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

December 7, 2021 updated by: Cyclacel Pharmaceuticals, Inc.
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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University Hospitals and Clinics
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Timothy Kuzel, M.D.
    • Texas
      • Houston, Texas, United States, 77030-4009
        • The University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
response rate in overall skin disease
Time Frame: over the course of study
Decrease of lesion from baseline
over the course of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cyclacel Pharmaceuticals, Inc.

Investigators

  • Study Director: Judy H Chiao, M.D., Cyclacel Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

May 19, 2007

First Submitted That Met QC Criteria

May 19, 2007

First Posted (Estimate)

May 22, 2007

Study Record Updates

Last Update Posted (Actual)

December 22, 2021

Last Update Submitted That Met QC Criteria

December 7, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CYC682-06-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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