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Spots Global Cancer Trial Database for Study to Evaluate the Pharmacokinetics and Safety of Oral Decitabine and Cedazuridine in Cancer Patients With Hepatic Impairment

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Trial Identification

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

Interventions

ASTX727

Study Description

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:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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