Myelodysplastic Syndrome Clinical Trial
Pharmacokinetic Guided Dose Escalation and Dose Confirmation With Oral Decitabine and Oral Cytidine Deaminase Inhibitor (CDAi) in Patients With Myelodysplastic Syndromes (MDS)
This first-in-human, 3-stage, open-label study evaluated the safety and pharmacokinetics of ASTX727, as well as determined the dose for later stages.
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.
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
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
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There are 17 Locations for this study
Phoenix Arizona, 85054, United States
Los Angeles California, 90024, United States
Chicago Illinois, 60637, United States
Lafayette Indiana, 47905, United States
Baltimore Maryland, 21231, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02215, United States
Hackensack New Jersey, 07601, United States
Buffalo New York, 14263, United States
New York New York, 10021, United States
Nashville Tennessee, 37232, United States
Houston Texas, 77030, United States
Milwaukee Wisconsin, 53226, United States
Edmonton Alberta, T6G 2, Canada
Toronto Ontario, M4N 3, Canada
Toronto Ontario, M5G 2, Canada
Montréal Quebec, H1T 2, Canada
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