Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Cyclacel Pharmaceuticals, Inc.

Intervention(s):

  • Drug: Sapacitabine

Phase:

Phase 2

Eligibility


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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Daniel Navi
6507362300
Not Recruiting