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RecruitingPhase 1NCT04953910

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

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

Sponsor

Taiho Oncology, Inc.

Enrollment

27 participants

Start Date

Dec 23, 2022

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid LeukemiaMyelodysplastic Syndromes

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 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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating how liver problems (hepatic impairment) affect the way the body handles an oral cancer drug combination (decitabine and cedazuridine) used for blood cancers like AML and MDS, and some solid tumors. By comparing patients with normal liver function to those with moderate or severe liver disease, researchers aim to determine appropriate dosing for this population. **You may be eligible if...** - You have a confirmed cancer (blood cancer or solid tumor) for which standard treatments are no longer available - Your liver function falls into one of three categories: normal, moderately impaired, or severely impaired - Your kidney function is adequate (creatinine clearance above 50 mL/min) - You are in reasonably good health (ECOG 0–3) - Your life expectancy is at least 3 months **You may NOT be eligible if...** - You received azacitidine or decitabine in the last 4 weeks - You have been hospitalized for severe infection in the last 30 days - You have HIV, or active hepatitis B or C - You have uncontrolled serious medical conditions or significant heart problems - You are pregnant or breastfeeding - You have a known allergy to decitabine or cedazuridine - You have a history of alcohol or drug abuse Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGASTX727

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

Locations(22)

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

Hospital Universitario La Paz

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

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NCT04953910

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