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compound terminated
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This study is designed to evaluate the potential pharmacokinetic interaction between oral GW679769 and IV (intravenous) cyclophosphamide when administered to cancer patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | cyclophosphamide + dexamethasone + ondansetron |
|
| Arm B | Experimental | cyclophosphamide + dexamethasone + ondansetron + GW679769 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral GW679769 | Drug | 150mg oral, once daily on days 1-3 |
| |
| IV Cyclophosphamide 500-700mg/m2 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax and AUC of cyclophosphamide and 4-hydroxycyclophosphamideSafety and tolerability parameters including pharmacoeconomics, blood pressure, heart rate, ECG, laboratory tests, clinical observation and adverse event reporting. | throughout the study |
| Measure | Description | Time Frame |
|---|---|---|
| Terminal t1/2, Vd, and Cl of cyclophosphamideTerminal t1/2 of 4-hydroxycyclophosphamideAUC ratio of 4-hydroxycyclophosphamide and cyclophosphamideANC nadir | throughout the study |
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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 | Newark | Delaware | 19713 | United States | ||
| GSK Investigational Site |
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| Label | URL |
|---|---|
| Results for study NKV103444 can be found on the GSK Clinical Study Register. | View source |
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| ID | Term |
|---|---|
| D009325 | Nausea |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C531951 | casopitant |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
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| Drug |
IV Cyclophosphamide 500-700mg/m2 on day 1 of each cycle |
|
|
| Albuquerque |
| New Mexico |
| 87131 |
| United States |
| GSK Investigational Site | The Bronx | New York | 10461 | United States |
| GSK Investigational Site | Christchurch | 8011 | New Zealand |
| GSK Investigational Site | Lund | SE-221 85 | Sweden |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |