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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
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham
Birmingham, Alabama, United States
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States
Stanford Comprehensive Cancer Center - Stanford
Stanford, California, United States
University of Colorado Cancer Center at UC Health Sciences Center
Aurora, Colorado, United States
Yale Cancer Center
New Haven, Connecticut, United States
Cancer and Blood Disease Center
Lecanto, Florida, United States
Dana-Farber/Brigham and Women's Cancer Center
Boston, Massachusetts, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States
Start Date
November 1, 2004
Primary Completion Date
December 1, 2010
Completion Date
July 1, 2011
Last Updated
July 10, 2013
forodesine hydrochloride
DRUG
Lead Sponsor
BioCryst Pharmaceuticals
NCT07388563
NCT05529069
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