Study of TLK199 HCl Liposomes for Injection in Myelodysplastic Syndrome

May 30, 2008 updated by: Telik

Phase 1-2a Study of TLK199 HCl Liposomes for Injection in Myelodysplastic Syndrome

The purpose of this study is to determine the safety and efficacy of TLK199 in patients with myelodysplastic syndrome (MDS).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

65

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
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • California
      • Los Angeles, California, United States, 90404
        • The Angeles Clinic & Research Institute
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
      • Skokie, Illinois, United States, 60077
        • Midwest Cancer Research Group
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • The Sarah Cannon Cancer Center
    • Texas
      • Dallas, Texas, United States, 75231
        • Texas Cancer Associates
      • Houston, Texas, United States, 77030
        • M.D. Anderson Cancer Center
      • San Antonio, Texas, United States, 78229
        • University of Texas Health Science Center at San Antonio

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 or cytologically confirmed diagnosis of MDS
  • Adequate liver and kidney function
  • Ineligible for, or refusing, allogeneic bone marrow transplant
  • At least 18 years of age
  • Discontinuation of growth factors (e.g., G- CSF) at least 2 weeks prior to study entry

Exclusion Criteria:

  • Failure to recover from any prior surgery, or any major surgery within 4 weeks of study entry
  • Pregnant or lactating women
  • History of allergy to eggs
  • Other investigational drugs within 14 days of study entry
  • Chemotherapy, radiotherapy or immunotherapy within 14 days of study entry
  • Concomitant steroids or hormones for the treatment of neoplasms

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)

Collaborators and Investigators

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

Sponsor

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

April 1, 2002

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

May 6, 2002

First Submitted That Met QC Criteria

May 6, 2002

First Posted (Estimate)

May 7, 2002

Study Record Updates

Last Update Posted (Estimate)

June 3, 2008

Last Update Submitted That Met QC Criteria

May 30, 2008

Last Verified

June 1, 2005

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TLK199.1001

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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