A Randomized Phase II Study of Oral Sapacitabine in Patients With Advanced Cutaneous T-cell Lymphoma
- Registration Number
- NCT00476554
- Lead Sponsor
- Cyclacel Pharmaceuticals, Inc.
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 16
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm B: High dose Sapacitabine Low-dose (Arm B): 100 mg b.i.d. x 3 consecutive days per week for 2 weeks followed by 1-week rest Arm A: High dose Sapacitabine High-dose (Arm A): 200 mg b.i.d. x 3 consecutive days per week for 2 weeks followed by 1-week rest
- Primary Outcome Measures
Name Time Method response rate in overall skin disease over the course of study Decrease of lesion from baseline
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Stanford University Hospitals and Clinics
🇺🇸Stanford, California, United States
Timothy Kuzel, M.D.
🇺🇸Chicago, Illinois, United States
The University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States