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This study will examine whether the investigational drug EPO906, given by intravenous infusion (IV directly into the vein), is effective in shrinking tumors and preventing the growth of cells that cause kidney cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EPO906 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| epothilone b | Drug | EPO906 administered intravenously at 2.5 mg/m2 as a 5 minute bolus infusion repeated every week for three weeks followed by one week off The final tables and data is not in yet, so I cannot give you info on safety issues. |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor response as assessed by radiologic techniques and/or physical examination based on Response Evaluation Criteria in Solid Tumors (RECIST) | every 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | every 8 weeks | |
| Time to disease progression (TTP) | every 8 weeks | |
| Overall Survival (OS) |
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Inclusion Criteria:
The following patients may be eligible for this study:
Exclusion Criteria:
The following patients are not eligible for this study:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Medical Center | Los Angeles | California | 90095 | United States | ||
| University of Maryland |
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| Label | URL |
|---|---|
| Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers. | View source |
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| ID | Term |
|---|---|
| D007680 | Kidney Neoplasms |
| D009369 | Neoplasms |
| D002277 | Carcinoma |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C093788 | epothilone B |
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| every 8 weeks |
| Safety and tolerability of EPO906 | at each visit |
| Tumor-specific mutations and gene expression changes in tumor cells with blood cells and plasma | For biomarker development | prior to the first treatment with EPO906, on the day of any clinically indicated tumor biopsy/resection and on the day of each tumor assessment |
| Baltimore |
| Maryland |
| 21201 |
| United States |
| Wayne State University Karmanos Cancer Center | Detroit | Michigan | 48201 | United States |
| Our Lady Of Mercy Medical Center | The Bronx | New York | 10466 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| University of Washington | Seattle | Washington | 98109 | United States |
| Centre L. Berard | Lyon | France |
| Institut Gustave Roussy | Villejuif | France |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |