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Study of TLK199 Tablets in Myelodysplastic Syndrome (MDS)

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ClinicalTrials.gov Identifier: NCT00280631
Recruitment Status : Completed
First Posted : January 23, 2006
Last Update Posted : May 31, 2012
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Myelodysplastic Syndrome (MDS) Drug: Ezatiostat Hydrochlorine Phase 1 Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1-2a Dose-Ranging Study of TLK199 Tablets in Myelodysplastic Syndrome (MDS)
Study Start Date : February 2006
Primary Completion Date : March 2008
Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Dose Escalation Study of TLK199 Tablets From 200 mg Per day To 6000 mg Per Day
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


Outcome Measures

Primary Outcome Measures :
  1. Maximum Tolerated Dose or Optimal Biologic Dose [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Safety Pharmacokinetic Parameters, Hematologic Response Parameters [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00280631


Locations
United States, Illinois
Loyola University Chicago-Cardinal Bernardin Cancer Center
Maywood, Illinois, United States, 60153
Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Massachusetts
University of Massachusetts (UMass) Memorial Medical Center
Worcester, Massachusetts, United States, 01655
Sponsors and Collaborators
Telik
Investigators
Study Director: Gail Brown, MD Telik
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Telik
ClinicalTrials.gov Identifier: NCT00280631     History of Changes
Other Study ID Numbers: TLK199.1101
First Posted: January 23, 2006    Key Record Dates
Last Update Posted: May 31, 2012
Last Verified: June 2011

Additional relevant MeSH terms:
Syndrome
Myelodysplastic Syndromes
Preleukemia
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms