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

Cyclacel Pharmaceuticals

Status and phase: Terminated; Phase 2

Conditions: Cutaneous T-cell Lymphoma (CTCL)

Treatments: Drug: Sapacitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00476554

CYC682-06-05

Details and patient eligibility

About

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).

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Arm A: High dose

Experimental group

Description:

High-dose (Arm A): 200 mg b.i.d. x 3 consecutive days per week for 2 weeks followed by 1-week rest

Treatment:

Drug: Sapacitabine

Arm B: High dose

Experimental group

Description:

Low-dose (Arm B): 100 mg b.i.d. x 3 consecutive days per week for 2 weeks followed by 1-week rest

Treatment:

Drug: Sapacitabine