Study of TLK199 Tablets in Myelodysplastic Syndrome (MDS)

Status Completed

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00280631
Study type	Interventional
Source	Telik
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	February 2006
Completion date	June 2008

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