Forodesine in the Treatment of Cutaneous T-Cell Lymphoma

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

DRUG

Forodesine 200 mg

2 x 100mg tablets once daily

Sponsors & Collaborators

• BioCryst Pharmaceuticals

  lead INDUSTRY

Principal Investigators

• 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.

• 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

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-07-31

Primary Completion

2010-07-31

Completion

2011-12-31

Countries

• United States
• Australia
• Austria
• Finland
• France
• Germany
• Italy
• Spain
• Switzerland
• United Kingdom

Study Locations