OncoMatch/Clinical Trials/NCT04953897
Study to Evaluate the Pharmacokinetics and Safety of Oral Decitabine and Cedazuridine in Cancer Patients With Renal Impairment
Is NCT04953897 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, 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.
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: lenalidomide (lenalidomide)
Exception: prior treatment permitted if completed at least 1 week before first dose
Concurrent MDS therapies, including lenalidomide, 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.
Cannot have received: cyclosporine/tacrolimus (cyclosporine, tacrolimus)
Exception: prior treatment permitted if completed at least 1 week before first dose
Concurrent MDS therapies, including lenalidomide, 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.
Cannot have received: hematopoietic growth factor (granulocyte-colony-stimulating factor, granulocyte-macrophage colony-stimulating factor)
Exception: prior treatment permitted if completed at least 1 week before first dose; short-term use of G-CSF for febrile neutropenia permitted at physician discretion
Concurrent MDS therapies, including lenalidomide, 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 or ANC ≥100 cells/μL. For other hematologic malignancies or solid tumors: Platelet count ≥100,000/μL and ANC ≥1000 cells/μL.
Kidney function
BSA-adjusted CLcr using Cockcroft-Gault equation: Group B (no renal impairment): ≥80 mL/min/1.73m²; Group A (severe renal impairment): <30 mL/min/1.73m², not requiring dialysis; CLcr must be stable with <30% deviation allowed from screening to Day -1 (Baseline)
Liver function
Total or direct bilirubin ≤1.5X upper limit of normal (ULN); AST and ALT ≤2.5X ULN
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 Class III or IV) excluded; uncontrolled hypertension (SBP ≥180 mmHg and/or DBP ≥110 mmHg), hypotension (SBP <90 mmHg and/or DBP <50 mmHg) excluded
Adequate hepatic function defined as: Total or direct bilirubin ≤1.5X ULN; AST and ALT ≤2.5X ULN. ... Platelet count and ANC requirements as above. ... Conditions which likely promote delayed ventricular repolarization (QT prolongation): QTcF at Screening or Day -1 >470 ms for males and >480 ms for females or history/disposition for torsades des pointes (TdP) ... Cardiac abnormalities or unstable cardiovascular conditions: Unstable ischemic heart disease or severe heart failure (NYHA Class III or IV) or uncontrolled hypertension (SBP ≥180 mmHg and/or DBP ≥110 mmHg); ... hypotension (SBP <90 mmHg and/or DBP <50 mmHg).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- MD Anderson · Houston, Texas
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