The purpose of this study is to evaluate the safety and tolerability of extended treatment with FK228 in patients with metastatic renal cell carcinoma or hormone refractory prostate cancer who have at least demonstrated stable disease on prior Fujisawa sponsored FK228 clinical trials.
This is a Phase II, non-randomized, open-label, single arm, continuation trial.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Patients were continued at the same dose of romidepsin as in the previous study, which could have been 13 mg/m2 or a reduced dose of 10 mg/m2, administered 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 Florida
Gainesville, Florida, United States
University of Chicago
Chicago, Illinois, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
Number of participants with adverse events
Time frame: Up to 6 months
To evaluate the effect of depsipeptide therapy on performance status as measured by the Karnofsky score assessment
Time frame: Up to 6 months
To evaluate the time to objective disease progression.
Time frame: Up to 6 months
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Royal Marsden Hospital
Sutton, United Kingdom