🏛️ Verified NIH Record • Updated 2026-05-27

Study to Evaluate the Pharmacokinetics and Safety of Oral Decitabine and Cedazuridine in Cancer Patients With Renal Impairment (NCT04953897)

🟢 Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: Taiho Oncology, Inc.

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (26 items) and avoid the listed exclusions (24 items).

Location: MD Anderson — Houston, Texas

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Treatment with azacitidine or decitabine within 4 weeks before Screening. Prior cytotoxic chemotherapy for AML except for hydroxyurea to control high white blood cell (WBC) counts.
  • Hospitalization for more than 2 days for documented febrile neutropenia, pneumonia, sepsis, or systemic infection 30 days prior to first dose.
  • 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, or ongoing clinically significant adverse events from previous treatment.
  • 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. Hematopoietic growth factors will not be routinely used unless cleared by Taiho medical expert.
  • Administration of live (attenuated) vaccines within 4 weeks before the first administration of oral decitabine and cedazuridine until after the follow-up visit. Other vaccines, e.g., inactivated or ribonucleic acid (RNA)-based, may be administered but should not occur from 7 days before first administration of oral decitabine and cedazuridine until after the follow-up visit.
  • High medical risk because of other conditions such as uncontrolled systemic diseases, active uncontrolled infections, or comorbidities that may put the participants at risk of not being able to complete 1 cycle of treatment.
  • Conditions which likely promote delayed ventricular repolarization (QT prolongation):
  • Corrected QT interval (QTc) using Fridericia's correction (QTcF) at Screening or Day -1 \>470 milliseconds (ms) for males and \>480 ms for females or
  • History or disposition for torsades des pointes (TdP) (e.g., heart failure, hypokalemia, family history of long QT Syndrome) or
  • Concomitant medications that prolong the QT/QTc interval
  • Cardiac abnormalities or unstable cardiovascular conditions:

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (21 Sites)

  • MD Anderson — Houston, Texas
  • Erebuni Medical Center — Yerevan,
  • Hematology Center After Prof. R. Yeolyan (Adult Blood Disorders) — Yerevan,
  • Hematology Center After Prof. R. Yeolyan (Clinic of Adults Oncology) — Yerevan,
  • National Center of Oncology Named After V.A. Fanarjyan — Yerevan,
  • Complex Oncology Center - Plovdiv - Base II — Plovdiv,
  • BIO1 — Vilnius,
  • Centrum Badań Klinicznych Piotr Napora Lekarze Sp. p. — Wroclaw,
  • Institutul Oncologic Bucuresti - Prof. Dr. Alexandru Trestioreanu — Bucharest,
  • Institutul Oncologic Prof. Dr. Ion Chiricuta — Cluj-Napoca,
  • Summit Clinical Research s.r.o — Bratislava,
  • START Barcelona - Hospital HM Nou Delfos — Barcelona,
  • Hospital Universitari Dexeus - Grupo Quirónsalud — Barcelona,
  • START Rioja - Hospital de San Pedro — La Rioja,
  • Hospital Universitari Arnau de Vilanova — Lleida,
  • START Madrid - Hospital Universitario Fundación Jiménez Díaz — Madrid,
  • START Madrid - CIOCC - HM Sanchinarro — Madrid,
  • Hospital Universitario 12 de Octubre — Madrid,
  • Hospital Clínico Universitario Virgen de la Arrixaca (Hematology Dept) — Murcia,
  • Hospital Clínico Universitario Virgen de la Arrixaca (Solid Tumor Dept) — Murcia,
  • Hospital Universitari i Politècnic La Fe — Valencia,

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
🏛️ View Official NIH Record ↗