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Brief Title: Study to Evaluate the Pharmacokinetics and Safety of Oral Decitabine and Cedazuridine in Cancer Patients With Hepatic Impairment
Official Title: 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
Study ID: NCT04953910
Brief 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 mg and cedazuridine 100 mg in cancer participants with moderate and severe hepatic impairment and cancer participants with normal hepatic function as control subjects. 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 approximately up to 8 weeks.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Complex Oncology Center - Plovdiv - Base II, Plovdiv, , Bulgaria
BIO1, Vilnius, , Lithuania
Centrum Badań Klinicznych Piotr Napora Lekarze Sp. p., Wrocław, , Poland
Institutul Oncologic Bucuresti - Prof. Dr. Alexandru Trestioreanu, Bucharest, , Romania
Institutul Oncologic Prof. Dr. Ion Chiricuta, Cluj-Napoca, , Romania
Summit Clinical Research s.r.o, Bratislava, , Slovakia
Hospital Universitari Dexeus - Grupo Quirónsalud, Barcelona, , Spain
Hospital Universitari Arnau de Vilanova, Lleida, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Clínico Universitario Virgen de la Arrixaca, Murcia, , Spain
Hospital Universitari i Politècnic La Fe, Valencia, , Spain