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Compare the effect of G17DT with that of placebo on the survival of subjects with advanced pancreatic cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| G17DT | Experimental | 250 µg administered at Weeks 0,1,3 and 24 by intramuscular injection, followed by additional injections (boosters) of 250 µg every 6 months at investigator's discretion. |
|
| Placebo | Placebo Comparator | Placebo administered at Weeks 0, 1, 3, and 24 by intramuscular injection followed by additonal injections of placebo every 6 months. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| G17DT | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Survival | The vital status of each patient was followed until death or end of the study. | Up to week 134 |
| Number of Participants with Serious and Non-Serious Adverse Events | Adverse events, defined as any event involving adverse reactions, illnesses with onset during the study, or exacerbations of pre-exisiting illnesses, were assessed at each visit. | up to week 134 |
| Measure | Description | Time Frame |
|---|---|---|
| Objective tumor response | Patients were monitored for an objective tumor response measured by means of an abdomincal computed tomography. | Weeks 24 and 52 |
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Inclusion Criteria:
Exclusion Criteria:
Previous, concomitant, or anticipated use (up to Week 12) of chemotherapy, radiotherapy, immunotherapy, or any other anticancer therapy
Previous (during the 4 weeks before the study), concomitant, or anticipated use (up to Week 12) of immunosuppressants. However, for systemic [i.e., oral or injected] corticosteroids, previous use and concomitant use at study entry were prohibited, while introduction during the course of the study was permitted.)
History of other malignant tumor within the previous 5 years, except nonmelanomatous skin cancer, and in situ carcinoma of the uterine cervix
Known immunodeficiency
Females who were pregnant, planning to become pregnant, or lactating (Women who, in the opinion of the investigator, were of childbearing potential were to have a negative pregnancy test before study drug administration.)
Subjects taking part in another study involving an investigational or licensed drug or device in the 3 months preceding enrollment or up to Week 12 during this study
Previous G17DT treatment
Hematological indicators as follows:
Any other condition or circumstance that might have the following results:
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |