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This study was designed to determine how effective and safe Ispinesib is in treating locally advanced or metastatic Non-small Cell Lung cancer in patients who have received a platinum-based chemotherapy and whose disease continues to progress. Treatment involves a 1-hr treatment given intravenously (IV), repeated once every 21 days. A patient may continue treatment as long as they are benefiting from the treatment. Blood samples will be taken at specific times over 24 hr period to measure the amount of drug in your body at specific times after the drug is given. Blood samples will also be taken for routine lab tests such as complete blood counts and clinical chemistries. Physical exams will be performed before each treatment.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ispinesib | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Overall Response Rate of tumor. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability: adverse events, changes from baseline in vital signs and clinical laboratory parameters. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials, MD | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Scottsdale | Arizona | 85259 | United States | ||
| GSK Investigational Site |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C508757 | ispinesib |
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| Jacksonville |
| Florida |
| 32224 |
| United States |
| GSK Investigational Site | Rochester | Minnesota | 55905 | United States |
| GSK Investigational Site | Rochester | New York | 14623 | United States |
| GSK Investigational Site | Greensboro | North Carolina | 27403 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19111 | United States |
| GSK Investigational Site | Memphis | Tennessee | 38104 | United States |
| GSK Investigational Site | Brussels | 1000 | Belgium |
| GSK Investigational Site | Edegem | 2650 | Belgium |
| GSK Investigational Site | Leuven | 3000 | Belgium |
| GSK Investigational Site | Sutton | Surrey | SM2 5PT | United Kingdom |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |