The purpose of this study is to evaluate the activity of FK228 in metastatic renal cell carcinoma (RCC) patients who have developed progressive disease (PD) following or during treatment with immunotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Patients receive 13 mg/m2 of romidepsin (FK228) intravenously over 4 hours on Days 1, 8, and 15 of each 28-day cycle.
City of Hope National Medical Center
Duarte, California, United States
University of Chicago
Chicago, Illinois, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
To evaluate the rate of objective response (the best response of Complete Response (CR), Partial Response (PR)).
Time frame: Up to 6 months
Rate of disease control, Complete Response, Partial Response, or Stable Disease
Time frame: Up to 6 months
Time to objective disease progression.
Time frame: Up to 6 months
Number of Participants with Adverse Events
Time frame: Up to 6 months
Change from screening assessment to the final study visit in Karnofsky performance status.
Time frame: Up to 6 months
Steady state plasma concentrations
Time frame: Up to 6 months
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