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The purpose of this study is to define th Maximum Tolerated Dose (MTD) and the recommended dose (RD) of ZD6474 in combination with a fixed standard dose of gemcitabine and capecitabine
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose level 1 | Active Comparator | Vandetanib 100mg/day plus Gemcitabine |
|
| Dose level 2 | Active Comparator | Vandetanib 300mg/day plus Gemcitabine |
|
| Dose level 3 | Active Comparator | Vandetanib 100mg/day plus Gemcitabine plus CapecitabineDose |
|
| Dose level 4 | Active Comparator | Vandetanib 300mg/day plus Gemcitabine plus CapectiabineDose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vandetanib | Drug | 100mg/300mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Define Maximum Tolerated Dose (MTD) | during whole study | |
| Define Recommended Dose (RD) | during whole study |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate safety profile | during whole study | |
| Determine antitumour activity as determined by overall response rate (RR), progression free survival (PFS), disease control rate and duration of response | every 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Sankt Gallen | Canton of St. Gallen | Switzerland | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21921646 | Background | Saletti P, Sessa C, De Dosso S, Cerny T, Renggli V, Koeberle D. Phase I dose-finding study of vandetanib in combination with gemcitabine in locally advanced unresectable or metastatic pancreatic adenocarcinoma. Oncology. 2011;81(1):50-4. doi: 10.1159/000330769. Epub 2011 Sep 15. |
| Label | URL |
|---|---|
| D4200L00003 CSR Synopsis | View source |
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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 |
|---|---|
| C452423 | vandetanib |
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| Bellinzona |
| Switzerland |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |