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Phase 1-2a Study of TLK199 HCl Liposomes for Injection in Myelodysplastic Syndrome


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Myelodysplastic Syndromes

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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 AntonioSan Antonio, Texas  78284-7811
University of Alabama at BirminghamBirmingham, Alabama  35294-3300
Oregon Health & Science UniversityPortland, Oregon  97201
M.D. Anderson Cancer CenterHouston, Texas  77030
The Angeles Clinic & Research InstituteLos Angeles, California  90404
University of ChicagoChicago, Illinois  60637
Midwest Cancer Research GroupSkokie, Illinois  60077
The Sarah Cannon Cancer CenterNashville, Tennessee  37203
Texas Cancer AssociatesDallas, Texas  75231