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RECRUITING
NCT04953897
PHASE1

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

Sponsor: Taiho Oncology, Inc.

View on ClinicalTrials.gov

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 milligrams (mg) and cedazuridine 100 mg in cancer participants with severe renal impairment and cancer participants with normal renal function as matched control participants. 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 per participant is approximately up to 8 weeks.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2021-12-15

Completion Date

2026-12

Last Updated

2026-03-10

Healthy Volunteers

No

Interventions

DRUG

ASTX727

Multiple-dose oral administration of once-daily decitabine (35 mg) and cedazuridine (100 mg)

Locations (21)

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

Summit Clinical Research s.r.o

Bratislava, Slovakia

START Barcelona - Hospital HM Nou Delfos

Barcelona, Spain

Hospital Universitari Dexeus - Grupo Quirónsalud

Barcelona, Spain

START Rioja - Hospital de San Pedro

La Rioja, Spain

Hospital Universitari Arnau de Vilanova

Lleida, Spain

START Madrid - Hospital Universitario Fundación Jiménez Díaz

Madrid, Spain

START Madrid - CIOCC - HM Sanchinarro

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Clínico Universitario Virgen de la Arrixaca (Hematology Dept)

Murcia, Spain

Hospital Clínico Universitario Virgen de la Arrixaca (Solid Tumor Dept)

Murcia, Spain

Hospital Universitari i Politècnic La Fe

Valencia, Spain