Study of TLK199 Tablets in Myelodysplastic Syndrome (MDS)
NCT ID: NCT00280631
Last Updated: 2012-05-31
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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COMPLETED
PHASE1/PHASE2
49 participants
INTERVENTIONAL
2006-02-28
2008-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Dose Escalation Study of TLK199 Tablets From 200 mg Per day To 6000 mg Per Day
Ezatiostat Hydrochlorine
Oral Tablets in 2 Divided Doses, Dose Escalation From 200 mg Per Day to 6000 mg Per Day on Days 1-7 of each 21 Day Cycle.
Interventions
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Ezatiostat Hydrochlorine
Oral Tablets in 2 Divided Doses, Dose Escalation From 200 mg Per Day to 6000 mg Per Day on Days 1-7 of each 21 Day Cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Documented significant cytopenia for at least 2 months
* Adequate liver and kidney function
* Ineligible for stem cell bone marrow transplantation
* At least 18 years of age
* Discontinuation of growth factors (e.g., G-CSF) within 3 weeks of study entry
Exclusion Criteria
* Failure to recover from any prior surgery or any major surgery within 4 weeks of study entry
* Pregnant or lactating women
* Other investigational drugs within 14 days of study entry
* Chemotherapy, radiotherapy or immunotherapy within 14 days of study entry
18 Years
ALL
No
Sponsors
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Telik
INDUSTRY
Responsible Party
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Principal Investigators
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Gail Brown, MD
Role: STUDY_DIRECTOR
Telik
Locations
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Loyola University Chicago-Cardinal Bernardin Cancer Center
Maywood, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
University of Massachusetts (UMass) Memorial Medical Center
Worcester, Massachusetts, United States
Countries
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References
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Raza A, Galili N, Smith S, Godwin J, Lancet J, Melchert M, Jones M, Keck JG, Meng L, Brown GL, List A. Phase 1 multicenter dose-escalation study of ezatiostat hydrochloride (TLK199 tablets), a novel glutathione analog prodrug, in patients with myelodysplastic syndrome. Blood. 2009 Jun 25;113(26):6533-40. doi: 10.1182/blood-2009-01-176032. Epub 2009 Apr 27.
Other Identifiers
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TLK199.1101
Identifier Type: -
Identifier Source: org_study_id