Spots Global Cancer Trial Database for Study to Evaluate the Pharmacokinetics and Safety of Oral Decitabine and Cedazuridine in Cancer Patients With Renal 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 Renal 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 Severe Renal Impairment and Cancer Patients With Normal Renal Function
Study ID: NCT04953897
Interventions
Study Description
Brief Summary: 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 mg and cedazuridine 100 mg in cancer participants with severe renal impairment and cancer participants with normal renal function as matched control subjects. 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
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