Gastric CancerPhase 2NCT02521649
Dose-ranging Study to Evaluate Antibody Response to G17DT 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, dose-ranging, multiple dose, multi-centre study in patients with Stage I-III or Stage IV gastric cancer. Twelve patients in each of 5 treatment groups were to receive three injections at weeks 0, 2 and 6 with provision for a single booster injection in an extension study period. Read more about this study
- Who is it for?
- Any age
- 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
- 52 participants
- Where
- No sites listed yet
- Study dates
- Sep 1998to Jan 2001
- 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 Any age
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Stage I-III Criteria-
- Patients aged 18 years or over who had had a macroscopically curative resection for gastric adenocarcinoma.
- Absence of metastatic disease evident from:
- physical examination
- the most recent chest X-ray
- abdominal CT or ultrasound scan
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- Life expectancy of at least 3 months
- WHO performance status of 0 to 1
- Written informed consent given
- Stage IV Criteria-
- Patients aged 18 years or over with Stage IV gastric cancer: carcinoma with the primary tumour invading the adjacent structures and/or involvement of more than 15 regional lymph nodes and/or distant metastases
- Life expectancy of at least 3 months
- WHO performance status of 0 to 2
- Written informed consent given
Who cannot join
- History of other malignant disease except non-melanomatous skin cancer or in situ carcinoma of the uterine cervix Recurrent gastric cancer following previous surgery Presence of metastatic disease: peritoneal deposits or involved lymph nodes outside the limit of resection
- Previous use, concomitant use or anticipated use in the period of the study, of any anti-cancer therapies
- Concomitant use of immunosuppressants, including systemic (ie oral or injected) corticosteroids
- Females who were pregnant, planning to become pregnant or lactating
- Patients who were taking part in another study involving an investigational or licensed drug or device in the three months preceding enrolment or during this study
- Previous G17DT treatment
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- Haematological indicators:
- Haemoglobin <10.0g/dl
- White blood cell count <4.0 x 109/l
- Platelets <100 x 109/l
About this study
Official title: An Open, Dose-ranging, Multicenter Study to Determine the Antibody Response to G17DT and Its Safety and Tolerability in the Treatment of Patients With Gastric Cancer
An open, dose-ranging, multiple dose, multi-centre study in patients with Stage I-III or Stage IV gastric cancer. Twelve patients in each of 5 treatment groups were to receive three injections at weeks 0, 2 and 6 with provision for a single booster injection in an extension study period.
- Conditions
- Gastric Cancer
- Being tested
- G17DT
- Keywords
- Gastric Cancer, G17DT, PAS, Insegia, Gastrimmune
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G17DTDrug
Also called Gastrimmune, Insegia, PAS
| Study group | Role | What they receive |
|---|---|---|
| 10µg, Stage I-III | Experimental | 10µg/0.2 mL dose of G17DT administered at Weeks 0,2, and 6 with an option of a 125µg/0.1 mL dose of G17DT administered at Week 12 based on measured antibody titer. Receives: Drug: G17DT |
| 100µg, Stage I-III | Experimental | 100µg/0.2 mL dose of G17DT administered at Weeks 0,2, and 6 with an option of a 125µg/0.1 mL dose of G17DT administered at Week 12 based on measured antibody titer. Receives: Drug: G17DT |
| 250µg, Stage I-III | Experimental | 250µg/0.2 mL dose of G17DT administered at Weeks 0,2, and 6 with an option of a 125µg/0.1 mL dose of G17DT administered at Week 12 based on measured antibody titer. Receives: Drug: G17DT |
| 100µg, Stage IV | Experimental | 100µg/0.2 mL dose of G17DT administered at Weeks 0,2, and 6 with an option of a 125µg/0.1 mL dose of G17DT administered at Week 12 based on measured antibody titer. Receives: Drug: G17DT |
| 250µg, Stage IV | Experimental | 250µg/0.2 mL dose of G17DT administered at Weeks 0,2, and 6 with an option of a 125µg/0.1 mL dose of G17DT administered at Week 12 based on measured antibody titer. Receives: Drug: G17DT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurable Antibody Titer
Measured: Up to Week 12
Secondary outcomes (2)
Overall Survival from date of randomization to death or end of study
Patients were scheduled to attend follow-up visits every four weeks after completion of the 12-week core period of the study and to continue until the patient was discharged from the study or declined further follow-up.
Measured: Up to Last Patient Last Visit, January 2001
Injection Site Reaction
A physical examination for the presence of an abcess at the injection site was performed on each patient to assess tolerability to treatment at every posttreatment visit from Week 0 to Week 12.
Measured: Through Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startSep 1998
- Primary completionJan 2001
- Study completionJan 2001
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cancer Advances Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinical Project Services, MPS Research Unit
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02521649
- Sponsor's protocol ID
- GC2
- Status last verified
- Aug 2015
- First submitted
- 15 May 2015
- Last updated
- 13 Aug 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Dose-ranging, Multicenter Study to Determine the Antibody Response to G17DT and Its Safety and Tolerability in the Treatment of Patients With Gastric Cancer
- ClinicalTrials.gov ID
- NCT02521649
- Acronym / sponsor ID
- GC2
- Conditions
- Gastric Cancer
- Keywords
- Gastric Cancer, G17DT, PAS, Insegia, Gastrimmune
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Cancer Advances Inc.Industry (pharma, biotech, devices)
- Collaborators
- Clinical Project Services, MPS Research Unit
- Study start
- Sep 1998
- Primary completion
- Jan 2001 (actual)
- Study completion
- Jan 2001 (actual)
- First posted
- 13 Aug 2015 (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, dose-ranging, multiple dose, multi-centre study in patients with Stage I-III or Stage IV gastric cancer. Twelve patients in each of 5 treatment groups were to receive three injections at weeks 0, 2 and 6 with provision for a single booster injection in an extension study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 10µg, Stage I-III | Experimental | Drug: G17DT10µg/0.2 mL dose of G17DT administered at Weeks 0,2, and 6 with an option of a 125µg/0.1 mL dose of G17DT administered at Week 12 based on measured antibody titer. |
| 100µg, Stage I-III | Experimental | Drug: G17DT100µg/0.2 mL dose of G17DT administered at Weeks 0,2, and 6 with an option of a 125µg/0.1 mL dose of G17DT administered at Week 12 based on measured antibody titer. |
| 250µg, Stage I-III | Experimental | Drug: G17DT250µg/0.2 mL dose of G17DT administered at Weeks 0,2, and 6 with an option of a 125µg/0.1 mL dose of G17DT administered at Week 12 based on measured antibody titer. |
| 100µg, Stage IV | Experimental | Drug: G17DT100µg/0.2 mL dose of G17DT administered at Weeks 0,2, and 6 with an option of a 125µg/0.1 mL dose of G17DT administered at Week 12 based on measured antibody titer. |
| 250µg, Stage IV | Experimental | Drug: G17DT250µg/0.2 mL dose of G17DT administered at Weeks 0,2, and 6 with an option of a 125µg/0.1 mL dose of G17DT administered at Week 12 based on measured antibody titer. |
Who may qualify
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- Stage I-III Criteria-
- Patients aged 18 years or over who had had a macroscopically curative resection for gastric adenocarcinoma.
- Absence of metastatic disease evident from:
- Life expectancy of at least 3 months
- WHO performance status of 0 to 1
Key exclusion criteria (10 listed)
- History of other malignant disease except non-melanomatous skin cancer or in situ carcinoma of the uterine cervix Recurrent gastric cancer following previous surgery Presence of metastatic disease: peritoneal deposits or involved lymph nodes outside the limit of resection
- Previous use, concomitant use or anticipated use in the period of the study, of any anti-cancer therapies
- Concomitant use of immunosuppressants, including systemic (ie oral or injected) corticosteroids
- Females who were pregnant, planning to become pregnant or lactating
- Patients who were taking part in another study involving an investigational or licensed drug or device in the three months preceding enrolment or during this study
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: Gastrimmune, Insegia, PAS | Drug | 100µg, Stage I-III, 100µg, Stage IV, 10µg, Stage I-III, 250µg, Stage I-III, 250µg, Stage IV |
Primary outcome
Measurable Antibody Titer
Time frame: Up to Week 12
2 secondary outcomes
Overall Survival from date of randomization to death or end of study
Time frame: Up to Last Patient Last Visit, January 2001
Injection Site Reaction
Time frame: Through Week 12
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 13 Aug 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 14 inclusion and 10 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 13 Aug 2015. 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?
Measurable Antibody Titer (time frame: Up to Week 12). 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 13 Aug 2015.