Pharmacokinetic Guided Dose Escalation and Dose Confirmation With Oral Decitabine and Oral Cytidine Deaminase Inhibitor (CDAi) in Patients With Myelodysplastic Syndromes (MDS)
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Lead
Astex Pharmaceuticals, Inc.
The trial was designed to define daily doses of the individual components (cedazuridine \[E7727\] or decitabine) so that decitabine exposure after oral administration would be comparable to exposure after IV decitabine at the approved daily dose of 20 mg/m\^2. The main objective of Phases 1 and 2 was to establish and confirm the doses of the 2 components to be used in the final fixed-dose combination (FDC) product (ASTX727) using mainly pharmacokinetics and pharmacodynamics as endpoints.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
International Prognostic Scoring System (IPSS) low, intermediate -1, intermediate-2, or high risk MDS (including chronic myelomonocytic leukemia; CMML) in Dose Escalation and Dose Confirmation-Randomization; only intermediate-2, or high risk MDS in Dose Confirmation-Open Label
Eastern Cooperative Oncology Group (ECOG) 0 to 2
No major surgery within 2 weeks of starting study treatment
No cytotoxic chemotherapy within 2 weeks of starting study treatment
Able to swallow pills
You may not be if
Previous treatment with 2 or more courses of decitabine (all stages) or azacitidine (Dose Confirmation stage only)
Treatment with investigational therapy within 2 weeks of study treatment
Uncontrolled medical disease(s) or active, uncontrolled infection
Diagnosed with acute myeloid leukemia (AML)
Active uncontrolled gastric or duodenal ulcer
Known history of HIV or hepatitis C or B
Clareo Health | Pharmacokinetic Guided Dose Escalation and Dose Confirmation With Oral Decitabine and Oral Cytidine Deaminase Inhibitor (CDAi) in Patients With Myelodysplastic Syndromes (MDS)
