Study of TLK199 HCl Liposomes for Injection in Myelodysplastic Syndrome
Phase 1
Completed
- Conditions
- Myelodysplastic Syndromes
- Registration Number
- NCT00035867
- Lead Sponsor
- Telik
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 65
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (9)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
The Angeles Clinic & Research Institute
🇺🇸Los Angeles, California, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Midwest Cancer Research Group
🇺🇸Skokie, Illinois, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
The Sarah Cannon Cancer Center
🇺🇸Nashville, Tennessee, United States
Texas Cancer Associates
🇺🇸Dallas, Texas, United States
M.D. Anderson Cancer Center
🇺🇸Houston, Texas, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
University of Alabama at Birmingham🇺🇸Birmingham, Alabama, United States