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Study of TLK199 HCl Liposomes for Injection in Myelodysplastic Syndrome

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ClinicalTrials.gov Identifier: NCT00035867
Recruitment Status : Completed
First Posted : May 7, 2002
Last Update Posted : June 3, 2008
Sponsor:
Information provided by:
Telik

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

Condition or disease Intervention/treatment Phase
Myelodysplastic Syndromes Drug: TLK199 HCl Liposomes for Injection Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 65 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1-2a Study of TLK199 HCl Liposomes for Injection in Myelodysplastic Syndrome
Study Start Date : April 2002
Actual Study Completion Date : May 2007

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U.S. FDA Resources





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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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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): 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

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
First Posted: May 7, 2002    Key Record Dates
Last Update Posted: June 3, 2008
Last Verified: June 2005

Additional relevant MeSH terms:
Syndrome
Myelodysplastic Syndromes
Preleukemia
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms