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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
53
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.
UCLA Medical Center
Los Angeles, California, United States
University of Maryland
Baltimore, Maryland, United States
Wayne State University Karmanos Cancer Center
Detroit, Michigan, United States
Our Lady Of Mercy Medical Center
The Bronx, New York, United States
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
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Cleveland Clinic Foundation
Cleveland, Ohio, United States
University of Washington
Seattle, Washington, United States
Centre L. Berard
Lyon, France
Institut Gustave Roussy
Villejuif, France