed continuously during treatment)</time_frame>
    <description>PFS is defined as the time from the start of treatment up to the date of first progression based on RECIST v1.1 or the date of death, which ever comes first.&#xD;
Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>From the start of treatment up to death from any cause or last day known to be alive, up to approximately 15 months (assessed continuously during treatment)</time_frame>
    <description>OS is defined as the as the time from the start of treatment up to the time that the subject is still alive.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Best Overall Tumor Response</measure>
    <time_frame>Up to approximately 15 months (assessed continuously during treatment)</time_frame>
    <description>Best overall tumor response is defined as an objective response or stable disease of treatment phase.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Head and Neck Neoplasms</condition>
  <arm_group>
    <arm_group_label>SCB01A alone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>intra-subject dose escalation starting from 12 mg/m2, then to18 mg/m2, and finally to 24 mg/m2 if no DLT</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SCB01A</intervention_name>
    <description>intra-subject dose escalation, 12, 18, 24 mg/m2, 24h-IV infusion (in the vein) on day 1 and 8 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.</description>
    <arm_group_label>SCB01A alone</arm_group_label>
    <other_name>6-Methoxy-3-(3',4',5'-trimethoxybenzoyl) indole</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Aged ≥20 years;&#xD;
&#xD;
          2. Signed informed consent obtained prior to initiation of any study-specific procedures&#xD;
             and treatment;&#xD;
&#xD;
          3. Histological or cytological confirmed squamous cell carcinoma of head and neck,&#xD;
             excluding nasopharyngeal carcinoma;&#xD;
&#xD;
          4. Subjects with unresectable, unfeasible radiotherapy, recurrent or metastatic head and&#xD;
             neck squamous cell carcinoma, after previous treatment with platinum agent;&#xD;
&#xD;
          5. Subjects must have at least one measurable tumor lesion as defined by RECIST version&#xD;
             1.1 as assessed by the investigator (local radiological image assessment) or&#xD;
             clinically evaluable disease. Physical and neurological examinations, and radiographic&#xD;
             studies have to be performed within 28 days of Cycle 1 Day 1;&#xD;
&#xD;
          6. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1;&#xD;
&#xD;
          7. Life expectancy of 12 weeks or longer;&#xD;
&#xD;
          8. Concurrent local therapy is not allowed, but concurrent palliative radiation therapy&#xD;
             to non-measurable sites of disease such as painful bone metastasis is permitted;&#xD;
&#xD;
          9. All eligible subjects of childbearing potential have to use effective contraception;&#xD;
             that is, double barrier contraceptive methods;&#xD;
&#xD;
         10. Documented progressive disease within past 6 months;&#xD;
&#xD;
         11. Adequate bone marrow reserve, cardiac, renal and liver function:&#xD;
&#xD;
               1. Absolute neutrophil count (ANC) &gt; 1.5 x 109/L;&#xD;
&#xD;
               2. White blood cell (WBC) &gt; 3 x 109/L;&#xD;
&#xD;
               3. Platelet count &gt; 75 x 109/L;&#xD;
&#xD;
               4. Hemoglobin &gt; 9 g/dL ( &gt; 5.6 mmol/l);&#xD;
&#xD;
               5. Prothrombin time (PT)/international normalized ratio (INR) ≤1.5 x upper limit of&#xD;
                  normal (ULN);&#xD;
&#xD;
               6. Creatinine clearance (Cockcroft &amp; Gault formula) &gt;50 mL/min;&#xD;
&#xD;
               7. Alanine aminotransferase (ALT, SGPT) and aspartate aminotransferase (AST, SGOT)&#xD;
                  and Alkaline Phosphatase (ALP) &lt; 3 x ULN; AST/ALT≦5 x ULN if liver metastasis;&#xD;
&#xD;
               8. Serum albumin ≥ 3 g/dL;&#xD;
&#xD;
               9. Total Bilirubin ≤ 1.5 x ULN;&#xD;
&#xD;
              10. QTc &lt;450 msec&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Known primary CNS malignancy or CNS involvement (except for brain metastases that have&#xD;
             been treated and are stable and subject is off steroids);&#xD;
&#xD;
          2. Chemotherapy, radiation therapy, major surgery or investigational agents including&#xD;
             immune or target therapies less than 4 weeks prior to study drug treatment;&#xD;
&#xD;
          3. History of malignancy other than head and neck cancer with the exception of early&#xD;
             stage non-melanoma skin cancer or carcinoma in situ of cervix;&#xD;
&#xD;
          4. History of liver cirrhosis;&#xD;
&#xD;
          5. Active hepatitis B or hepatitis C infection;&#xD;
&#xD;
          6. Clinical significant pulmonary obstructive or clinical significant pulmonary&#xD;
             restrictive diseases (grade &gt;2);&#xD;
&#xD;
          7. Clinically significant cardiac disease (NYHA class &gt; 2);&#xD;
&#xD;
          8. Other serious illness or medial conditions, such as active infection, unresolved bowel&#xD;
             obstruction, or psychiatric disorders;&#xD;
&#xD;
          9. Known HIV positivity;&#xD;
&#xD;
         10. Pregnant or breast-feeding subjects, and men and women of child-bearing potential not&#xD;
             using effective contraception while on study treatment;&#xD;
&#xD;
         11. Known hypersensitivity to any component of SCB01A or excipients including Solutol®,&#xD;
             alcohol, and PEG300;&#xD;
&#xD;
         12. History of exposure to SCB01A or its analogues;&#xD;
&#xD;
         13. History of active or significant neurological disorder or psychiatric disorder that&#xD;
             would prohibit the understanding and giving of informed consent, or would interfere&#xD;
             with the clinical and radiological evaluation of central nervous system during the&#xD;
             trial;&#xD;
&#xD;
         14. Peripheral neuropathy (≥ grade 2);&#xD;
&#xD;
         15. Any other reason the investigator deems the subject to be unsuitable for the study.&#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>Her-Shyong Shiah, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Taipei Medical University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Cheng Kung University Hospital</name>
      <address>
        <city>Tainan</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Suang Ho Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taipei Medical University Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taipei Veterans General Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <results_first_submitted>April 12, 2023</results_first_submitted>
  <results_first_submitted_qc>May 5, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">June 2, 2023</results_first_posted>
  <last_update_submitted>June 1, 2023</last_update_submitted>
  <last_update_submitted_qc>June 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>SCB01A</keyword>
  <keyword>squamous cell carcinoma of head and neck</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Head and Neck Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 19, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/23/NCT03020823/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan: TableFigure</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 14, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/23/NCT03020823/SAP_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan: Listing</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 14, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/23/NCT03020823/SAP_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan: CSR_9.7_Statistical methods planned in the protocol</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 7, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/23/NCT03020823/SAP_003.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Intra-subject Dose Escalation Regimen</title>
          <description>All subjects enrolled in this study would be treated from the same starting dose 12 mg/m² (Dose 1) given on Days 1 and 8 in a 21-day cycle by 24 h i.v. infusion. If the subject experiences no dose-limiting toxicity (DLT) during the period, dose escalation of SCB01A to 18 mg/m² (Dose 2) occurred from cycle 2; and increased to 24 mg/m² (Dose 3) on cycle 3.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>12 mg/m² Only</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>12 &amp; 18 mg/m²</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>12, 18 &amp; 24 mg/m²</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0">4 subjects discontinued from the study owing to disease progression based on clinical judgement, 4 subjects discontinued because of diagnosed PD based on RECIST, and 2 subjects discontinued because of intolerable adverse event(s) or failure to tolerate the study treatment.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</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>SCB01A Alone</title>
          <description>intra-subject dose escalation starting from 12 mg/m2, then to18 mg/m2, and finally to 24 mg/m2 if no DLT&#xD;
SCB01A: intra-subject dose escalation, 12, 18, 24 mg/m2, 24h-IV infusion (in the vein) on day 1 and 8 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="10"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </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="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Taiwan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>ECOG at Screening visit</title>
          <description>ECOG 0: Normal activity. Fully active, able to carry on all pre-disease performance without restriction.&#xD;
ECOG 1: Symptoms, but ambulatory. Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature (e.g., light housework, office work).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>0</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Objective Response Rate (ORR) During Treatment Phase</title>
        <description>Objective response rate (ORR) was defined as complete response (CR) + partial response (PR), according to RECIST v1.1 criteria.&#xD;
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt;10 mm.&#xD;
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.</description>
        <time_frame>Up to approximately 15 months (assessed continuously during treatment)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>SCB01A Alone</title>
            <description>intra-subject dose escalation starting from 12 mg/m2, then to18 mg/m2, and finally to 24 mg/m2 if no DLT&#xD;
SCB01A: intra-subject dose escalation, 12, 18, 24 mg/m2, 24h-IV infusion (in the vein) on day 1 and 8 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.</description>
          </group>
        </group_list>
        <measure>
          <title>Objective Response Rate (ORR) During Treatment Phase</title>
          <description>Objective response rate (ORR) was defined as complete response (CR) + partial response (PR), according to RECIST v1.1 criteria.&#xD;
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt;10 mm.&#xD;
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.</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="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <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 (PFS)</title>
        <description>PFS is defined as the time from the start of treatment up to the date of first progression based on RECIST v1.1 or the date of death, which ever comes first.&#xD;
Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).</description>
        <time_frame>From the start of treatment up to either first observation of progressive disease or occurrence of death, up to approximately 15 months (assessed continuously during treatment)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>SCB01A Alone</title>
            <description>intra-subject dose escalation starting from 12 mg/m2, then to18 mg/m2, and finally to 24 mg/m2 if no DLT&#xD;
SCB01A: intra-subject dose escalation, 12, 18, 24 mg/m2, 24h-IV infusion (in the vein) on day 1 and 8 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.</description>
          </group>
        </group_list>
        <measure>
          <title>Progression Free Survival (PFS)</title>
          <description>PFS is defined as the time from the start of treatment up to the date of first progression based on RECIST v1.1 or the date of death, which ever comes first.&#xD;
Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).</description>
          <units>days</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="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="125" lower_limit="28" upper_limit="251"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival (OS)</title>
        <description>OS is defined as the as the time from the start of treatment up to the time that the subject is still alive.</description>
        <time_frame>From the start of treatment up to death from any cause or last day known to be alive, up to approximately 15 months (assessed continuously during treatment)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>SCB01A Alone</title>
            <description>intra-subject dose escalation starting from 12 mg/m2, then to18 mg/m2, and finally to 24 mg/m2 if no DLT&#xD;
SCB01A: intra-subject dose escalation, 12, 18, 24 mg/m2, 24h-IV infusion (in the vein) on day 1 and 8 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS)</title>
          <description>OS is defined as the as the time from the start of treatment up to the time that the subject is still alive.</description>
          <units>days</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="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="292" lower_limit="29" upper_limit="292"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Best Overall Tumor Response</title>
        <description>Best overall tumor response is defined as an objective response or stable disease of treatment phase.</description>
        <time_frame>Up to approximately 15 months (assessed continuously during treatment)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>SCB01A Alone</title>
            <description>intra-subject dose escalation starting from 12 mg/m2, then to18 mg/m2, and finally to 24 mg/m2 if no DLT&#xD;
SCB01A: intra-subject dose escalation, 12, 18, 24 mg/m2, 24h-IV infusion (in the vein) on day 1 and 8 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.</description>
          </group>
        </group_list>
        <measure>
          <title>Best Overall Tumor Response</title>
          <description>Best overall tumor response is defined as an objective response or stable disease of treatment phase.</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="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to approximately 15 months (assessed continuously during treatment)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>SCB01A 12 mg/m² Only</title>
          <description>All subjects enrolled in this study would be treated from the same starting dose 12 mg/m² (Dose 1) given on Days 1 and 8 in a 21-day cycle by 24 h i.v. infusion. If the subject experiences no dose-limiting toxicity (DLT) during the period, dose escalation of SCB01A to 18 mg/m² (Dose 2) occurred from cycle 2; and increased to 24 mg/m² (Dose 3) on cycle 3.</description>
        </group>
        <group group_id="E2">
          <title>SCB01A 12 &amp; 18 mg/m²</title>
          <description>All subjects enrolled in this study would be treated from the same starting dose 12 mg/m² (Dose 1) given on Days 1 and 8 in a 21-day cycle by 24 h i.v. infusion. If the subject experiences no dose-limiting toxicity (DLT) during the period, dose escalation of SCB01A to 18 mg/m² (Dose 2) occurred from cycle 2; and increased to 24 mg/m² (Dose 3) on cycle 3.</description>
        </group>
        <group group_id="E3">
          <title>SCB01A 12, 18 &amp; 24 mg/m²</title>
          <description>All subjects enrolled in this study would be treated from the same starting dose 12 mg/m² (Dose 1) given on Days 1 and 8 in a 21-day cycle by 24 h i.v. infusion. If the subject experiences no dose-limiting toxicity (DLT) during the period, dose escalation of SCB01A to 18 mg/m² (Dose 2) occurred from cycle 2; and increased to 24 mg/m² (Dose 3) on cycle 3.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 19.1</default_vocab>
        <default_assessment>Non-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="2" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>hepatic function abnormal</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyponatremia</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>somnolence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>syncope</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>dizziness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>airway obstruction</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 19.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Tinnitus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Chronic gastritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Edema peripheral</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infection</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Ear injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Hyponatremia</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Ear neoplasm malignant</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </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 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>Dr. Lin</name_or_title>
      <organization>Syncore</organization>
      <phone>0227603688</phone>
      <email>JWLin@syncorebio.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/NCT03020823
org study id: SCB01A-22
nct id: NCT03020823
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The aim of this study is to evaluate the efficacy and safety of i.v. infusion for 24-hour of
      SCB01A in subjects with squamous cell carcinoma of head and neck who have failed previous
      platinum based therapies.
From pre-clinical pharmacology and phase I clinical study SCB01A has demonstrated promising
      anticancer action with a vascular disrupting activity that has the potential for treatment of
      various malignancies, particularly for patients with drug resistance. The drug has been
      studied in human subjects in a dose escalation phase I study and has shown to be safe for up
      to 2 cycles of 24 mg/m2 (each cycle consisting of one intravenous [i.v.] administration of
      SCB01A via a central line every 3 weeks). In the phase I study, partial response (PR)
      (shrinkage of tumor size to 50%) was observed in cycle 9 (3 mg/m2) of one subject with right
      buccal squamous cell carcinoma and 19/33 (58%) subjects had stable disease (SD) for more than
      2 cycles.

      Pre clinical study of SCB01A showed that the concentrations at which tubulin inhibition
      occurred were around 80 nM for 24-hour exposure or 200 nM for 6-hour exposure. However,
      pharmacokinetic (PK) results of phase I study showed that the average elimination half-life
      (t1/2) of a 3-hours i.v. infusion of SCB01A is approximately 2.5 hours and almost no SCB01A
      can be detected after 10 hours, indicating most subjects were treated in short API exposure
      time and may have been insufficient to achieve efficacy. Therefore, to extend the exposure
      duration above effective concentration in blood may increase the treatment efficacy.

      The aim of this study is to evaluate the efficacy and safety of i.v. infusion for 24-hour of
      SCB01A in subjects with squamous cell carcinoma of head and neck who have failed previous
      platinum based therapies.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Objective Response Rate (ORR) During Treatment Phase
time frame: Up to approximately 15 months (assessed continuously during treatment)
description: Objective response rate (ORR) was defined as complete response (CR) + partial response (PR), according to RECIST v1.1 criteria.
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
measure: Progression Free Survival (PFS)
time frame: From the start of treatment up to either first observation of progressive disease or occurrence of death, up to approximately 15 months (assessed continuously during treatment)
description: PFS is defined as the time from the start of treatment up to the date of first progression based on RECIST v1.1 or the date of death, which ever comes first.
Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
measure: Overall Survival (OS)
time frame: From the start of treatment up to death from any cause or last day known to be alive, up to approximately 15 months (assessed continuously during treatment)
description: OS is defined as the as the time from the start of treatment up to the time that the subject is still alive.
measure: Best Overall Tumor Response
time frame: Up to approximately 15 months (assessed continuously during treatment)
description: Best overall tumor response is defined as an objective response or stable disease of treatment phase.
arm group label: SCB01A alone
arm group type: Experimental
description: intra-subject dose escalation starting from 12 mg/m2, then to18 mg/m2, and finally to 24 mg/m2 if no DLT
intervention type: Drug
intervention name: SCB01A
description: intra-subject dose escalation, 12, 18, 24 mg/m2, 24h-IV infusion (in the vein) on day 1 and 8 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
arm group label: SCB01A alone
other name: 6-Methoxy-3-(3',4',5'-trimethoxybenzoyl) indole
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Her-Shyong Shiah, MD
role: Principal Investigator
affiliation: Taipei Medical University Hospital
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country: Taiwan
responsible party type: Sponsor
mesh term: Head and Neck Neoplasms
sharing ipd: No
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