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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
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Telik:

Primary Outcome Measures:
  • Maximum Tolerated Dose or Optimal Biologic Dose [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety Pharmacokinetic Parameters, Hematologic Response Parameters [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Telik

Additional 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
Study First Received: January 19, 2006
Last Updated: May 30, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Preleukemia
Bone Marrow Diseases
 Hematologic Diseases
Precancerous Conditions
Neoplasms

ClinicalTrials.gov processed this record on May 16, 2013