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

May 19, 2007
November 7, 2011
April 2007
March 2012   (final data collection date for primary outcome measure)
response rate in overall skin disease [ Time Frame: over the course of study ] [ Designated as safety issue: No ]
response rate in overall skin disease
Complete list of historical versions of study NCT00476554 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Randomized Phase II Study of Oral Sapacitabine in Patients With Advanced Cutaneous T-cell Lymphoma
Not Provided

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Cutaneous T-cell Lymphoma (CTCL)
Drug: Sapacitabine
Sapacitabine
  • Experimental: A
    low dose
    Intervention: Drug: Sapacitabine
  • Experimental: B
    High dose
    Intervention: Drug: Sapacitabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
32
March 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00476554
CYC682-06-05
Not Provided
Cyclacel Pharmaceuticals, Inc.
Cyclacel Pharmaceuticals, Inc.
Not Provided
Study Director: Judy H Chiao, M.D. Cyclacel Pharmaceuticals, Inc.
Cyclacel Pharmaceuticals, Inc.
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP