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

• Status: Terminated
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

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) who have had progressive, recurrent, or persistent disease on or following 2 systemic therapies.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cyclacel Pharmaceuticals, Inc.
• Treatments: Sapacitabine

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