<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/NCT02228785</url>
  </required_header>
  <id_info>
    <org_study_id>CC1C</org_study_id>
    <nct_id>NCT02228785</nct_id>
  </id_info>
  <brief_title>A Study of the Safety and Tolerance of Three Doses of G17DT in Metastatic Colorectal Cancer</brief_title>
  <acronym>CC1C</acronym>
  <official_title>Study of the Safety and Tolerance of Three Doses of G17DT in Patients With Metastatic Colorectal 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>
      This study was designed to investigate the safety and tolerance of three doses (100µg, 200µg,&#xD;
      500µg) of G17DT for the treatment of patients with colorectal cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Poor local tolerance to injection.&#xD;
  </why_stopped>
  <start_date>May 1994</start_date>
  <primary_completion_date type="Actual">October 1994</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Injection Site Reaction</measure>
    <time_frame>Through Week 12</time_frame>
    <description>An examination was performed to assess injection site tolerability at every posttreatment visit.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Antibody Levels</measure>
    <time_frame>Through Week 12</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>
  <secondary_outcome>
    <measure>Intra-gastric pH</measure>
    <time_frame>Through Week 8</time_frame>
    <description>Compare the pre-immunization 24-hour intra-gastric pH with post-immunization profiles.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>100µg dose of G17DT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this arm received a 100µg dose of G17DT via intramuscular injection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>200µg dose of G17DT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this arm received a 200 µg dose of G17DT via intramuscular injection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>500µg dose of G17DT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this arm received a 500µg dose of G17DT via intramuscular injection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>G17DT</intervention_name>
    <arm_group_label>100µg dose of G17DT</arm_group_label>
    <arm_group_label>200µg dose of G17DT</arm_group_label>
    <arm_group_label>500µg dose of G17DT</arm_group_label>
    <other_name>Polyclonal Antibody Stimulator</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged 18 years or over with histologically verified adenocarcinoma of colon or&#xD;
             rectum.&#xD;
&#xD;
          -  Recurrent of metastatic disease not amenable to curative surgery and/or radiotherapy.&#xD;
&#xD;
          -  Life expectancy greater than 3 months.&#xD;
&#xD;
          -  Karnofsky Index Score greater than or equal to 50%.&#xD;
&#xD;
          -  Written informed consent obtained.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Neoplastic lesions other than colorectal cancer (except treated basal cell carcinoma&#xD;
             of the skin or cancer of the uterine cervix, through Stage I.&#xD;
&#xD;
          -  Acute intercurrent illness.&#xD;
&#xD;
          -  Patient considered to be a medical risk because of non-malignant systemic disease or&#xD;
             grossly abnormal laboratory results.&#xD;
&#xD;
          -  Patients who had received any other anticancer therapy within 3 months.&#xD;
&#xD;
          -  Factor liable to alter the serum gastrin concentration or affect intra-gastric&#xD;
             acidity, for instance concomitant therapy with H2 receptor antagonist drugs, proton&#xD;
             pump inhibitors, or previous gastric surgery.&#xD;
&#xD;
          -  Patients immunologically compromised including those on corticosteroid therapy.&#xD;
&#xD;
          -  Women of child-bearing age.&#xD;
&#xD;
          -  Positive immediate hypersensitivity reaction to skin testing with study medication.&#xD;
&#xD;
          -  Patients unable to complete the diary book&#xD;
&#xD;
          -  Haematogical Status Haemoglobin count less than 10g/dL White Blood Cell count less&#xD;
             than 4.0 x 10^9/L Platelet count less than 100 x 10^9/L&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>J D Hardcastle, MChir, FRCP, FRCS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Nottingham</affiliation>
  </overall_official>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 27, 2014</study_first_submitted>
  <study_first_submitted_qc>August 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2014</study_first_posted>
  <last_update_submitted>August 28, 2014</last_update_submitted>
  <last_update_submitted_qc>August 28, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 29, 2014</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>Colorectal 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/NCT02228785
org study id: CC1C
nct id: NCT02228785
lead sponsor: 
has dmc: Yes
This study was designed to investigate the safety and tolerance of three doses (100µg, 200µg,
      500µg) of G17DT for the treatment of patients with colorectal cancer.
allocation: Randomized
primary purpose: Treatment
masking: None (Open Label)
measure: Injection Site Reaction
time frame: Through Week 12
description: An examination was performed to assess injection site tolerability at every posttreatment visit.
measure: Antibody Levels
time frame: Through Week 12
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: Intra-gastric pH
time frame: Through Week 8
description: Compare the pre-immunization 24-hour intra-gastric pH with post-immunization profiles.
arm group label: 100µg dose of G17DT
arm group type: Experimental
description: Patients in this arm received a 100µg dose of G17DT via intramuscular injection.
arm group label: 200µg dose of G17DT
arm group type: Experimental
description: Patients in this arm received a 200 µg dose of G17DT via intramuscular injection.
arm group label: 500µg dose of G17DT
arm group type: Experimental
description: Patients in this arm received a 500µg dose of G17DT via intramuscular injection.
intervention type: Biological
intervention name: G17DT
arm group label: 100µg dose of G17DT
arm group label: 200µg dose of G17DT
arm group label: 500µg dose of G17DT
other name: Polyclonal Antibody Stimulator
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: J D Hardcastle, MChir, FRCP, FRCS
role: Principal Investigator
affiliation: University of Nottingham
responsible party type: Sponsor
mesh term: Colorectal Neoplasms