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

August 5, 2015 updated by: Cancer Advances Inc.

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 250µg dose treatment
Subjects were treated with a 250mcg/0.2ml G17DT injection at weeks 0, 2 and 6.
Biological: G17DT
Other Names:
  • Gastrimmune, Insegia, PAS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measurable Gastrin-17 Antibody Titer
Time Frame: Up to Week 52
Up to Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Injection tolerability
Time Frame: Up to Week 52
Subjects were monitored for injection site reactions and/or swelling at the injections site.
Up to Week 52
Overall Survival from date of randomization to death or end of study
Time Frame: Up to December 2002
Up to December 2002

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Advances Inc.

Collaborators

PPD
ChapelPharma Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2001

Primary Completion (Actual)

December 1, 2002

Study Completion (Actual)

December 1, 2002

Study Registration Dates

First Submitted

August 4, 2015

First Submitted That Met QC Criteria

August 5, 2015

First Posted (Estimate)

August 10, 2015

Study Record Updates

Last Update Posted (Estimate)

August 10, 2015

Last Update Submitted That Met QC Criteria

August 5, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GC12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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