Status:
COMPLETED
Safety and Pharmacology Study of Sapacitabine to Treat Advanced Leukemias or Myelodysplastic Syndromes
Lead Sponsor:
Cyclacel Pharmaceuticals, Inc.
Conditions:
Leukemias
Myelodysplastic Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The goal of this safety/pharmacology study is to determine MTD of sapacitabine when administered in patients with advanced leukemias or myelodysplastic syndromes.
Detailed Description
The goal of this study is to find the highest tolerable dose of sapacitabine that can be given to patients with advanced leukemias or myelodysplastic syndromes.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00380653
Start Date
January 1 2006
End Date
June 1 2009
Last Update
December 13 2021
Active Locations (1)
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1
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009