Study of TLK199 HCl Liposomes for Injection in Myelodysplastic Syndrome

Completed · Phase 1/Phase 2

Conditions studied: Myelodysplastic Syndromes

In brief

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

Key facts

Study ID: NCT00035867
Run by: Telik
People needed: 65
Starts: 2002-04-01
Expected to finish: 2007-05-01
Last updated by the study team: 2008-06-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

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

Full record on ClinicalTrials.gov

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