This study will examine whether the new 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 melanoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
51
intravenous 2.5 mg/m2 as a 5 minutes bolus infusion once every week for three weeks followed by one week off
University of Colorado
Aurora, Colorado, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Comprehensive Cancer Center@ Our Lady if Mercy Medical Center
The Bronx, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Tumor response (complete response (CR), partial response (PR), stable disease (SD))
Objective tumor response was defined by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines assessed by radiologic techniques and/or physical examination.
Time frame: at screening, at least every eight weeks (one week following the last dose of EPO906 in every even-numbered cycle)
Number and percentage of patients with Adverse events
Safety and tolerabilty of EPO906: Safety assessments consisted of monitoring and recording of all adverse events (AEs) and serious adverse events (SAEs), the regular monitoring of hematology, blood chemistry and urine values, regular measurement of vital signs and the performance status.
Time frame: as necessary
Objective response rate (ORR)
Time frame: at screening, at least every eight weeks (one week following the last dose of EPO906 in every even-numbered cycle)
Time to disease progression (TTP)
Time frame: at screening, at least every eight weeks (one week following the last dose of EPO906 in every even-numbered cycle)
Overall Survival (OS)
Time frame: from the date of the first dose of treatment to date of death from any cause, or the last date the patient is known to be alive
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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Oklahoma Oncology, Inc.
Tulsa, Oklahoma, United States
UPMC Health Systems
Pittsburgh, Pennsylvania, United States