Study of TLK199 Tablets in Myelodysplastic Syndrome (MDS)
Phase 1-2a Dose-Ranging Study of TLK199 Tablets in Myelodysplastic Syndrome (MDS)
1 other identifier
interventional
49
1 country
3
Brief Summary
The purpose of this study is to determine the safety and efficacy of TLK199 Tablets in patients with Myelodysplastic Syndrome (MDS)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Feb 2006
Typical duration for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 19, 2006
CompletedFirst Posted
Study publicly available on registry
January 23, 2006
CompletedStudy Start
First participant enrolled
February 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedMay 31, 2012
June 1, 2011
2.1 years
January 19, 2006
May 30, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Maximum Tolerated Dose or Optimal Biologic Dose
6 months
Secondary Outcomes (1)
Safety Pharmacokinetic Parameters, Hematologic Response Parameters
6 months
Study Arms (1)
1
EXPERIMENTALDose Escalation Study of TLK199 Tablets From 200 mg Per day To 6000 mg Per Day
Interventions
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.
Eligibility Criteria
You may qualify if:
- Histologically confirmed diagnosis of MDS
- 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
You may not qualify if:
- Prior bone marrow transplant
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Teliklead
Study Sites (3)
Loyola University Chicago-Cardinal Bernardin Cancer Center
Maywood, Illinois, 60153, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
University of Massachusetts (UMass) Memorial Medical Center
Worcester, Massachusetts, 01655, United States
Related Publications (1)
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.
PMID: 19398716DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gail Brown, MD
Telik
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2006
First Posted
January 23, 2006
Study Start
February 1, 2006
Primary Completion
March 1, 2008
Study Completion
June 1, 2008
Last Updated
May 31, 2012
Record last verified: 2011-06