A Randomized Phase II Study of Oral Sapacitabine in Patients With Advanced Cutaneous T-cell Lymphoma
NCT ID: NCT00476554
Last Updated: 2021-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
16 participants
INTERVENTIONAL
2007-04-30
2012-03-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
Sapacitabine
Sapacitabine
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
Sapacitabine
Sapacitabine
Interventions
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Sapacitabine
Sapacitabine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Cyclacel Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Judy H Chiao, M.D.
Role: STUDY_DIRECTOR
Cyclacel Pharmaceuticals, Inc.
Locations
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Stanford University Hospitals and Clinics
Stanford, California, United States
Timothy Kuzel, M.D.
Chicago, Illinois, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Other Identifiers
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CYC682-06-05
Identifier Type: -
Identifier Source: org_study_id
NCT00475995
Identifier Type: -
Identifier Source: nct_alias