Back to resultsStudy of TLK199 Tablets in Myelodysplastic Syndrome (MDS)
Primary Purpose
Myelodysplastic Syndrome (MDS)
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ezatiostat Hydrochlorine
Sponsored by
About this trial
This is an interventional treatment trial for Myelodysplastic Syndrome (MDS)
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Sites / Locations
- Loyola University Chicago-Cardinal Bernardin Cancer Center
- Loyola University Medical Center
- University of Massachusetts (UMass) Memorial Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Dose Escalation Study of TLK199 Tablets From 200 mg Per day To 6000 mg Per Day
Outcomes
Primary Outcome Measures
Maximum Tolerated Dose or Optimal Biologic Dose
Secondary Outcome Measures
Safety Pharmacokinetic Parameters, Hematologic Response Parameters
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00280631
Brief Title
Study of TLK199 Tablets in Myelodysplastic Syndrome (MDS)
Official Title
Phase 1-2a Dose-Ranging Study of TLK199 Tablets in Myelodysplastic Syndrome (MDS)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Telik
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine the safety and efficacy of TLK199 Tablets in patients with Myelodysplastic Syndrome (MDS)
Detailed Description
This Phase 1-2a study is an open label, dose-ranging study of TLK199 Tablets in patients with all World Health Organization or French-American-British classification types of myelodysplastic syndrome (MDS). In Phase 1, the safety, pharmacokinetics, and hematologic response rate with TLK199 Tablets will be evaluated. The Phase 1 dose-ranging stage is designed to determine the maximum tolerated dose or optimal biologic dose of TLK199 Tablets. Evaluation of the pharmacokinetics of TLK199 Tablets will be conducted. In Phase 1, an additional 12 patients will undergo pharmacokinetic evaluation under fed conditions at the selected Phase 2a dose. In Phase 2a, further safety and hematologic responses by the modified International Working Group MDS response criteria will be studied.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndrome (MDS)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Dose Escalation Study of TLK199 Tablets From 200 mg Per day To 6000 mg Per Day
Intervention Type
Drug
Intervention Name(s)
Ezatiostat Hydrochlorine
Other Intervention Name(s)
TLK199 Tablets, Telintra
Intervention Description
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.
Primary Outcome Measure Information:
Title
Maximum Tolerated Dose or Optimal Biologic Dose
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Safety Pharmacokinetic Parameters, Hematologic Response Parameters
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gail Brown, MD
Organizational Affiliation
Telik
Official's Role
Study Director
Facility Information:
Facility Name
Loyola University Chicago-Cardinal Bernardin Cancer Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
University of Massachusetts (UMass) Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19398716
Citation
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.
Results Reference
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Study of TLK199 Tablets in Myelodysplastic Syndrome (MDS)
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