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| Name | Class |
|---|---|
| Clinical Project Services | UNKNOWN |
| MPS Research Unit | UNKNOWN |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| G17DT | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measurable Antibody Titer | Up to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to Last Patient Last Visit, January 2001 |
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Inclusion Criteria:
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
Written informed consent given
Stage IV Criteria-
Exclusion Criteria:
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
Haematological indicators:
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C482698 | gastrin immunogen |
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|
| 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. |
| Through Week 12 |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |