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NCT00106431 · ClinicalTrials.gov registry record · Phase 2
A Single Agent Phase II Study of Romidepsin (Depsipeptide, FK228) in the Treatment of Cutaneous T-cell Lymphoma (CTCL)
A Phase 2 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 2
- Development phase
- 102
- Enrollment target
NCT00106431 is a Phase 2 study that has completed, run by Celgene. The registered enrollment target is 102 participants.
The verdict
NCT00106431, a Phase 2 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 102 participants
- Enrollment target
Study 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.
Interventions
- DRUG romidepsin (depsipeptide, FK228)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2005-01-01 |
| Est. Completion | 2008-12-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00106431
The ClinicalTrials.gov registry entry for NCT00106431 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 102 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Celgene, which has 308 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which romidepsin (depsipeptide, FK228) is the first listed.
NCT00106431 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00106431 about?
NCT00106431 is a clinical study titled "A Single Agent Phase II Study of Romidepsin (Depsipeptide, FK228) in the Treatment of Cutaneous T-cell Lymphoma (CTCL)". 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 patien...
What is the current status of trial NCT00106431?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 102 participants. The study started on 2005-01-01. Estimated completion is 2008-12-01.
What interventions are being tested in trial NCT00106431?
The interventions under investigation include: romidepsin (depsipeptide, FK228) (DRUG).
Who is sponsoring clinical trial NCT00106431?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
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