search
Back to results

Study to Assess Tolerability and Safety and Antibody Response to G17DT in Gastric Cancer Patients

Primary Purpose

Gastric Cancer

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
G17DT
Sponsored by
Cancer Advances Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients who had had curative resection for histologically confirmed Stage I, II, or III gastric carcinoma or carcinoma of the oesophagogastric junciton.
  • Male or female patients over 18 years of age.
  • Patients with a life expectancy of at least four months.
  • Karnofsky index for performance status of >70%
  • Patients must have given written informed consent.

Exclusion Criteria:

  • Gastric or junctional surgery within three weeks of baseline (week 0) or gastric or junctional surgery anticipated in the study period.
  • History of other malignant disease within the previous five years, except non-melanomatous skin cancer or in situ carcinoma of the uterine cervix.
  • Previous use (within the six weeks prior to the screening visit of the study), concomitant use, or anticipated use (up to week 16), of chemotherapy or immunotherapy.
  • Previous use (within the six weeks prior to the screening visit of the study), concomitant use, or anticipated use (up to week 16), of radiotherapy or any other anti-cancer therapy.
  • Previous use (within the four weeks prior to the screening visit of the study), concomitant use, or anticipated use (up to week 16), of immunosuppressants, including systemic corticosteroids.
  • Known immunodeficiency.
  • Females who were pregnant, planning to become pregnant or lactating. Women, who in the opinion of the investigator were of child bearing potential, were to have a negative pregnancy test before study drug administration.
  • Patients taking part in another study involving an investigational or licensed drug or device in the three months preceding enrolment or up to week 16 during this study.
  • Previous G17DT treatment.
  • Haematological indicators:

Haemoglobin <10.0g/dl Neutrophils < 2.0 x 109/l Platelets <100 x 109/l

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    250µg dose treatment

    Arm Description

    Subjects were treated with a 250mcg/0.2ml G17DT injection at weeks 0, 2 and 6.

    Outcomes

    Primary Outcome Measures

    Measurable Gastrin-17 Antibody Titer

    Secondary Outcome Measures

    Injection tolerability
    Subjects were monitored for injection site reactions and/or swelling at the injections site.
    Overall Survival from date of randomization to death or end of study

    Full Information

    First Posted
    August 4, 2015
    Last Updated
    August 5, 2015
    Sponsor
    Cancer Advances Inc.
    Collaborators
    PPD, ChapelPharma Ltd
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02518529
    Brief Title
    Study to Assess Tolerability and Safety and Antibody Response to G17DT in Gastric Cancer Patients
    Official Title
    An Open, Multi-centre Study to Determine the Tolerability, Safety and Antibody Response Resulting From G17DT at 250mcg at Weeks 0, 2 and 6 With a Booster of 125mcg or 250mcg Given to Patients With Stage I - III Gastric Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2001 (undefined)
    Primary Completion Date
    December 2002 (Actual)
    Study Completion Date
    December 2002 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Cancer Advances Inc.
    Collaborators
    PPD, ChapelPharma Ltd

    4. Oversight

    5. Study Description

    Brief Summary
    Open-label, multicenter study to assess 250µg/0.2ml G17DT injection at weeks 0, 2 and 6. At or after week 20 and up to and including week 44. Subjects who raised antibodies to G17DT were given an additional dose of 125µg/0.1ml or 250µg/0.2ml G17DT between weeks 20-44 (study duration 52 weeks).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastric Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    41 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    250µg dose treatment
    Arm Type
    Experimental
    Arm Description
    Subjects were treated with a 250mcg/0.2ml G17DT injection at weeks 0, 2 and 6.
    Intervention Type
    Biological
    Intervention Name(s)
    G17DT
    Other Intervention Name(s)
    Gastrimmune, Insegia, PAS
    Primary Outcome Measure Information:
    Title
    Measurable Gastrin-17 Antibody Titer
    Time Frame
    Up to Week 52
    Secondary Outcome Measure Information:
    Title
    Injection tolerability
    Description
    Subjects were monitored for injection site reactions and/or swelling at the injections site.
    Time Frame
    Up to Week 52
    Title
    Overall Survival from date of randomization to death or end of study
    Time Frame
    Up to December 2002

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients who had had curative resection for histologically confirmed Stage I, II, or III gastric carcinoma or carcinoma of the oesophagogastric junciton. Male or female patients over 18 years of age. Patients with a life expectancy of at least four months. Karnofsky index for performance status of >70% Patients must have given written informed consent. Exclusion Criteria: Gastric or junctional surgery within three weeks of baseline (week 0) or gastric or junctional surgery anticipated in the study period. History of other malignant disease within the previous five years, except non-melanomatous skin cancer or in situ carcinoma of the uterine cervix. Previous use (within the six weeks prior to the screening visit of the study), concomitant use, or anticipated use (up to week 16), of chemotherapy or immunotherapy. Previous use (within the six weeks prior to the screening visit of the study), concomitant use, or anticipated use (up to week 16), of radiotherapy or any other anti-cancer therapy. Previous use (within the four weeks prior to the screening visit of the study), concomitant use, or anticipated use (up to week 16), of immunosuppressants, including systemic corticosteroids. Known immunodeficiency. Females who were pregnant, planning to become pregnant or lactating. Women, who in the opinion of the investigator were of child bearing potential, were to have a negative pregnancy test before study drug administration. Patients taking part in another study involving an investigational or licensed drug or device in the three months preceding enrolment or up to week 16 during this study. Previous G17DT treatment. Haematological indicators: Haemoglobin <10.0g/dl Neutrophils < 2.0 x 109/l Platelets <100 x 109/l

    12. IPD Sharing Statement

    Learn more about this trial

    Study to Assess Tolerability and Safety and Antibody Response to G17DT in Gastric Cancer Patients

    We'll reach out to this number within 24 hrs