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In this study 250 µg of G17DT was administered at Weeks 0, 2 and 6 in order to demonstrate non inferiority compared to gemcitabine in prolonging survival in advanced pancreatic cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| G17DT | Experimental | 250 µg/0.2 mL administered by intramuscular injection at Weeks 0, 2 and 6. 125 µg booster administered at Week 24. |
|
| Gemcitabine | Active Comparator | 1000 µg/m^2 intravenously administered once weekly for seven weeks starting at Week 0 followed by one week of rest. After, treatments will occur in cycles of 3 weeks of treatment followed by one week of rest. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| G17DT | Biological | 250 µg/0.2 mL administered by intramuscular injection at Weeks 0, 2 and 6. 125 µg booster administered at Week 24. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Survival | Survival in days measured starting at Baseline | Baseline (Week 0) up to Week 52 or death. |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Response | The proportion of patients having an objective tumor response using Computed Tomography (CT) and the Response Evaluation Criteria In Solid Tumors (RECIST). (RECIST) guidelines | Weeks 0, 12, 24, 36 and 52 |
| Quality of Life |
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Inclusion Criteria:
Serum creatinine < 1.25 times upper limit of normal (ULN) Haemoglobin > 9.5 g/dL White blood cell (WBC) count > 3.5 x 109/L Platelets > 100 x 109/L Total bilirubin < 2.0 times ULN Aspartate transaminase (AST, SGOT) < 3 times ULN
Exclusion Criteria:
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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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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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A randomized, open, parallel group, active comparator
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| Gemcitabine | Drug | 1000 µg/m^2 intravenously administered once weekly for seven weeks starting at Week 0 followed by one week of rest. After, treatments will occur in cycles of 3 weeks of treatment followed by one week of rest. |
|
|
Quality of life measured using Cancer Quality of Life Questionnaire EORTC-QLQC30 questionnaire
| Weeks 0, 6, 12, 24, 36 and 52 |
| Quality of Life | Quality of life measured using and the EORTC QLQ-PAN26 questionnaire | Weeks 0, 6, 12, 24, 36 and 52 |
| Karnofsky Performance Status | Functional impairment assessment using the Karnofsky Performance Scale Index | Week 0 to Week 52 |
| Gastrin-17 Antibodies | Antibody assessment to determine serum levels of Gastrin -17 antibodies | Weeks 0, 6, 12, 24, 36 and 52 |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |