Study to Evaluate the Pharmacokinetics and Safety of Oral Decitabine and Cedazuridine in Cancer Patients With Renal Impairment (NCT04953897)
A Phase 1b, Open-label, Parallel Group, Multiple-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Oral Decitabine and Cedazuridine (ASTX727) in Cancer Patients With Severe Renal Impairment and Cancer Patients With Normal Renal Function
🩺 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: Review the eligibility criteria below.
Location: MD Anderson — Houston, Texas
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 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,
📞 Contact the Study Coordinator
Phone: (844) 878-2446
Email: medicalinformation@taihooncology.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.