NCT00501735|CompletedPhase 2DMC
Forodesine in the Treatment of Cutaneous T-Cell Lymphoma
Single Agent Phase II Study of Forodesine (BCX1777) in the Treatment of Cutaneous T-Cell Lymphoma
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Sponsor study identifier
interventional
144
10 countries
41
Study Start
July 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2010
Actual (reported)Study Completion
December 2011
Actual (reported)This is a Phase II, non-randomized, open-label, single-arm trial that will be conducted at up to 50 sites in North America, Europe and Australia. This study is designed to assess objective response (OR) \[complete response (CR) or partial response (PR)\] in subjects with cutaneous manifestations of CTCL with a requirement for maintenance of such objective response for at least 28 days in subjects with stage IIB, III, and IVA CTCL. Additionally, this study will evaluate the safety and tolerability of CTCL subjects Stages IB, IIA, IIB, III, or IVA treated with oral forodesine.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2011
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2007
Date type not reportedThis date has not been verified as actual or estimated.
July 12, 2007
Actual (reported)July 16, 2007
Actual (reported)July 2010
Actual (reported)December 2011
Actual (reported)The primary objective of this study is to determine the objective response rate to treatment with oral forodesine in subjects with cutaneous manifestations of CTCL subjects, stages IIB, III, and IVA.
Duration of Study
Safety and tolerability
Duration of Study
Time to and duration of objective response in cutaneous manifestations
Duration of Study
Time to loss of objective response
Duration of Study
Objective response rate, time to and duration of extracutaneous manifestations
Duration of Study
Health related quality of life
Duration of Study
2 x 100mg tablets once daily
University of Alabama at Birmingham, Comprehensive Cancer Ctr
Birmingham, Alabama, 35294-3300, United States
Stanford University Medical Center
Stanford, California, 94305, United States
Yale Cancer Center
New Haven, Connecticut, 06520, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Emory University
Atlanta, Georgia, 30322, United States
LSU Health Sciences Center, Feist-Weiller Cancer Center
Shreveport, Louisiana, 71103, United States
Boston Medical Center
Dummer R, Duvic M, Scarisbrick J, Olsen EA, Rozati S, Eggmann N, Goldinger SM, Hutchinson K, Geskin L, Illidge TM, Giuliano E, Elder J, Kim YH. Final results of a multicenter phase II study of the purine nucleoside phosphorylase (PNP) inhibitor forodesine in patients with advanced cutaneous T-cell lymphomas (CTCL) (Mycosis fungoides and Sezary syndrome). Ann Oncol. 2014 Sep;25(9):1807-1812. doi: 10.1093/annonc/mdu231. Epub 2014 Jun 19.
Nashat Gabrail, MD
Gabrail Cancer Center
Madeleine Duvic, MD
M.D. Anderson Cancer Center - Dermatology
Youn Kim, MD
Stanford University
Andres Forero-Torres, M.D.
University of Alabama at Birmingham, Comprehensive Cancer Ctr.
144 participants (actual enrollment reported by the registry).
First Submitted
July 12, 2007
First Posted
July 16, 2007
Study Start
July 2007
Date type not reportedThis date has not been verified as actual or estimated.
Study of Oral LBH589 in Adult Participants With Refractory/Resistant Cutaneous T-Cell Lymphoma (CTCL)
Contact the study team to confirm eligibility.
Boston, Massachusetts, 02118, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Hackensack University Medical Ctr
Hackensack, New Jersey, 07601, United States
Upstate Medical University
Syracuse, New York, 13210, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Wake Forest University Health Sceinces, Dept. of Dermatology
Winston-Salem, North Carolina, 27157, United States
Gabrail Cancer Center
Canton, Ohio, 44718, United States
University Hospitals Case Medical Center, Dept. of Dermatology
Cleveland, Ohio, 44106, United States
Hospital at the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Hillman Cancer Ctr., University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
M.D. Anderson Cancer Center - Dermatology
Houston, Texas, 77030, United States
Seattle Cancer Care Alliance
Seattle, Washington, 89109, United States
University of Wisconsin-Madison, Dept of Dermatology
Madison, Wisconsin, 53715, United States
Cabrini Hospital
Malvern, Victoria, 3144, Australia
Wien
Vienna, 1090, Austria
Helsinki
Helsinki, FIN-00029 HUS, Finland
Hopital Hotel-Dieu
Clermont-Ferrand, 63058, France
Creteil
Créteil, 94000, France
Montpellier
Montpellier, 34295, France
Pessac
Pessac, 33600, France
CHU Robert Debre
Reims, 51092, France
Toulouse
Toulouse, 31059, France
Campus Charité Mitte
Berlin, D10117, Germany
Universitatsklinikum Jena
Jena, 07740, Germany
Universitat Kiel
Kiel, 24105, Germany
Klinik fur Dermatologie, Venerologie und Allergologie
Mannheim, 68163, Germany
Bologna
Bologna, 40138, Italy
Firenze
Florence, 50121, Italy
Milan
Milan, 20122, Italy
Rome
Rome, 00167, Italy
Torino
Torino, 10126, Italy
Madrid
Madrid, 28041, Spain
Zurich
Zurich, CH-8091, Switzerland
London
London, SE1 7EH, United Kingdom
Manchester
Manchester, M20 4BX, United Kingdom
Alan B Fleischer, Jr., MD
Wake Forest University Health Sciences
Gary S. Wood, MD
University of Wisconsin-Madison, Dept of Dermatology
Andre Goy, MD
Hackensack Universeity Medical Ctr
Larisa Geskin, MD
Hillman Cancer Ctr., University of Pittsburgh
Nancy Bartlett, MD
Washington University School of Medicine
Francine Foss, MD
Yale University
Miles Prince, MD
Cabrini Hospital
Elise Olsen, MD
Duke University
Sareeta S Parker, MD
Emory University
Neil J Korman, MD, PhD
University Hospitals Case Medical Ctr., Dept. of Dermatology
Francesco Turturro, MD
LSU Health Sciences Ctr., Feist-Weiller Cancer Center
Andrei R Shustov, MD
Seattle Cancer Care Alliance
Primary Completion
July 2010
Actual (reported)Study Completion
December 2011
Actual (reported)Last Updated
January 23, 2012
Record last verified: 2012-01
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