Clinical Trial

Study to Evaluate the Pharmacokinetics and Safety of Oral Decitabine and Cedazuridine in Cancer Patients With Renal Impairment

Recruiting Phase 1
View on ClinicalTrials.gov →
Summary
This is a Phase 1b, multicenter, open-label, PK, and safety study of multiple oral doses of oral decitabine and cedazuridine (formerly known as ASTX727) as a fixed-dose combination of decitabine 35 milligrams (mg) and cedazuridine 100 mg in cancer participants with severe renal impairment and cancer participants with normal renal function as matched control participants. Adult participants with acute myeloid lymphoma (AML), myelodysplastic syndrome (MDS), or solid tumors who are candidates to receive oral decitabine and cedazuridine will be enrolled in this study. Study duration per participant is approximately up to 8 weeks.
Protocol Amendment History 22 amendments
This ClinicalTrials.gov record has been amended 22 times since 2021-06-30; most recent amendment 2026-05-27.
Status change: Not Yet Recruiting → Recruiting 2022-01-21
Trial Details
NCT Number NCT04953897
Lead Sponsor Taiho Oncology, Inc.
Conditions Acute Myeloid Leukemia, Myelodysplastic Syndromes
Enrollment 18 participants
Start Date 2021-12-15
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-05-28