Actively Recruiting
Study to Evaluate the Pharmacokinetics and Safety of Oral Decitabine and Cedazuridine in Cancer Patients With Hepatic Impairment
Led by Taiho Oncology, Inc. · Updated on 2026-04-30
27
Participants Needed
22
Research Sites
205 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study to Evaluate the Pharmacokinetics and Safety of Oral Decitabine and Cedazuridine in Cancer Patients With Hepatic Impairment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and comply with study procedures and provide informed consent
- Have a confirmed diagnosis of metastatic or unresectable solid tumor without standard life-prolonging options, or diagnosis of AML or MDS, or other hematologic malignancy without standard life-prolonging options
- For AML/MDS participants: confirmed diagnosis per 2008 WHO classification, or frontline MDS/treatment-naive AML not suitable for induction therapy
- Platelet count \u226525,000 per microliter and absolute neutrophil count \u2265100 cells/\u03bcL for AML/MDS participants
- For other hematologic malignancies or solid tumors: platelet count \u2265100,000/\u03bcL and ANC \u22651000 cells/\u03bcL
- ECOG performance status between 0 and 3
- Hepatic function classified as normal, moderate impairment, or severe impairment per NCI CTEP criteria
- Adequate kidney function with creatinine clearance over 50 mL/min
- No major surgery within 30 days before first drug dose
- Life expectancy of at least 3 months
- Women of childbearing potential must not be pregnant or breastfeeding, must have negative pregnancy test, and agree to use effective contraception
- Male participants with female partners of childbearing potential must agree to use condoms and advise partner to use effective contraception
You will not qualify if you...
- Treatment with azacitidine or decitabine within 4 weeks before screening
- Recent hospitalization over 2 days for febrile neutropenia, pneumonia, sepsis, or systemic infection within 30 days before first dose
- Treatment with investigational or other cancer therapies within 2 weeks or 5 half-lives before first dose, or ongoing adverse events from prior treatment
- Concurrent MDS therapies except certain short-term uses approved by physician
- Administration of live vaccines within 4 weeks before first dose until after follow-up
- High medical risk from uncontrolled diseases, infections, or comorbidities
- Conditions causing prolonged QT interval or history of dangerous heart rhythms
- Unstable heart disease or uncontrolled hypertension
- Significant mental illness or substance abuse that risks noncompliance
- Rapidly progressing AML/MDS or high risk for intensive chemotherapy within 3 months
- Life-threatening illness or severe organ dysfunction affecting safety or study completion
- Untreated CNS metastases; treated metastases must be stable for at least 4 weeks
- HIV infection
- Active hepatitis C infection (HCV+ with positive RNA PCR)
- Active hepatitis B infection (HBsAg+)
- Excessive alcohol consumption (over 24 units/week for males, 17 units/week for females)
- Recent blood donation or loss over 500 mL within 60 days before first dose
- Allergy to decitabine, cedazuridine, or their ingredients
AI-Screening
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Trial Site Locations
Total: 22 locations
1
MD Anderson
Houston, Texas, United States, 77030
Actively Recruiting
2
Erebuni Medical Center
Yerevan, Armenia
Actively Recruiting
3
Hematology Center After Prof. R. Yeolyan (Adult Blood Disorders)
Yerevan, Armenia
Actively Recruiting
4
Hematology Center After Prof. R. Yeolyan (Clinic of Adults Oncology)
Yerevan, Armenia
Actively Recruiting
5
National Center of Oncology Named After V.A. Fanarjyan
Yerevan, Armenia
Actively Recruiting
6
Complex Oncology Center - Plovdiv - Base II
Plovdiv, Bulgaria
Withdrawn
7
BIO1
Vilnius, Lithuania
Withdrawn
8
Centrum Badań Klinicznych Piotr Napora Lekarze Sp. p.
Wroclaw, Poland, 51-162
Actively Recruiting
9
Institutul Oncologic Bucuresti - Prof. Dr. Alexandru Trestioreanu
Bucharest, Romania, 22328
Actively Recruiting
10
Institutul Oncologic Prof. Dr. Ion Chiricuta
Cluj-Napoca, Romania, 400015
Actively Recruiting
11
Summit Clinical Research s.r.o
Bratislava, Slovakia, 831 01
Actively Recruiting
12
START Barcelona - Hospital HM Nou Delfos
Barcelona, Spain, 8023
Actively Recruiting
13
Hospital Universitari Dexeus - Grupo Quirónsalud
Barcelona, Spain
Withdrawn
14
START Rioja - Hospital de San Pedro
La Rioja, Spain, 26006
Not Yet Recruiting
15
Hospital Universitari Arnau de Vilanova
Lleida, Spain
Actively Recruiting
16
START Madrid - Hospital Universitario Fundación Jiménez Díaz
Madrid, Spain, 28040
Actively Recruiting
17
Hospital Universitario La Paz
Madrid, Spain, 28046
Actively Recruiting
18
START Madrid - CIOCC - HM Sanchinarro
Madrid, Spain, 28050
Actively Recruiting
19
Hospital Universitario 12 de Octubre
Madrid, Spain
Withdrawn
20
Hospital Clínico Universitario Virgen de la Arrixaca (Hematology Dept)
Murcia, Spain, 30120
Actively Recruiting
21
Hospital Clínico Universitario Virgen de la Arrixaca (Solid Tumor Dept)
Murcia, Spain
Actively Recruiting
22
Hospital Universitari i Politècnic La Fe
Valencia, Spain
Terminated
Research Team
T
Taiho Oncology, Inc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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