A Phase 2 interventional study of epothilone b in Kidney Neoplasms, sponsored by Novartis Pharmaceuticals. Completed at 8 sites in 2 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2012-04-17.
Sponsored by Novartis Pharmaceuticals · Phase 2, Interventional, and Treatment
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.
956 studies on the registry are indexed under Kidney Neoplasms; 210 are open to participants now.
This study's enrollment of 53 is above the median of 43 across 650 interventional studies indexed under Kidney Neoplasms.
Browse Kidney Neoplasms studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
The following patients may be eligible for this study:
Exclusion Criteria:
The following patients are not eligible for this study:
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.
Tumor response as assessed by radiologic techniques and/or physical examination based on Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: every 8 weeks
Objective response rate (ORR)
Time frame: every 8 weeks
Time to disease progression (TTP)
Time frame: every 8 weeks
Overall Survival (OS)
Time frame: every 8 weeks
Safety and tolerability of EPO906
Time frame: at each visit
Tumor-specific mutations and gene expression changes in tumor cells with blood cells and plasma
For biomarker development
Time frame: 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
This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.
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Novartis Pharmaceuticals