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

Tracking Information
First Received Date ^ICMJE	May 6, 2002
Last Updated Date	May 30, 2008
Start Date ^ICMJE	April 2002
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00035867 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Study of TLK199 HCl Liposomes for Injection in Myelodysplastic Syndrome
Official Title ^ICMJE	Phase 1-2a Study of TLK199 HCl Liposomes for Injection in Myelodysplastic Syndrome
Brief Summary	The purpose of this study is to determine the safety and efficacy of TLK199 in patients with myelodysplastic syndrome (MDS).
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1 Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Myelodysplastic Syndromes
Intervention ^ICMJE	Drug: TLK199 HCl Liposomes for Injection
Study Arm (s)	Not Provided
Publications *	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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	65
Completion Date	May 2007
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00035867
Other Study ID Numbers ^ICMJE	TLK199.1001
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Telik
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Telik
Verification Date	June 2005
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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