Phase 1-2a Study of TLK199 HCl Liposomes for Injection in Myelodysplastic Syndrome
Phase 1/Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Myelodysplastic Syndromes
Both
Myelodysplastic Syndromes
Trial Information
Phase 1-2a Study of TLK199 HCl Liposomes for Injection in Myelodysplastic Syndrome
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Authority:
United States: Food and Drug Administration
Study ID:
TLK199.1001
NCT ID:
NCT00035867
Start Date:
April 2002
Completion Date:
May 2007
Related Keywords:
- Myelodysplastic Syndromes
- Myelodysplastic Syndromes
- Preleukemia
Name | Location |
|---|---|
| University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
| University of Alabama at Birmingham | Birmingham, Alabama 35294-3300 |
| Oregon Health & Science University | Portland, Oregon 97201 |
| M.D. Anderson Cancer Center | Houston, Texas 77030 |
| The Angeles Clinic & Research Institute | Los Angeles, California 90404 |
| University of Chicago | Chicago, Illinois 60637 |
| Midwest Cancer Research Group | Skokie, Illinois 60077 |
| The Sarah Cannon Cancer Center | Nashville, Tennessee 37203 |
| Texas Cancer Associates | Dallas, Texas 75231 |
