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A 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
Cyclacel Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cutaneous T-cell Lymphoma (CTCL) focused on measuring CTCL

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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

First Posted
May 19, 2007
Last Updated
December 7, 2021
Sponsor
Cyclacel Pharmaceuticals, Inc.
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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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