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)
Sponsor:
Information provided by (Responsible Party):
Cyclacel Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00476554
First received: May 19, 2007
Last updated: November 7, 2011
Last verified: November 2011
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 27, 2014