Leukemias, Myelodysplastic Syndromes
Conditions
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.
Interventions
DRUGsapacitabine
Sponsors
Cyclacel Pharmaceuticals, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The starting dose is (A) 75 mg twice daily x 7 days followed by 14 days of rest or, (B) 375 mg twice daily x 3 consecutive days per week for 2 weeks followed by 7days of rest. Evaluated doses in schedule A: 75mg, 100mg, 125mg, 175mg, 225mg, 275mg, 325mg and 375mg Evaluated doses in schedule B: 375mg, 425mg and 475mg
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum tolerated dose | Through study completion, average of 1 year | dose limiting toxicities; during first cycle, each cycle is three weeks |
Countries
United States
Outcome results
None listed