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The purpose of this study is to determine the dose regimen of Ispinesib in combination with capecitabine in patients with solid tumors. Ispinesib is dosed by 1-hour intravenous infusion every 3 weeks and capecitabine is dosed orally, twice a day for 14 days with a 1 week rest period. A patient may continue to receive treatment as long as they are benefiting from the treatment. Blood samples will be taken at specific times to measure the amount of both drugs in your body at specific times after the drug is given. Blood samples will also be taken for lab tests such as complete blood counts and clinical chemistries. Physical exams will be performed before each treatment with Ispinesib. During the treatment phase, the patients will undergo regular assessments for safety and clinical response.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ispinesib | Drug | |||
| Capecitabine | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma levels for SB-715992 and Capecitabine | will be checked at Day 1 for Cycle 1. |
| Measure | Description | Time Frame |
|---|---|---|
| - Medical history | at screening | |
| - ECOG Performance Status, Physical Exam, vitals, & labs | done at screening, Week 1 (each cycle), & follow-up (f/u) | |
| - Continuous Adverse Event monitoring |
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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 | San Antonio | Texas | 78229 | United States |
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| ID | Term |
|---|---|
| C508757 | ispinesib |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
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| throughout the study |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |