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

NCT00476554 | Terminated Phase 2

• 1 other identifier: CYC682-06-05
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 3

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).

Conditions

Cutaneous T-cell Lymphoma (CTCL)

Keywords

CTCL

Outcome Measures

Primary Outcomes (1)

• response rate in overall skin disease

  Decrease of lesion from baseline

  over the course of study

Study Arms (2)

Arm A: High dose

EXPERIMENTAL

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

Arm B: High dose

EXPERIMENTAL

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

Interventions

Sapacitabine DRUG

Sapacitabine

Also known as: CYC682

Arm A: High dose; Arm B: High dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cyclacel Pharmaceuticals, Inc.: lead

Study Sites (3)

Stanford University Hospitals and Clinics

Stanford, California, 94305, United States

Location

Timothy Kuzel, M.D.

Chicago, Illinois, 60611, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

MeSH Terms

Conditions

Lymphoma, T-Cell, Cutaneous

Interventions

sapacitabine

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Judy H Chiao, M.D.

  Cyclacel Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2007
• First Posted: May 22, 2007
• Study Start: April 1, 2007
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: December 22, 2021

Record last verified: 2021-12

Locations

US (3)