NCT00280631

Study of TLK199 Tablets in Myelodysplastic Syndrome (MDS)

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Telik · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myelodysplastic Syndrome (MDS)

Interventions

Type	Name	Description
DRUG	Ezatiostat 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.

Timeline

• Start date: 2006-02-01
• Primary completion: 2008-03-01
• Completion: 2008-06-01
• First posted: 2006-01-23
• Last updated: 2012-05-31

Locations

3 sites across 1 country: United States