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| ID | Type | Description | Link |
|---|---|---|---|
| EUDRACT Number 2008-005556-24 |
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Very slow recruitment
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A clinical study to investigate the maximum tolerated dose of Vandetanib and concurrent WBRT in patients with NSCLC and brain metastases. All patients will receive WBRT, 10 fractions of 3 Gy. Patients will start 7 days prior to start of radiation treatment with Vandetanib. Total treatment time with Vandetanib is 3 weeks (21 days). Patients will have the opportunity to continue Vandetanib until progression at a dose of 300 mg. This multi-centre study will be conducted in a minimum of 9 patients and a maximum of 18 patients at 3 sites.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZACTIMA TM | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZD6474 (Vandetanib) | Drug | 100 mg as a once daily oral dose, 21 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| To investigate the maximum tolerated dose of Vandetanib and concurrent WBRT in patients with NSCLC and brain metastases | All evaluable patients (all registered patients who receive at least opne dose of study medication) who have completed week 9 study period |
| Measure | Description | Time Frame |
|---|---|---|
| To investigate the time to clinical and radiological progression of brain metastases | Until disease progression |
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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 | Amsterdam | Netherlands | ||||
| Research site |
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| Whole Brain Radiotherapy (WBRT) | Radiation |
|
| ZD6474 | Drug | 200 mg as a once daily oral dose, 21 days |
|
|
| ZD6474 | Drug | 300 mg as a once daily oral dose, 21 days |
|
|
| Groningen |
| Netherlands |
| Research site | Maastricht | Netherlands |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C452423 | vandetanib |
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