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Study of TLK199 HCl Liposomes for Injection in Myelodysplastic Syndrome

This study has been completed.
Sponsor:
Information provided by:
Telik
ClinicalTrials.gov Identifier:
NCT00035867
First received: May 6, 2002
Last updated: May 30, 2008
Last verified: June 2005
History of Changes
  Purpose

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


Condition Intervention Phase
Myelodysplastic Syndromes
 Drug: TLK199 HCl Liposomes for Injection
 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 Study of TLK199 HCl Liposomes for Injection in Myelodysplastic Syndrome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Telik:

Estimated Enrollment: 65
Study Start Date: April 2002
Study Completion Date: May 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00035867

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

No publications provided by Telik

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00035867     History of Changes
Other Study ID Numbers: TLK199.1001
Study First Received: May 6, 2002
Last Updated: May 30, 2008
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 22, 2013