Gastric CancerPhase 2GC3NCT02233712
Open-label, Dose-finding Study to Determine Antibody Response to G17DT Treatment in Patients With Gastric Cancer.
A Phase 2 study testing G17DT in people with Gastric Cancer, run by Cancer Advances Inc..
Trial summary
An open label, dose-finding, schedule-changing, sequential, multiple dose, multi-center study in patients with Stage I-III gastric cancer. The first group of patients received a starting dose of 250 µg at weeks 0, 1, and 3. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- G17DT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- Aug 1999to Mar 2000
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed UICC Stage I, II or III gastric adenocarcinoma. Must have had a macroscopically curative resection for gastric cancer with absence of metastatic disease at the time of entry to the trial
- Male or female and over 18 years of age
- Must have a life expectancy of at least three months
- World Health Organization Performance Status of 0 to 1
- Given written conformed consent
Who cannot join
- Gastric surgery within four weeks of baseline (week 0) or gastric surgery anticipated in the period of the study
- 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 last four weeks, concomitant use or anticipated use in the period of the study, of any anti-cancer therapies
- Concomitant use of immunosuppressants, including systemic (i.e. oral or injected) corticosteroids
- Females who pregnant, planning to become pregnant or lactating
- Taking part in another study involving an investigational or licensed drug or device in the three months preceding enrollment or during this study
- Previously received G17DT treatment
- Haemoglobin (Hb) < 10.0 g/dL White blood cell count (WBC) < 4.0 x 10^9/L Platelets < 100 x 10^9/L
About this study
Official title: An Open-label, Dose-finding, Schedule-changing, Multi-center Study to Determine the Antibody Response to G17DT Treatment of Patients With Gastric Cancer.
An open label, dose-finding, schedule-changing, sequential, multiple dose, multi-center study in patients with Stage I-III gastric cancer. The first group of patients received a starting dose of 250 µg at weeks 0, 1, and 3. Thereafter, allocation to treatment with 100 µg or 500 µg was based on antibody response and dose tolerability.
- Conditions
- Gastric Cancer
- Being tested
- G17DT
- Keywords
- gastric cancer, stomach neoplasms,
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G17DTBiological
Also called Polyclonal Antibody Stimulator (PAS)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | G17DT; 250 µg dose administered at 0, 1, and 3 weeks. Receives: Biological: G17DT |
| Group 2 | Experimental | G17DT; 100 µg dose administered at 0, 1, and 3 weeks. Receives: Biological: G17DT |
| Group 3 | Experimental | G17DT; 500 µg dose administered at 0, 1, and 3 weeks. Receives: Biological: G17DT |
| Group 4 | Experimental | G17DT; 500 µg dose administered at 0, 2, and 6 weeks. Receives: Biological: G17DT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody Levels
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.
Measured: Up to Week 24
Injection Site Reaction
An examination was performed to assess injection site tolerability at every posttreatment visit from Week 1 to Week 12 (end of core phase).
Measured: Up to Week 12
World Health Organization (WHO) Performance Status
WHO performance status was monitored up to Week 12 to compare final status with baseline status.
Measured: Up to Week 12
Diptheria Toxoid Antibody Levels
Diptheria toxoid antibody levels were measured at screening and at Week 12 to assess toxicity from Diptheria toxoid.
Measured: Up to Week 12
Secondary outcomes (1)
Adverse Events
Any adverse events that were reported during the study
Measured: Up to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2014 (estimated)
- Study startAug 1999
- Primary completionMar 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cancer Advances Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter G McCulloch, MB, ChB, Principal investigator, University Hospital Aintree
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02233712
- Sponsor's protocol ID
- GC3
- Acronym
- GC3
- Status last verified
- Sep 2014
- First submitted
- 27 Aug 2014
- Last updated
- 8 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Dose-finding, Schedule-changing, Multi-center Study to Determine the Antibody Response to G17DT Treatment of Patients With Gastric Cancer.
- ClinicalTrials.gov ID
- NCT02233712
- Acronym / sponsor ID
- GC3 / GC3
- Conditions
- Gastric Cancer
- Keywords
- gastric cancer, stomach neoplasms,
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Cancer Advances Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 1999
- Primary completion
- Mar 2000 (actual)
- First posted
- 8 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open label, dose-finding, schedule-changing, sequential, multiple dose, multi-center study in patients with Stage I-III gastric cancer. The first group of patients received a starting dose of 250 µg at weeks 0, 1, and 3. Thereafter, allocation to treatment with 100 µg or 500 µg was based on antibody response and dose tolerability.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: G17DTG17DT; 250 µg dose administered at 0, 1, and 3 weeks. |
| Group 2 | Experimental | Biological: G17DTG17DT; 100 µg dose administered at 0, 1, and 3 weeks. |
| Group 3 | Experimental | Biological: G17DTG17DT; 500 µg dose administered at 0, 1, and 3 weeks. |
| Group 4 | Experimental | Biological: G17DTG17DT; 500 µg dose administered at 0, 2, and 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically confirmed UICC Stage I, II or III gastric adenocarcinoma. Must have had a macroscopically curative resection for gastric cancer with absence of metastatic disease at the time of entry to the trial
- Male or female and over 18 years of age
- Must have a life expectancy of at least three months
- World Health Organization Performance Status of 0 to 1
- Given written conformed consent
Key exclusion criteria (8 listed)
- Gastric surgery within four weeks of baseline (week 0) or gastric surgery anticipated in the period of the study
- 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 last four weeks, concomitant use or anticipated use in the period of the study, of any anti-cancer therapies
- Concomitant use of immunosuppressants, including systemic (i.e. oral or injected) corticosteroids
- Females who pregnant, planning to become pregnant or lactating
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| G17DTAlso: Polyclonal Antibody Stimulator (PAS) | Biological | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
Antibody Levels
Time frame: Up to Week 24
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.
Injection Site Reaction
Time frame: Up to Week 12
An examination was performed to assess injection site tolerability at every posttreatment visit from Week 1 to Week 12 (end of core phase).
World Health Organization (WHO) Performance Status
Time frame: Up to Week 12
WHO performance status was monitored up to Week 12 to compare final status with baseline status.
Diptheria Toxoid Antibody Levels
Time frame: Up to Week 12
Diptheria toxoid antibody levels were measured at screening and at Week 12 to assess toxicity from Diptheria toxoid.
1 secondary outcome
Adverse Events
Time frame: Up to Week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter G McCulloch, MB, ChB principal investigator
University Hospital Aintree
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing G17DT in people with Gastric Cancer, run by Cancer Advances Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibody Levels (time frame: Up to Week 24). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2014; AzTrials last refreshed its copy on 3 Nov 2026.