<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/NCT02233712</url>
  </required_header>
  <id_info>
    <org_study_id>GC3</org_study_id>
    <nct_id>NCT02233712</nct_id>
  </id_info>
  <brief_title>Open-label, Dose-finding Study to Determine Antibody Response to G17DT Treatment in Patients With Gastric Cancer.</brief_title>
  <acronym>GC3</acronym>
  <official_title>An Open-label, Dose-finding, Schedule-changing, Multi-center Study to Determine the Antibody Response to G17DT Treatment of Patients With Gastric Cancer.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cancer Advances Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cancer Advances Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      An open label, dose-finding, schedule-changing, sequential, multiple dose, multi-center study&#xD;
      in patients with Stage I-III gastric cancer. The first group of patients received a starting&#xD;
      dose of 250 µg at weeks 0, 1, and 3. Thereafter, allocation to treatment with 100 µg or 500&#xD;
      µg was based on antibody response and dose tolerability.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 1999</start_date>
  <primary_completion_date type="Actual">March 2000</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Antibody Levels</measure>
    <time_frame>Up to Week 24</time_frame>
    <description>Gastrin-17 antibodies are produced as a result of treatment with G17DT and the proportion of patients producing gastrin-17 antibodies was considered to be an appropriate measure of the immunogenicity of the dosing schedule under study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Injection Site Reaction</measure>
    <time_frame>Up to Week 12</time_frame>
    <description>An examination was performed to assess injection site tolerability at every posttreatment visit from Week 1 to Week 12 (end of core phase).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>World Health Organization (WHO) Performance Status</measure>
    <time_frame>Up to Week 12</time_frame>
    <description>WHO performance status was monitored up to Week 12 to compare final status with baseline status.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diptheria Toxoid Antibody Levels</measure>
    <time_frame>Up to Week 12</time_frame>
    <description>Diptheria toxoid antibody levels were measured at screening and at Week 12 to assess toxicity from Diptheria toxoid.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>Up to Week 24</time_frame>
    <description>Any adverse events that were reported during the study</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Gastric Cancer</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>G17DT; 250 µg dose administered at 0, 1, and 3 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>G17DT; 100 µg dose administered at 0, 1, and 3 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>G17DT; 500 µg dose administered at 0, 1, and 3 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>G17DT; 500 µg dose administered at 0, 2, and 6 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>G17DT</intervention_name>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_label>Group 3</arm_group_label>
    <arm_group_label>Group 4</arm_group_label>
    <other_name>Polyclonal Antibody Stimulator (PAS)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed UICC Stage I, II or III gastric adenocarcinoma. Must have had&#xD;
             a macroscopically curative resection for gastric cancer with absence of metastatic&#xD;
             disease at the time of entry to the trial&#xD;
&#xD;
          -  Male or female and over 18 years of age&#xD;
&#xD;
          -  Must have a life expectancy of at least three months&#xD;
&#xD;
          -  World Health Organization Performance Status of 0 to 1&#xD;
&#xD;
          -  Given written conformed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Gastric surgery within four weeks of baseline (week 0) or gastric surgery anticipated&#xD;
             in the period of the study&#xD;
&#xD;
          -  History of other malignant disease within the previous five years, except&#xD;
             non-melanomatous skin cancer or in situ carcinoma of the uterine cervix&#xD;
&#xD;
          -  Previous use within the last four weeks, concomitant use or anticipated use in the&#xD;
             period of the study, of any anti-cancer therapies&#xD;
&#xD;
          -  Concomitant use of immunosuppressants, including systemic (i.e. oral or injected)&#xD;
             corticosteroids&#xD;
&#xD;
          -  Females who pregnant, planning to become pregnant or lactating&#xD;
&#xD;
          -  Taking part in another study involving an investigational or licensed drug or device&#xD;
             in the three months preceding enrollment or during this study&#xD;
&#xD;
          -  Previously received G17DT treatment&#xD;
&#xD;
          -  Haemoglobin (Hb) &lt; 10.0 g/dL White blood cell count (WBC) &lt; 4.0 x 10^9/L Platelets &lt;&#xD;
             100 x 10^9/L&#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>Peter G McCulloch, MB, ChB</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Aintree</affiliation>
  </overall_official>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>August 27, 2014</study_first_submitted>
  <study_first_submitted_qc>September 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 8, 2014</study_first_posted>
  <last_update_submitted>September 5, 2014</last_update_submitted>
  <last_update_submitted_qc>September 5, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 8, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>gastric cancer, stomach neoplasms,</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stomach Neoplasms</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02233712
org study id: GC3
nct id: NCT02233712
lead sponsor: 
has dmc: Yes
An open label, dose-finding, schedule-changing, sequential, multiple dose, multi-center study
      in patients with Stage I-III gastric cancer. The first group of patients received a starting
      dose of 250 µg at weeks 0, 1, and 3. Thereafter, allocation to treatment with 100 µg or 500
      µg was based on antibody response and dose tolerability.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Antibody Levels
time frame: Up to Week 24
description: Gastrin-17 antibodies are produced as a result of treatment with G17DT and the proportion of patients producing gastrin-17 antibodies was considered to be an appropriate measure of the immunogenicity of the dosing schedule under study.
measure: Injection Site Reaction
time frame: Up to Week 12
description: An examination was performed to assess injection site tolerability at every posttreatment visit from Week 1 to Week 12 (end of core phase).
measure: World Health Organization (WHO) Performance Status
time frame: Up to Week 12
description: WHO performance status was monitored up to Week 12 to compare final status with baseline status.
measure: Diptheria Toxoid Antibody Levels
time frame: Up to Week 12
description: Diptheria toxoid antibody levels were measured at screening and at Week 12 to assess toxicity from Diptheria toxoid.
measure: Adverse Events
time frame: Up to Week 24
description: Any adverse events that were reported during the study
arm group label: Group 1
arm group type: Experimental
description: G17DT; 250 µg dose administered at 0, 1, and 3 weeks.
arm group label: Group 2
arm group type: Experimental
description: G17DT; 100 µg dose administered at 0, 1, and 3 weeks.
arm group label: Group 3
arm group type: Experimental
description: G17DT; 500 µg dose administered at 0, 1, and 3 weeks.
arm group label: Group 4
arm group type: Experimental
description: G17DT; 500 µg dose administered at 0, 2, and 6 weeks.
intervention type: Biological
intervention name: G17DT
arm group label: Group 1
arm group label: Group 2
arm group label: Group 3
arm group label: Group 4
other name: Polyclonal Antibody Stimulator (PAS)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Peter G McCulloch, MB, ChB
role: Principal Investigator
affiliation: University Hospital Aintree
responsible party type: Sponsor
mesh term: Stomach Neoplasms