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Australia

AUSTRALIA: VICTORIA
Single Agent Phase II Study of Forodesine (BCX1777) in the Treatment of Cutaneous T-Cell Lymphoma

PURPOSE: This study will enroll subjects with CTCL stages IB, IIA, IIB, III and IVA. The goal of this study is to determine if the investigational drug Forodesine Hydrochloride is a safe and effective treatment for cutaneous T-cell lymphoma or Sézary syndrome. Approximately 150 patients will participate in this study in up to 50 centers across North America, Europe, and Australia.

INCLUSION:
1. Males or non-pregnant femails aged ≥ 18 years
2. Histologically confirmed diagnosis of CTCL, including mycosis fungoides and/or Sézary syndrome
3. Subjects with CTCL stages IB, IIA, IIB, III and IVA
4. Must have failed 3 forms of systemic therapy, one of which must have been oral bexarotene, unless not tolerated or was medically contraindicated

EXCLUSION:
1. Proven or suspected extracutaneous visceral CTCL involvement (presence of lymphadenopathy is permitted)
2. Previous treatment with Forodesine
3. Concurrent treatment with any other anti-CTCL therapy

Protocal number: BioCryst Protocol BCX1777-203
Sponsor: BioCryst Pharmaceuticals Inc.
Identifier for www.clinicaltrials.gov: NCT00501735

CONTACT
Terina Sylvester
terina_sylvester@internode.on.net

Jennifer Edmondson
BioCryst Pharmaceuticals
919-859-7912

Principal Investigator: Miles Prince, MD