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

Sponsor

Cyclacel Pharmaceuticals, Inc. (Industry)

Overall Status

Terminated

CT.gov ID

NCT00476554

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

5.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Cutaneous T-cell Lymphoma (CTCL)	Drug: Sapacitabine	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2007

Actual Primary Completion Date :

Mar 1, 2012

Actual Study Completion Date :

Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm A: High dose High-dose (Arm A): 200 mg b.i.d. x 3 consecutive days per week for 2 weeks followed by 1-week rest	Drug: Sapacitabine Sapacitabine Other Names: CYC682
Experimental: Arm B: High dose Low-dose (Arm B): 100 mg b.i.d. x 3 consecutive days per week for 2 weeks followed by 1-week rest	Drug: Sapacitabine Sapacitabine Other Names: CYC682

Arm

Intervention/Treatment

Experimental: Arm A: High dose

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

Drug: Sapacitabine

Sapacitabine

Other Names:

CYC682

Experimental: Arm B: High dose

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

Drug: Sapacitabine

Sapacitabine

Other Names:

CYC682

Outcome Measures

Primary Outcome Measures

response rate in overall skin disease [over the course of study]
Decrease of lesion from baseline

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University Hospitals and Clinics	Stanford	California	United States	94305
2	Timothy Kuzel, M.D.	Chicago	Illinois	United States	60611
3	The University of Texas MD Anderson Cancer Center	Houston	Texas	United States	77030-4009