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A Phase 1b, Open-label, Parallel Group, Multiple-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Oral Decitabine and Cedazuridine (ASTX727) in Cancer Patients With Moderate and Severe Hepatic Impairment
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
MD Anderson
Houston, Texas, United States
Erebuni Medical Center
Yerevan, Armenia
Hematology Center After Prof. R. Yeolyan (Adult Blood Disorders)
Yerevan, Armenia
Hematology Center After Prof. R. Yeolyan (Clinic of Adults Oncology)
Yerevan, Armenia
National Center of Oncology Named After V.A. Fanarjyan
Yerevan, Armenia
Complex Oncology Center - Plovdiv - Base II
Plovdiv, Bulgaria
BIO1
Vilnius, Lithuania
Centrum Badań Klinicznych Piotr Napora Lekarze Sp. p.
Wroclaw, Poland
Institutul Oncologic Bucuresti - Prof. Dr. Alexandru Trestioreanu
Bucharest, Romania
Institutul Oncologic Prof. Dr. Ion Chiricuta
Cluj-Napoca, Romania
Start Date
December 23, 2022
Primary Completion Date
December 1, 2026
Completion Date
December 1, 2026
Last Updated
March 10, 2026
27
ESTIMATED participants
ASTX727
DRUG
Lead Sponsor
Taiho Oncology, Inc.
NCT06285890
NCT06220162
NCT04065399
Data Source & Attribution
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