NCT00501735

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 144 (actual)
• Sponsor: BioCryst Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Cutaneous T-cell Lymphoma (CTCL),

Interventions

Type	Name	Description
DRUG	Forodesine 200 mg	2 x 100mg tablets once daily

Timeline

• Start date: 2007-07-01
• Primary completion: 2010-07-01
• Completion: 2011-12-01
• First posted: 2007-07-16
• Last updated: 2012-01-23

Locations

41 sites across 10 countries: United States, Australia, Austria, Finland, France, Germany, Italy, Spain, Switzerland, United Kingdom