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Study identifier: NCT04953910 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Acute Myeloid Leukemia · Myelodysplastic Syndromes  ·  Sponsor: Taiho Oncology, Inc.

PhasePhase 1
Planned participants27
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

This is a Phase 1b, multicenter, open-label, pharmacokinetic (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 moderate and severe hepatic impairment and cancer participants with normal hepatic function as control participants. Participants with severe hepatic impairment will be enrolled only after the safety evaluation of at least 6 participants with moderate hepatic impairment has been determined and supports the enrollment of participants with severe hepatic impairment. 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 is per participant approximately up to 8 weeks.

This description comes directly from the study's public registry record.

Talk to the study team

Taiho Oncology, Inc.  ·  +1 844-878-2446  ·  medicalinformation@taihooncology.com

Always discuss trial participation with your own doctor first.

Locations (22)

MD AndersonHouston, Texas, United StatesRecruiting
Erebuni Medical CenterYerevan, ArmeniaRecruiting
Hematology Center After Prof. R. Yeolyan (Adult Blood Disorders)Yerevan, ArmeniaRecruiting
Hematology Center After Prof. R. Yeolyan (Clinic of Adults Oncology)Yerevan, ArmeniaRecruiting
National Center of Oncology Named After V.A. FanarjyanYerevan, ArmeniaRecruiting
Complex Oncology Center - Plovdiv - Base IIPlovdiv, BulgariaWithdrawn
BIO1Vilnius, LithuaniaWithdrawn
Centrum Badań Klinicznych Piotr Napora Lekarze Sp. p.Wroclaw, PolandRecruiting
Institutul Oncologic Bucuresti - Prof. Dr. Alexandru TrestioreanuBucharest, RomaniaRecruiting
Institutul Oncologic Prof. Dr. Ion ChiricutaCluj-Napoca, RomaniaRecruiting
Summit Clinical Research s.r.oBratislava, SlovakiaRecruiting
START Barcelona - Hospital HM Nou DelfosBarcelona, SpainRecruiting

+ 10 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT04953910