A Randomized Phase II Study of Oral Sapacitabine in Patients With Advanced Cutaneous T-cell Lymphoma

This study has been terminated.

( slow accrual and financial resource limitation )

First Received on May 19, 2007. Last Updated on November 7, 2011 History of Changes

Sponsor:	Cyclacel Pharmaceuticals, Inc.
Information provided by (Responsible Party):	Cyclacel Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00476554

Purpose

This is an open label, randomized phase II study designed to evaluate the tolerability and response rate of high-dose and low-dose regimens in patients with advanced cutaneous T-cell lymphoma (CTCL) who have had progressive, recurrent, or persistent disease on or following 2 systemic therapies.

Condition	Intervention	Phase
Cutaneous T-cell Lymphoma (CTCL)	Drug: Sapacitabine	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma

U.S. FDA Resources

Further study details as provided by Cyclacel Pharmaceuticals, Inc.:

Primary Outcome Measures:

response rate in overall skin disease [ Time Frame: over the course of study ] [ Designated as safety issue: No ]

Estimated Enrollment:	32
Study Start Date:	April 2007
Estimated Study Completion Date:	March 2012
Estimated Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A low dose	Drug: Sapacitabine Sapacitabine
Experimental: B High dose	Drug: Sapacitabine Sapacitabine

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adult patients with advanced CTCL
Have had at least 2 systemic therapies
Must have evaluable disease
Eastern Cooperative Oncology Group performance status 0-2
Adequate bone marrow, hepatic and renal function
At least 3 weeks from prior therapies
Not receiving topical steroids or have been on a stable dose of topical steroids for at least 2 weeks
Able to swallow capsules
At least 3 weeks from major surgery
Agree to practice effective contraception
Able to understand and willing to sign the informed consent form

Exclusion Criteria:

Receiving systemic steroids
Receiving topical or systemic retinoids or vitamin A
Receiving radiotherapy, biological therapy,or any other investigational agents
Uncontrolled intercurrent illness
Pregnant or lactating women
Known to be HIV-positive
Active hepatitis B and/or hepatitis C infection

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00476554

Locations

United States, California
Stanford University Hospitals and Clinics
Stanford, California, United States, 94305
United States, Illinois
Timothy Kuzel, M.D.
Chicago, Illinois, United States, 60611
United States, Texas
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009

Sponsors and Collaborators

Cyclacel Pharmaceuticals, Inc.

Investigators

Study Director:

Judy H Chiao, M.D.

Cyclacel Pharmaceuticals, Inc.

More Information

No publications provided

Responsible Party:	Cyclacel Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00476554 History of Changes
Obsolete Identifiers:	NCT00475995
Other Study ID Numbers:	CYC682-06-05
Study First Received:	May 19, 2007
Last Updated:	November 7, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Cyclacel Pharmaceuticals, Inc.:

CTCL

Additional relevant MeSH terms:

Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Neoplasms

Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin

ClinicalTrials.gov processed this record on May 22, 2012