Study of TLK199 Tablets in Myelodysplastic Syndrome (MDS)

Telik

Status and phase

Completed

Phase 2

Phase 1

Conditions

Myelodysplastic Syndrome (MDS)

Treatments

Drug: Ezatiostat Hydrochlorine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00280631

TLK199.1101

Details and patient eligibility

About

The purpose of this study is to determine the safety and efficacy of TLK199 Tablets in patients with Myelodysplastic Syndrome (MDS)

Full 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.

Enrollment

49 patients

Sex

All

Ages

18+ years old

Volunteers

No 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