A Randomized Phase II Study of Oral Sapacitabine in Patie... | NCT00476554

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

NCT00476554

Sponsor

Cyclacel Pharmaceuticals, Inc.

Status

Terminated

Last Update Posted

Dec 22, 2021Actual

Enrollment

16Actual

Phase

Phase 2

Conditions

Cutaneous T-cell Lymphoma (CTCL)

Interventions

Sapacitabine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

slow accrual and financial resource limitation

Expanded Access Info

Start Date

Apr 2007

Primary Completion Date

Mar 1, 2012Actual

Completion Date

Mar 1, 2012Actual

First Submitted Date

May 19, 2007

First Submission Date that Met QC Criteria

May 19, 2007

First Posted Date

May 22, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 7, 2021

Last Update Posted Date

Dec 22, 2021Actual

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Sapacitabine	Drug	Sapacitabine	Arm A: High dose Arm B: High dose

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Judy H Chiao, M.D.	Cyclacel Pharmaceuticals, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University Hospitals and Clinics		Stanford	California	94305	United States
Timothy Kuzel, M.D.

Condition Browse Module

MeSH Terms

ID	Term
D016410	Lymphoma, T-Cell, Cutaneous

Ancestor Terms

ID	Term
D016399	Lymphoma, T-Cell
D008228	Lymphoma, Non-Hodgkin
D008223	Lymphoma
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C117959	sapacitabine

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided