NCT00476554

TerminatedPhase 2

A Randomized Phase II Study of Oral Sapacitabine in Patients...

Cyclacel Pharmaceuticals, Inc.Source

Cyclacel Pharmaceuticals, Inc.

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

CYC682-06-05

Study Type

interventional

Actual enrollment (reported)

16

Locations

1 country

Sites

3

Timeline

Study Start

April 2007

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

March 1, 2012

Actual (reported)

Study Completion

March 1, 2012

Actual (reported)

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).

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: terminated
Actual enrollment (reported): 16 participants
Study completion date: March 1, 2012
Actual (reported)
Listed locations: 1 countries · 3 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
April 2007
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
May 19, 2007
Actual (reported)
First Posted
May 22, 2007
Actual (reported)
Primary Completion
March 1, 2012
Actual (reported)
Study Completion
March 1, 2012
Actual (reported)

Last Updated: December 22, 2021
Status Verified: December 2021
Last Update Submitted: December 7, 2021

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

SapacitabineDrug

Sapacitabine

Also known as: CYC682

Arm A: High doseArm B: High dose

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Adult patients with advanced CTCL
Have had at least 2 systemic therapies

Sponsors & Collaborators

Cyclacel Pharmaceuticals, Inc.
Industrylead

Study Sites (3)

Stanford University Hospitals and Clinics

Stanford, California, 94305, United States

Timothy Kuzel, M.D.

Chicago, Illinois, 60611, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

MeSH Terms

Conditions

Lymphoma, T-Cell, Cutaneous

Interventions

sapacitabine

Condition Hierarchy (Ancestors)

Lymphoma, T-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

Judy H Chiao, M.D.
Cyclacel Pharmaceuticals, Inc.
STUDY DIRECTOR

Enrollment

16 participants (actual enrollment reported by the registry).

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 2007

Date type not reported

This date has not been verified as actual or estimated.

NCT00425555

Study of Oral LBH589 in Adult Patients With Refractory Cutaneous T-Cell Lymphoma

Phase 2Completed

NCT01843998

Therapeutic Efficacy of Topical Sirolimus in Early Stage Cutaneous T-cell Lymphoma (CTCL)

Phase 2Withdrawn

NCT01132989

Open-label Pilot Study of Lenalidomide (Revlimid) as Adjuvant Treatment for Refractory Cutaneous T Cell Lymphoma

Phase 2Unknown

NCT02213861

Efficacy, Safety and Tolerability Study of SHAPE in IA, IB or IIA Cutaneous T-cell Lymphoma

Phase 2Unknown

NCT00501735

Forodesine in the Treatment of Cutaneous T-Cell Lymphoma

Phase 2Completed

NCT00431912

A Study of APO866 for the Treatment of Cutaneous T-cell Lymphoma

Phase 2Completed

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

Contact the study team to confirm eligibility.

Primary Completion

March 1, 2012

Actual (reported)

Study Completion

March 1, 2012

Actual (reported)

Last Updated

December 22, 2021

Record last verified: 2021-12

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00476554
Data provider: ClinicalTrials.gov
Source updated: 2021-12-22
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:24:21 UTC

Locations

US(3)

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Arm A: High dose

Arm B: High dose

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Arm A: High dose

Arm B: High dose

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations