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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT No.: 2005-000666-39 |
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The intention of this trial is to evaluate safety and efficacy of a combination treatment of EndoTAG-1 with Gemcitabine versus Gemcitabine monotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Gemcitabine |
|
| 2 | Experimental | EndoTag-1 + Gemcitabine |
|
| 3 | Experimental | EndoTag-1 + Gemcitabine |
|
| 4 | Experimental | EndoTag-1 + Gemcitabine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemcitabine alone | Drug | Gemcitabine monotherapy 1000 mg/m2 weekly |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | Median | |
| 6-month-survival-rate | 6 Months | |
| Overall survival | Median |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and percentage of patients with Adverse Events | 28 days after last patient out | |
| Number of clinically significant abnormal laboratory values | Last patient out |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthias Löhr, Prof. | Universitätsklinikum Mannheim | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prague | Czechia | |||||
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| EndoTAG-1 and Gemcitabine |
| Drug |
EndoTAG-1 11 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly |
|
| EndoTAG-1 and Gemcitabine | Drug | EndoTAG-1 22 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly |
|
| EndoTAG-1 and Gemcitabine | Drug | EndoTAG-1 44 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly |
|
| Budapest |
| Hungary |
| Kiev | Ukraine |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D009362 | Neoplasm Metastasis |
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| C511389 | MBT-0206 |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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