<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/NCT02223078</url>
  </required_header>
  <id_info>
    <org_study_id>CC4</org_study_id>
    <nct_id>NCT02223078</nct_id>
  </id_info>
  <brief_title>Two Center Study to Determine Effect of G17DT on Plasma Gastrin Levels in Patients With Colorectal Cancer.</brief_title>
  <acronym>CC4</acronym>
  <official_title>Phase II, Randomised, Double-blind, Placebo-controlled, Parallel Group, Two Centre Study to Determine the Effect of G17DT on Plasma Gastrin Levels in Patients With 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>
  <brief_summary>
    <textblock>
      Pancreatic, gastric, and colorectal cancers have all been shown to overexpress the gastrin&#xD;
      gene and to be sensitive to the trophic effects of the gastrin in animal models. The&#xD;
      hypothesis of this study is that G17DT will elicit specific and high-affinity antibodies that&#xD;
      will bind gastrin-17, thus preventing the trophic activity of cancer cells.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2000</start_date>
  <completion_date type="Actual">November 2001</completion_date>
  <primary_completion_date type="Actual">August 2001</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Antibody Levels</measure>
    <time_frame>12 weeks</time_frame>
    <description>Assess effects of gastrin-17 antibodies in response to G17DT immunization.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>pharmacodynamic</measure>
    <time_frame>12 weeks</time_frame>
    <description>measure production of gastrin-17 antibodies.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Serious and Non-Serious Adverse Events</measure>
    <time_frame>12 weeks</time_frame>
    <description>Adverse events, defined as any event involving adverse reactions, illnesses with onset during the study, or exacerbations of pre-existing illnesses, were assessed at each visit.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>G17DT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Three 250 µg injections over a six week period (weeks 0,2 and 6)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Three 250 µg injections of a placebo over a six week period (weeks 0,2 and 6)</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>G17DT</intervention_name>
    <arm_group_label>G17DT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo Comparator</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with histologically confirmed colorectal carcinoma for whom no other&#xD;
             anti-cancer treatment was anticipated during the three month period of study.&#xD;
&#xD;
          -  Patients taking a proton pump inhibitor at a fixed daily dose which had remained&#xD;
             unchanged for at least six weeks preceding screening and was not anticipated to change&#xD;
             during the study.&#xD;
&#xD;
          -  Proton pump inhibitor compliance of ~70% (to be measured between screening and&#xD;
             baseline (week 0)).&#xD;
&#xD;
          -  Male or female patients from 18 to 65 years of age.&#xD;
&#xD;
          -  Patients with a life expectancy of over three months.&#xD;
&#xD;
          -  World Health Organisation (WHO) Performance Status of 0 to 1.&#xD;
&#xD;
          -  Written informed consent given.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients in receipt of histamine H2-receptor (H2 receptor) antagonists or any other&#xD;
             antacid therapy, other than a proton pump inhibitor at a stable dose.&#xD;
&#xD;
          -  Patients with any other factor likely to alter intra-gastric acidity e.g. previous&#xD;
             gastric surgery, including vagotomy or anatomically abnormal upper gastrointestinal&#xD;
             tract.&#xD;
&#xD;
          -  History of other malignant disease within the previous five years, except non-&#xD;
             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 radiotherapy or chemotherapy.&#xD;
&#xD;
          -  Concomitant use of immunosuppressants, including systemic (i .e. oral or injected)&#xD;
             corticosteroids.&#xD;
&#xD;
          -  Females who were pregnant, planning to become pregnant or lactating. Women, who in the&#xD;
             opinion of the investigator were of child bearing potential, were to have a negative&#xD;
             pregnancy test before study drug administration.&#xD;
&#xD;
          -  Patients taking part in another study involving an investigational or licensed drug or&#xD;
             device in the three months preceding enrolment or during the study.&#xD;
&#xD;
          -  Previous G 17DT treatment.&#xD;
&#xD;
          -  Haematological indicators:&#xD;
&#xD;
        Haemoglobin &lt;10.0 g/dL White blood cell count &lt;4.0 x 109/L Platelets &lt; 100 x 1 09/L&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University Hospital Aintree</name>
      <address>
        <city>Liverpool</city>
        <state>Merseyside</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>July 2, 2014</study_first_submitted>
  <study_first_submitted_qc>August 20, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2014</study_first_posted>
  <last_update_submitted>June 19, 2017</last_update_submitted>
  <last_update_submitted_qc>June 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 20, 2017</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/NCT02223078
org study id: CC4
nct id: NCT02223078
lead sponsor: 
Pancreatic, gastric, and colorectal cancers have all been shown to overexpress the gastrin
      gene and to be sensitive to the trophic effects of the gastrin in animal models. The
      hypothesis of this study is that G17DT will elicit specific and high-affinity antibodies that
      will bind gastrin-17, thus preventing the trophic activity of cancer cells.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Antibody Levels
time frame: 12 weeks
description: Assess effects of gastrin-17 antibodies in response to G17DT immunization.
measure: pharmacodynamic
time frame: 12 weeks
description: measure production of gastrin-17 antibodies.
measure: Number of Participants with Serious and Non-Serious Adverse Events
time frame: 12 weeks
description: Adverse events, defined as any event involving adverse reactions, illnesses with onset during the study, or exacerbations of pre-existing illnesses, were assessed at each visit.
arm group label: G17DT
arm group type: Experimental
description: Three 250 µg injections over a six week period (weeks 0,2 and 6)
arm group label: Placebo
arm group type: Placebo Comparator
description: Three 250 µg injections of a placebo over a six week period (weeks 0,2 and 6)
intervention type: Biological
intervention name: G17DT
arm group label: G17DT
intervention type: Biological
intervention name: Placebo Comparator
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Colorectal Neoplasms