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Study of TLK199 Tablets in Myelodysplastic Syndrome (MDS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00280631
First Posted: January 23, 2006
Last Update Posted: May 31, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Telik
  Purpose
The purpose of this study is to determine the safety and efficacy of TLK199 Tablets in patients with Myelodysplastic Syndrome (MDS)

Condition Intervention Phase
Myelodysplastic Syndrome (MDS) Drug: Ezatiostat Hydrochlorine Phase 1 Phase 2

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Telik:

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

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

Enrollment: 49
Study Start Date: February 2006
Study Completion Date: June 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 Submitted: January 19, 2006
First Posted: January 23, 2006
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