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The Phase I part of the study will identify the doses of pazopanib and paclitaxel that can be administered safely in combination. The Phase II part of the study will not be progressed as documented in Protocol Amendment 01.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase I | Experimental | oral pazopanib once daily (Phase I starting dose 800 mg) and paclitaxel IV once every 3 weeks (Phase I starting dose 135 mg/m2). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pazopanib | Drug | oral pazopanib once daily (Phase I starting dose 800 mg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase I: safety and tolerability (Serious adverse events, adverse events, dose-limiting toxicities, clinical laboratory data, vital signs, ECG, ECOG performance status) | at least one cycle of treatment (3 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Phase I: paclitaxel and pazopanib pharmacokinetics | Cycle 1 and Cycle 2 PK sampling | |
| Phase I: clinical activity | at least 6 weeks |
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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 | Chicago | Illinois | 60637 | United States | ||
| GSK Investigational Site |
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| Label | URL |
|---|---|
| Results for study 111109 can be found on the GSK Clinical Study Register. | View source |
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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 |
|---|---|
| C516667 | pazopanib |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| paclitaxel | Drug | paclitaxel IV once every 3 weeks (Phase I starting dose 135 mg/m2). |
|
| Columbus |
| Ohio |
| 43210 |
| United States |
| GSK Investigational Site | Sutton | Surrey | SM2 5PT | United Kingdom |
| GSK Investigational Site | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |