OncoMatch/Clinical Trials/NCT04953910
Study to Evaluate the Pharmacokinetics and Safety of Oral Decitabine and Cedazuridine in Cancer Patients With Hepatic Impairment
Is NCT04953910 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies ASTX727 for acute myeloid leukemia.
Treatment: ASTX727 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Performance status
ECOG 0–3(Limited self-care)
Prior therapy
Cannot have received: azacitidine (azacitidine)
Treatment with azacitidine or decitabine within 4 weeks before screening
Cannot have received: decitabine (decitabine)
Treatment with azacitidine or decitabine within 4 weeks before screening
Cannot have received: cytotoxic chemotherapy
Exception: hydroxyurea to control high white blood cell (WBC) counts
Prior cytotoxic chemotherapy for AML except for hydroxyurea to control high white blood cell (WBC) counts
Cannot have received: investigational medicinal product
Treatment with any investigational medicinal product (IMP), investigational therapy, chemotherapy, immunotherapy, or targeted therapy within 2 weeks or 5 half-lives, whichever is longer, before the first dose of study treatment
Cannot have received: chemotherapy
Treatment with any investigational medicinal product (IMP), investigational therapy, chemotherapy, immunotherapy, or targeted therapy within 2 weeks or 5 half-lives, whichever is longer, before the first dose of study treatment
Cannot have received: immunotherapy
Treatment with any investigational medicinal product (IMP), investigational therapy, chemotherapy, immunotherapy, or targeted therapy within 2 weeks or 5 half-lives, whichever is longer, before the first dose of study treatment
Cannot have received: targeted therapy
Treatment with any investigational medicinal product (IMP), investigational therapy, chemotherapy, immunotherapy, or targeted therapy within 2 weeks or 5 half-lives, whichever is longer, before the first dose of study treatment
Cannot have received: MDS therapy (lenalidomide, erythropoietin, cyclosporine, tacrolimus, granulocyte-colony-stimulating factor, granulocyte-macrophage colony-stimulating factor)
Exception: prior treatment permitted if completed at least 1 week before first dose; short-term G-CSF for febrile neutropenia permitted at physician discretion
Concurrent MDS therapies, including lenalidomide, erythropoietin, cyclosporine/tacrolimus, granulocyte-colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor, etc. Prior treatment with these agents is permitted, provided that completion is at least 1 week before the first dose of study treatment. Short-term use of G-CSF for febrile neutropenia is permitted at the discretion of the treating physician and should be guided by accepted practice or institutional guidelines.
Lab requirements
Blood counts
For AML/MDS: Platelet count ≥25,000/μL; ANC ≥100/μL. For other hematologic malignancies or solid tumors: Platelet count ≥100,000/μL; ANC ≥1000/μL.
Kidney function
Creatinine clearance (CLcr) >50 mL/min according to Cockcroft-Gault equation
Liver function
Hepatic function defined per NCI CTEP ODWG: Group A (normal): total bilirubin ≤1× ULN; AST ≤1× ULN. Group B (moderate impairment): total bilirubin >1.5 to 3 × ULN; AST any value. Group C (severe impairment): total bilirubin >3 × ULN; AST any value.
Cardiac function
QTcF at screening or Day -1 >470 ms for males and >480 ms for females excluded; history/disposition for torsades des pointes (TdP) excluded; unstable ischemic heart disease or severe heart failure (NYHA III/IV) excluded; uncontrolled hypertension (SBP ≥180 mmHg and/or DBP ≥110 mmHg), hypotension (SBP <90 mmHg and/or DBP <50 mmHg) excluded.
Hepatic function defined per the National Cancer Institute Cancer Therapy Evaluation Program (NCI CTEP) Organ Dysfunction Working Group (ODWG)... Adequate renal function defined as creatinine clearance (CLcr, >50 mL/min according to the Cockcroft-Gault equation)... Platelet count and ANC requirements... QTcF at screening or Day -1 >470 ms for males and >480 ms for females excluded; history or disposition for torsades des pointes (TdP)... Cardiac abnormalities or unstable cardiovascular conditions excluded.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- MD Anderson · Houston, Texas
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