Clinical Trial

A Study for Participants Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose)

Enrolling by Invitation Phase 2
View on ClinicalTrials.gov →
Summary
Extension study to provide ongoing long-term treatment with ASTX727 for participants who were benefitting from ASTX727 treatment in a previous Taiho (formerly Astex)-sponsored clinical study of ASTX727 (including, but not limited to ASTX727-01 \[NCT02103478\], ASTX727-02 \[NCT03306264\], ASTX727-04 \[NCT03813186\]), ASTX727-06 \[NCT04093570\] food effect substudy, ASTX727-17 \[NCT04953897\], and ASTX727-18 \[NCT04953910\] to obtain long-term safety information. The purpose of the Food Effect Substudy was to evaluate the pharmacokinetics (PK) and safety of decitabine and cedazuridine when ASTX727 was given under fed (high-calorie/high-fat meal or low-calorie/low-fat meal) versus fasted conditions. Food Effect Substudy has now completed.
Protocol Amendment History 31 amendments
This ClinicalTrials.gov record has been amended 31 times since 2019-09-16; most recent amendment 2026-07-27.
Status change: Not Yet Recruiting → Enrolling by Invitation 2019-10-11
Trial Details
NCT Number NCT04093570
Lead Sponsor Taiho Oncology, Inc.
Conditions Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, Myelodysplastic Syndromes
Enrollment 332 participants
Start Date 2019-09-30
Primary Completion 2027-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-28