Study of TLK199 Tablets in Myelodysplastic Syndrome (MDS)

Phase 1

Completed

• Conditions: Myelodysplastic Syndrome (MDS)
• Interventions: Drug: Ezatiostat Hydrochlorine

• Registration Number: NCT00280631
• Lead Sponsor: Telik

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.

Study Timeline

• Study First Submitted: 2006-01-19
• Study First Submitted QC: 2006-01-19
• Study First Posted: 2006-01-23
• Study Start: 2006-02
• Primary Completion: 2008-03
• Study Completion: 2008-06
• Status Verified: 2011-06
• Last Update Submitted: 2012-05-30
• Last Update Posted: 2012-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Ezatiostat Hydrochlorine	Dose Escalation Study of TLK199 Tablets From 200 mg Per day To 6000 mg Per Day

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose or Optimal Biologic Dose	6 months

Secondary Outcome Measures

Name	Time	Method
Safety Pharmacokinetic Parameters, Hematologic Response Parameters	6 months

Trial Locations

Locations (3)

University of Massachusetts (UMass) Memorial Medical Center; 🇺🇸 Worcester, Massachusetts, United States

Loyola University Chicago-Cardinal Bernardin Cancer Center; 🇺🇸 Maywood, Illinois, United States

Loyola University Medical Center; 🇺🇸 Maywood, Illinois, United States