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A Phase I open label study to asses the safety and tolerability of ZD6474 in combination with Irinotecan, 5-Fluorouracil and Leucovorin (FOLFIRI) as first or second line therapy in patients with metastatic colorectal adenocarcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZD6474 (vandetanib) 100mg | Experimental |
| |
| ZD6474 (vandetanib) 300mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZD6474 (vandetanib) 100mg | Drug | once daily oral tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Establish the safety & efficacy of ZD6474 w/5-fluorouracil,leucovorin & oxaliplatin to patients with advanced colorectal adenocarcinoma, by assessment of AEs, vital signs, clinical chemistry, hematology, urinalysis, ECG and physical examinations | assessed at each visit |
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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 | Ghent | Belgium | ||||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19184020 | Background | Saunders MP, Wilson R, Peeters M, Smith R, Godwood A, Oliver S, Van Cutsem E. Vandetanib with FOLFIRI in patients with advanced colorectal adenocarcinoma: results from an open-label, multicentre Phase I study. Cancer Chemother Pharmacol. 2009 Sep;64(4):665-72. doi: 10.1007/s00280-008-0914-4. Epub 2009 Jan 29. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D000230 | Adenocarcinoma |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C452423 | vandetanib |
| D000077146 | Irinotecan |
| D005472 | Fluorouracil |
| D002955 | Leucovorin |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D014498 | Uracil |
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| Irinotecan | Drug | intravenous infusion |
|
|
| 5-Fluorouracil | Drug | intravenous infusion |
|
|
| Leucovorin | Drug | intravenous infusion |
|
| ZD6474 (vandetanib) 300mg | Drug | once daily oral tablet |
|
|
| Belfast |
| United Kingdom |
| Research Site | Manchester | United Kingdom |
| CSR-D4200C00038.pdf | View source |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D011744 |
| Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |