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Sponsored by: |
BioCryst Pharmaceuticals |
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Information provided by: | BioCryst Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00501735 |
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.
Condition | Intervention | Phase |
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T-Cell Lymphoma |
Drug: Forodesine 200 mg |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Single Agent Phase II Study of Forodesine (BCX1777) in the Treatment of Cutaneous T-Cell Lymphoma |
Estimated Enrollment: | 120 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Use of previous therapies for CTCL within the timeframes specified below:
Presence of any of the following ECG findings:
Contact: Jennifer Edmondson - USA | 919-859-7912 | jedmondson@biocryst.com |
Contact: Kathryn Hutchinson - Europe | 44-208-9562-606 | Kathryn.Hutchinson@ams-europe.com |
Principal Investigator: | Nashat Gabrail, MD | Gabrail Cancer Center |
Principal Investigator: | Madeleine Duvic, MD | M.D. Anderson Cancer Center - Dermatology |
Principal Investigator: | Youn Kim, MD | Stanford University |
Principal Investigator: | Andres Forero-Torres, M.D. | University of Alabama at Birmingham, Comprehensive Cancer Ctr. |
Principal Investigator: | Alexandra Kimball, MD, MPH | Brigham and Women's Hospital |
Principal Investigator: | Alan B Fleischer, Jr., MD | Wake Forest University |
Principal Investigator: | Gary S. Wood, MD | University of Wisconsin-Madison, Dept of Dermatology |
Principal Investigator: | Andre Goy, MD | Hackensack Universeity Medical Ctr |
Principal Investigator: | Larisa Geskin, MD | Hillman Cancer Ctr., University of Pittsburgh |
Principal Investigator: | Nancy Bartlett, MD | Washington University School of Medicine |
Principal Investigator: | Francine Foss, MD | Yale University |
Principal Investigator: | Miles Prince, MD | Cabrini Hospital |
Principal Investigator: | Elise Olsen, MD | Duke University |
Principal Investigator: | Sareeta S Parker, MD | Emory University |
Principal Investigator: | Neil J Korman, MD, PhD | University Hospitals Case Medical Ctr., Dept. of Dermatology |
Principal Investigator: | Francesco Turturro, MD | LSU Health Sciences Ctr., Feist-Weiller Cancer Center |
Principal Investigator: | Andrei R Shustov, MD | Seattle Cancer Care Alliance |
Responsible Party: | BioCryst Pharmaceuticals, Inc. ( W. James Alexander M.D., M.P.H / Snr VP Clinical & Regulatory Operations, CMO ) |
Study ID Numbers: | BCX1777-203 |
Study First Received: | July 12, 2007 |
Last Updated: | September 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00501735 |
Health Authority: | United States: Food and Drug Administration; Australia: Department of Health and Ageing Therapeutic Goods Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency; France: Afssaps - French Health Products Safety Agency; Switzerland: Swissmedic; Italy: Ethics Committee; Austria: Agency for Health and Food Safety |
T-Cell Lymphoma Forodesine |
Lymphatic Diseases Mycoses Sezary syndrome Immunoproliferative Disorders Cutaneous T-cell lymphoma Lymphoma, T-Cell |
Sezary Syndrome Mycosis Fungoides Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Lymphoma, T-Cell, Cutaneous |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |