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Study of TLK199 HCl Liposomes for Injection in Myelodysplastic Syndrome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00035867
First Posted: May 7, 2002
Last Update Posted: June 3, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Telik
May 6, 2002
May 7, 2002
June 3, 2008
April 2002
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Complete list of historical versions of study NCT00035867 on ClinicalTrials.gov Archive Site
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Study of TLK199 HCl Liposomes for Injection in Myelodysplastic Syndrome
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).
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Myelodysplastic Syndromes
Drug: TLK199 HCl Liposomes for Injection
Not Provided
Raza A, Galili N, Callander N, Ochoa L, Piro L, Emanuel P, Williams S, Burris H 3rd, Faderl S, Estrov Z, Curtin P, Larson RA, Keck JG, Jones M, Meng L, Brown GL. Phase 1-2a multicenter dose-escalation study of ezatiostat hydrochloride liposomes for injection (Telintra, TLK199), a novel glutathione analog prodrug in patients with myelodysplastic syndrome. J Hematol Oncol. 2009 May 13;2:20. doi: 10.1186/1756-8722-2-20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
May 2007
Not Provided

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00035867
TLK199.1001
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Telik
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Not Provided
Telik
June 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP