Study of TLK199 Tablets in Myelodysplastic Syndrome (MDS)

Phase 1-2a Dose-Ranging Study of TLK199 Tablets in Myelodysplastic Syndrome (MDS)

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00280631

Enrollment

Registered

2006-01-23

Start date

2006-02-28

Completion date

2008-06-30

Last updated

2012-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelodysplastic Syndrome (MDS)

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.

Interventions

DRUGEzatiostat 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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Maximum Tolerated Dose or Optimal Biologic Dose	6 months

Secondary

Measure	Time frame
Safety Pharmacokinetic Parameters, Hematologic Response Parameters	6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026