A Single Agent Phase II Study of Romidepsin (Depsipeptide, FK228) in the Treatment of Cutaneous T-cell Lymphoma (CTCL)
Status:
Completed
Trial end date:
2008-12-01
Target enrollment:
Participant gender:
Summary
GPI-04-0001 was a Phase II, non-randomized, open label, single arm study that was conducted
at approximately 30 sites, primarily in the United States, Europe and Russia. It assessed the
efficacy, safety, and tolerability of romidepsin as a treatment for cutaneous T-cell lymphoma
(CTCL). Study patients (pts) received romidepsin in a dose of 14 mg/m^2 intravenously over 4
hours on Days 1, 8 and 15 of each 28-day cycle. The duration of study treatment was 6 cycles
although pts who showed an objective response or stable disease could continue to receive
therapy, at the discretion of the investigator, until disease progression or another
withdrawal criterion was met.