A Single Agent Phase II Study of Romidepsin (Depsipeptide, FK228) in the Treatment of Cutaneous T-cell Lymphoma (CTCL)
Completed · Phase 2
Conditions studied: Cutaneous T-cell Lymphoma
In brief
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.
Key facts
- Study ID
- NCT00106431
- Run by
- Celgene
- People needed
- 102
- Starts
- 2005-01-01
- Expected to finish
- 2008-12-01
- Last updated by the study team
- 2019-10-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- UCLA Jonsson Cancer Center — Los Angeles, California, United States
- Stanford Comprehensive Cancer Center — Stanford, California, United States
- Boston Medical Center — Boston, Massachusetts, United States
- University of Pennsylvania Abrahamson Cancer Center — Philadelphia, Pennsylvania, United States
- Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States
- MD Anderson Cancer Center — Houston, Texas, United States
- Research Site — Multiple Locations, France
- Research Site — Multiple Locations, Germany
- Research Site — Multiple Locations, Poland
- Research Site — Multiple Locations, Russia
- Research Site — Multiple Locations, United Kingdom
Full record on ClinicalTrials.gov
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