Back to resultsA Randomized Phase II Study of Oral Sapacitabine in Patients With Advanced Cutaneous T-cell Lymphoma
Primary Purpose
Cutaneous T-cell Lymphoma (CTCL)
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Sapacitabine
Sponsored by
About this trial
This is an interventional treatment trial for Cutaneous T-cell Lymphoma (CTCL) focused on measuring CTCL
Eligibility 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
Sites / Locations
- Stanford University Hospitals and Clinics
- Timothy Kuzel, M.D.
- The University of Texas MD Anderson Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Arm A: High dose
Arm B: High dose
Arm Description
High-dose (Arm A): 200 mg b.i.d. x 3 consecutive days per week for 2 weeks followed by 1-week rest
Low-dose (Arm B): 100 mg b.i.d. x 3 consecutive days per week for 2 weeks followed by 1-week rest
Outcomes
Primary Outcome Measures
response rate in overall skin disease
Decrease of lesion from baseline
Secondary Outcome Measures
Full Information
NCT ID
NCT00476554
First Posted
May 19, 2007
Last Updated
December 7, 2021
Sponsor
Cyclacel Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00476554
Brief Title
A Randomized Phase II Study of Oral Sapacitabine in Patients With Advanced Cutaneous T-cell Lymphoma
Official Title
A Randomized Phase II Study of Oral Sapacitabine in Patients With Advanced Cutaneous T-cell Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Terminated
Why Stopped
slow accrual and financial resource limitation
Study Start Date
April 2007 (undefined)
Primary Completion Date
March 1, 2012 (Actual)
Study Completion Date
March 1, 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cyclacel Pharmaceuticals, Inc.
4. Oversight
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous T-cell Lymphoma (CTCL)
Keywords
CTCL
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A: High dose
Arm Type
Experimental
Arm Description
High-dose (Arm A): 200 mg b.i.d. x 3 consecutive days per week for 2 weeks followed by 1-week rest
Arm Title
Arm B: High dose
Arm Type
Experimental
Arm Description
Low-dose (Arm B): 100 mg b.i.d. x 3 consecutive days per week for 2 weeks followed by 1-week rest
Intervention Type
Drug
Intervention Name(s)
Sapacitabine
Other Intervention Name(s)
CYC682
Intervention Description
Sapacitabine
Primary Outcome Measure Information:
Title
response rate in overall skin disease
Description
Decrease of lesion from baseline
Time Frame
over the course of study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judy H Chiao, M.D.
Organizational Affiliation
Cyclacel Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Stanford University Hospitals and Clinics
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Timothy Kuzel, M.D.
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Randomized Phase II Study of Oral Sapacitabine in Patients With Advanced Cutaneous T-cell Lymphoma
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