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Completed

NCT Number: NCT00280631

Study of TLK199 Tablets in Myelodysplastic Syndrome (MDS)

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

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Key information

Conditions

Myelodysplastic Syndrome (MDS) Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Myelodysplastic Syndromes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ezatiostat Hydrochlorine

Drug

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.

Other names: TLK199 Tablets, Telintra

Primary outcomes

  1. Maximum Tolerated Dose or Optimal Biologic Dose

    Time frame: 6 months

Secondary outcomes

  1. Safety Pharmacokinetic Parameters, Hematologic Response Parameters

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Telik

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jan 23, 2006
Registry last updated
May 31, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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