Study of TLK199 Tablets in Myelodysplastic Syndrome (MDS)

May 30, 2012 updated by: Telik

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

49

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center
      • Maywood, Illinois, United States, 60153
        • Loyola University Chicago-Cardinal Bernardin Cancer Center
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts (UMass) Memorial Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:
  • Telintra
  • TLK199 Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum Tolerated Dose or Optimal Biologic Dose
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety Pharmacokinetic Parameters, Hematologic Response Parameters
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Telik

Investigators

  • Study Director: Gail Brown, MD, Telik

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

January 19, 2006

First Submitted That Met QC Criteria

January 19, 2006

First Posted (Estimate)

January 23, 2006

Study Record Updates

Last Update Posted (Estimate)

May 31, 2012

Last Update Submitted That Met QC Criteria

May 30, 2012

Last Verified

June 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TLK199.1101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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