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The purpose of this study is to determine the bioequivalence of the new oral capsule formulation to the currently used oral capsule formulation of topotecan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All treated subjects | Experimental | Subjects were randomized to receive 4 mg of a new formulation and current formulation of oral topotecan on Days 1 and 8 of Course 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| topotecan | Drug | topotecan |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of blood levels of topotecan following oral and IV dosing; blood samples will be drawn on Day 1 and Day 8 of Courses 1 and 2. | Days 1, 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of clinical laboratory tests, cardiac monitoring and disease progression. Comparison of blood levels of topotecan when taken orally with and without food; blood samples will be drawn on Day 1 | Up to 38 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Lebanon | New Hampshire | 03756 | United States | ||
| GSK Investigational Site |
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| Label | URL |
|---|---|
| Results for study 104864/692 can be found on the GSK Clinical Study Register. | View source |
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| The Bronx |
| New York |
| 10461 |
| United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19111 | United States |
| GSK Investigational Site | Nashville | Tennessee | 37203 | United States |
| GSK Investigational Site | San Antonio | Texas | 78229 | United States |
| GSK Investigational Site | Morgantown | West Virginia | 26506 | United States |
| GSK Investigational Site | Amsterdam | 1066 CX | Netherlands |
| GSK Investigational Site | Utrecht | 3584 CX | Netherlands |
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| 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 |
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| ID | Term |
|---|---|
| D019772 | Topotecan |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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