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| Sponsor: | Novartis Pharmaceuticals |
|---|---|
| Information provided by: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00035243 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Neoplasms |
Drug: epothilone b |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
| Official Title: | An Open-Label Phase IIa Trial Evaluating the Safety and Efficacy of EPO906 as Therapy in Patients With Advanced Renal Cancer |
| Estimated Enrollment: | 53 |
| Study Start Date: | October 2007 |
| Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| EPO906: Experimental |
Drug: epothilone b
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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The following patients may be eligible for this study:
Exclusion Criteria:
The following patients are not eligible for this study:
Contacts and Locations| United States, California | |
| UCLA Medical Center | |
| Los Angeles, California, United States, 90095 | |
| United States, Maryland | |
| University of Maryland | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Michigan | |
| Wayne State University Karmanos Cancer Center | |
| Detroit, Michigan, United States, 48201 | |
| United States, New York | |
| Our Lady Of Mercy Medical Center | |
| Bronx, New York, United States, 10466 | |
| United States, Ohio | |
| Cleveland Clinic Foundation | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Washington | |
| University of Washington | |
| Seattle, Washington, United States, 98109 | |
| France | |
| Centre L. Berard | |
| Lyon, France | |
| Institut Gustave Roussy | |
| Villejuif, France | |
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
| Responsible Party: | Novartis Pharmaceuticals ( External Affairs ) |
| Study ID Numbers: | CEPO906A2207 |
| Study First Received: | May 2, 2002 |
| Last Updated: | November 12, 2009 |
| ClinicalTrials.gov Identifier: | NCT00035243 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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kidney cancer renal cancer cancer tumor tumour neoplasm carcinoma clear cell |
sarcomatoid papillary medullary collecting duct chromophobe intravenous epothilone |
|
Epothilone B Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Epothilones Mitosis Modulators Urogenital Neoplasms Antimitotic Agents Urologic Neoplasms |
Pharmacologic Actions Neoplasms Neoplasms by Site Urologic Diseases Kidney Neoplasms Therapeutic Uses Tubulin Modulators Kidney Diseases |