Actively Recruiting
Study to Evaluate the Pharmacokinetics and Safety of Oral Decitabine and Cedazuridine in Cancer Patients With Renal Impairment
Led by Taiho Oncology, Inc. · Updated on 2026-04-30
18
Participants Needed
21
Research Sites
258 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study to Evaluate the Pharmacokinetics and Safety of Oral Decitabine and Cedazuridine in Cancer Patients With Renal Impairment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and comply with study procedures and provide informed consent
- Histologically or cytologically confirmed malignancy: metastatic or unresectable solid tumor without standard life-prolonging options, or AML, MDS, or other hematologic malignancy without standard life-prolonging options
- For AML/MDS: confirmed diagnosis except M3 acute promyelocytic leukemia, or frontline MDS/treatment-naive AML not suitable for induction therapy
- Platelet count ≥25,000/μL and absolute neutrophil count (ANC) ≥100 cells/μL for AML/MDS; platelet count ≥100,000/μL and ANC ≥1000 cells/μL for other hematologic malignancies or solid tumors
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 3
- Adequate liver function: total or direct bilirubin ≤1.5 times upper limit of normal (ULN); AST and ALT ≤2.5 times ULN
- Stable creatinine clearance (CLcr) by Cockcroft-Gault equation: ≥80 mL/min/1.73m² for normal renal function group or <30 mL/min/1.73m² for severe renal impairment group (without dialysis), with less than 30% deviation from screening to baseline
- No major surgery within 30 days before first dose
- Life expectancy of at least 3 months
- Women of childbearing potential must not be pregnant or breastfeeding and must have a negative pregnancy test
- Women of childbearing potential must agree to use highly effective contraception during and for 6 months after treatment
- Male participants with female partners of childbearing potential must use condoms and recommend contraception to partners during and for 3 months after treatment
You will not qualify if you...
- Treatment with azacitidine or decitabine within 4 weeks before screening
- Prior cytotoxic chemotherapy for AML except hydroxyurea for high white blood cell counts
- Hospitalization for febrile neutropenia, pneumonia, sepsis, or systemic infection longer than 2 days 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 treatments
- Concurrent myelodysplastic syndrome therapies unless completed at least 1 week before first dose
- Live vaccines within 4 weeks before first dose until after follow-up visit
- High medical risk due to uncontrolled systemic diseases or infections
- Conditions causing QT prolongation or history of torsades de pointes
- Unstable heart disease or severe heart failure, uncontrolled hypertension or significant hypotension
- Significant mental illness or substance abuse risking noncompliance
- Rapidly progressive or highly proliferative AML/MDS at high risk for intensive chemotherapy within 3 months
- Life-threatening illness or severe organ dysfunction compromising safety or study completion
- Untreated central nervous system metastases; treated metastases must be stable for at least 4 weeks
- Infection with HIV or active hepatitis B or C
- History of alcohol abuse or drug addiction
- Excessive alcohol consumption above specified weekly limits
- Blood donation or loss over 500 mL within 60 days before first dose
- Hypersensitivity to study drugs or excipients
AI-Screening
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Trial Site Locations
Total: 21 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
START Madrid - CIOCC - HM Sanchinarro
Madrid, Spain, 28050
Actively Recruiting
18
Hospital Universitario 12 de Octubre
Madrid, Spain
Withdrawn
19
Hospital Clínico Universitario Virgen de la Arrixaca (Hematology Dept)
Murcia, Spain, 30120
Actively Recruiting
20
Hospital Clínico Universitario Virgen de la Arrixaca (Solid Tumor Dept)
Murcia, Spain
Actively Recruiting
21
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
2
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