Trial Information
A Phase I Pharmacologic Study of Oral Sapacitabine in Patients With Advanced Leukemias or Myelodysplastic Syndromes
Inclusion Criteria:
- Adult patients with advanced leukemias or myelodysplastic syndromes defined in
section 4.1; Eastern Cooperative Oncology Group performance status 0-2; adequate
hepatic and renal function; ability to swallow capsules; be at least 2 weeks from
prior chemotherapy, radiation therapy, major surgery or other investigational
anticancer therapy; and have recovered from prior toxicities.
Exclusion Criteria:
- Patients with known CNS involvement by leukemia; plan to undergo allogeneic bone
marrow transplant within 4 weeks; currently on other investigational agents;
uncontrolled intercurrent illnesses; pregnant or lactating women; known to be HIV
positive
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:
CYC682-05-04
NCT ID:
NCT00380653
Start Date:
January 2006
Completion Date:
June 2009
Related Keywords:
- Leukemias
- Myelodysplastic Syndromes
- Leukemia
- Myelodysplastic Syndromes
- Preleukemia
Name | Location |
The University of Texas MD Anderson Cancer Center |
Houston, Texas 77030-4009 |