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| Name | Class |
|---|---|
| Amgen | INDUSTRY |
The purpose of the study is to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) | Drug | 800mg daily (2x 400mg tabs) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of progressions post randomization to placebo or sorafenib | 12 weeks post randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Time to progression | Until Progression occurs | |
| Duration of objective tumor response | Time from initial Response to documented Tumor Progression | |
| Overall survival time |
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Inclusion Criteria:
In addition, these patients must be monitored with weekly coagulation assessments throughout the Run-in Period)- Serum creatinine < 1.5 x upper limit of normal
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chicago | Illinois | 60637 | United States | |||
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| Label | URL |
|---|---|
| #PL#PubMed. | View source |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000077157 | Sorafenib |
| ID | Term |
|---|---|
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Placebo |
| Drug |
2x 400mg tabs daily |
|
| At the End-of-Study visit |
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| Houston | Texas | 77030 | United States |
| San Antonio | Texas | 78229 | United States |
| London | Greater London | SW3 6JJ | United Kingdom |
| Glasgow | Strathclyde | G11 6NT | United Kingdom |
| Sutton | Surrey | SM2 5PT | United Kingdom |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |