Clinical Trial

A Phase 1 Trial of ASTX030 in Patients With Myelodysplastic Syndrome

Recruiting Phase 1
View on ClinicalTrials.gov →
Summary
\[Tolerability Assessment Part\] The purpose is to identify the doses of the oral azacitidine(AZA) formulations and cedazuridine (CED) tablets which achieve a total AUC for AZA comparable to that for AZA injection at 75 mg/m2. \[Expansion Assessment Part\] The purpose is to compare the total AUC for AZA after administration of ASTX030 with that after administration of AZA injection at 75 mg/m2.
Protocol Amendment History 5 changes
critical Primary endpoint(s) modified 2026-08-11
notable Enrollment increased: 40 -> 59 participants 2026-08-11
minor Trial arms changed: 1 -> 3 2026-08-11
notable Primary completion pushed: 2025-12 -> 2027-12 2026-08-11
minor Completion pushed: 2026-01 -> 2028-01 2026-08-11
Trial Details
NCT Number NCT04608110
Lead Sponsor Taiho Pharmaceutical Co., Ltd.
Conditions Myelodysplastic Syndrome (MDS)
Enrollment 59 participants
Start Date 2020-10-30
Primary Completion 2027-12 (estimated)
Study Completion 2028-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-10