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
About this trial
This is an interventional treatment trial for Gastric Cancer
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
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
NCT ID
NCT02518529
First Posted
August 4, 2015
Last Updated
August 5, 2015
Sponsor
Cancer Advances Inc.
Collaborators
PPD, ChapelPharma Ltd
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
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