search
Back to results

Study of TLK199 HCl Liposomes for Injection in Myelodysplastic Syndrome

Primary Purpose

Myelodysplastic Syndromes

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TLK199 HCl Liposomes for Injection
Sponsored by
Telik
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myelodysplastic Syndromes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham
  • The Angeles Clinic & Research Institute
  • University of Chicago
  • Midwest Cancer Research Group
  • Oregon Health & Science University
  • The Sarah Cannon Cancer Center
  • Texas Cancer Associates
  • M.D. Anderson Cancer Center
  • University of Texas Health Science Center at San Antonio

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 6, 2002
Last Updated
May 30, 2008
Sponsor
Telik
search

1. Study Identification

Unique Protocol Identification Number
NCT00035867
Brief Title
Study of TLK199 HCl Liposomes for Injection in Myelodysplastic Syndrome
Official Title
Phase 1-2a Study of TLK199 HCl Liposomes for Injection in Myelodysplastic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
June 2005
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Telik

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndromes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
65 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
TLK199 HCl Liposomes for Injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
The Angeles Clinic & Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Midwest Cancer Research Group
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
The Sarah Cannon Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Texas Cancer Associates
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
M.D. Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19439093
Citation
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.
Results Reference
derived

Learn more about this trial

Study of TLK199 HCl Liposomes for Injection in Myelodysplastic Syndrome

We'll reach out to this number within 24 hrs