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Study of TLK199 Tablets in Myelodysplastic Syndrome (MDS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Telik
ClinicalTrials.gov Identifier:
NCT00280631
First received: January 19, 2006
Last updated: May 30, 2012
Last verified: June 2011

January 19, 2006
May 30, 2012
February 2006
March 2008   (final data collection date for primary outcome measure)
Maximum Tolerated Dose or Optimal Biologic Dose [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00280631 on ClinicalTrials.gov Archive Site
Safety Pharmacokinetic Parameters, Hematologic Response Parameters [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Study of TLK199 Tablets in Myelodysplastic Syndrome (MDS)
Phase 1-2a Dose-Ranging 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)

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.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Myelodysplastic Syndrome (MDS)
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.
Other Names:
  • TLK199 Tablets
  • Telintra
Experimental: 1
Dose Escalation Study of TLK199 Tablets From 200 mg Per day To 6000 mg Per Day
Intervention: Drug: Ezatiostat Hydrochlorine
Raza A, Galili N, Smith S, Godwin J, Lancet J, Melchert M, Jones M, Keck JG, Meng L, Brown GL, List A. Phase 1 multicenter dose-escalation study of ezatiostat hydrochloride (TLK199 tablets), a novel glutathione analog prodrug, in patients with myelodysplastic syndrome. Blood. 2009 Jun 25;113(26):6533-40. Epub 2009 Apr 27.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
49
June 2008
March 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00280631
TLK199.1101
No
Telik
Telik
Not Provided
Study Director: Gail Brown, MD Telik
Telik
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP