Trials / Completed
CompletedNCT00098332
Forodesine (BCX-1777) in Treating Patients With Refractory Stage IIA, Stage IIB, Stage III, Stage IVA, or Stage IVB Cutaneous T-Cell Lymphoma
A Phase I, Multi-Center, Open-Label, Safety and Pharmacokinetic, Repeat-Dose Study of Oral Forodesine Hydrochloride in Patients With Refractory Cutaneous T-Cell Lymphoma
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- BioCryst Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
RATIONALE: Forodesine (BCX-1777) may stop the growth of cancer cells by blocking the enzymes necessary for their growth. PURPOSE: Phase I trial to study the effectiveness of BCX-1777 in treating patients who have refractory stage IIA, stage IIB, stage III, stage IVA, or stage IVB cutaneous T-cell lymphoma.
Detailed description
OBJECTIVES: * Determine the safety and efficacy of forodesine (BCX-1777) in patients with refractory stage IIA-IVB cutaneous T-cell lymphoma. * Determine the pharmacokinetics and pharmacodynamics of this drug in these patients. OUTLINE: This is an open-label, multicenter study. Patients receive oral forodesine (BCX-1777) once daily on days 1-28. Courses may be repeated in the absence of disease progression or unacceptable toxicity. Patients are followed periodically. PROJECTED ACCRUAL: Not specified.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | forodesine hydrochloride |
Timeline
- Start date
- 2004-11-01
- Primary completion
- 2010-12-01
- Completion
- 2011-07-01
- First posted
- 2004-12-08
- Last updated
- 2013-07-10
Locations
10 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00098332. Inclusion in this directory is not an endorsement.