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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

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

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

Study to Evaluate the Pharmacokinetics and Safety of Oral Decitabine and Cedazuridine in Cancer Patients With Renal Impairment (NCT04953897) is a Phase 1 interventional studying Acute Myeloid Leukemia and Myelodysplastic Syndromes, sponsored by Taiho Oncology, Inc.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Acute Myeloid Leukemia, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 18 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - Able to understand and comply with the study procedures, understand the risks involved in the study, and provide legally effective willing to sign a consent form before the first study-specific procedure; specifically able to comply with the PK assessment schedule during the first treatment cycle. - Participants must have a diagnosed by tissue sample (biopsy-confirmed) malignancy as follows: 1. A solid tumor that is metastatic or unresectable and for which standard life-prolonging measures are not available. or 2. AML or MDS. or 3. A hematologic malignancy other than AML or MDS for which standard life-prolonging measures are not available. - For participants with AML/MDS only: 1. Cytologically or diagnosed by tissue sample (biopsy-confirmed) diagnosis of AML (except M3 acute promyelocytic leukemia) or MDS according to the 2008 World Health Organization (WHO) classification or 2. Participants with frontline MDS or treatment naïve AML not suitable for induction therapy (e.g., age \>75 years, Eastern Cooperative Oncology Group \[ECOG\] performance ≥2, severe pulmonary disorder, total bilirubin 1.5 × upper limit of normal \[ULN\]); or 3. Platelet count ≥25,000/per microliter (μL); or 4. Absolute neutrophil count (ANC) ≥100 cells/μL. - For participants with only hematologic malignancies other than AML or MDS, or solid tumors: 1. Platelet count ≥100,000/μL; and 2. white blood cell count (ANC) at least 1000 cells/μL. - You should be able to carry out daily activities with 0 level of ability (ECOG 0) to 3. - Adequate hepatic function defined as: 1. Total or direct bilirubin ≤1.5X upper limit of normal (ULN); and 2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5X ULN. - Participants must have a body surface area (BSA)-adjusted CLcr using to the Cockcroft-Gault equation: 1. Participants without renal impairment (Group B): ≥80 mL/min/1.73m\^²; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Able to understand and comply with the study procedures, understand the risks involved in the study, and provide legally effective informed consent before the first study-specific procedure; specifically able to comply with the PK assessment schedule during the first treatment cycle. * Participants must have a histologically or cytologically confirmed malignancy as follows: 1. A solid tumor that is metastatic or unresectable and for which standard life-prolonging measures are not available. or 2. AML or MDS. or 3. A hematologic malignancy other than AML or MDS for which standard life-prolonging measures are not available. * For participants with AML/MDS only: 1. Cytologically or histologically confirmed diagnosis of AML (except M3 acute promyelocytic leukemia) or MDS according to the 2008 World Health Organization (WHO) classification or 2. Participants with frontline MDS or treatment naïve AML not suitable for induction therapy (e.g., age \>75 years, Eastern Cooperative Oncology Group \[ECOG\] performance ≥2, severe pulmonary disorder, total bilirubin 1.5 × upper limit of normal \[ULN\]); or 3. Platelet count ≥25,000/per microliter (μL); or 4. Absolute neutrophil count (ANC) ≥100 cells/μL. * For participants with only hematologic malignancies other than AML or MDS, or solid tumors: 1. Platelet count ≥100,000/μL; and 2. ANC ≥1000 cells/μL. * ECOG performance status of 0 to 3. * Adequate hepatic function defined as: 1. Total or direct bilirubin ≤1.5X upper limit of normal (ULN); and 2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5X ULN. * Participants must have a body surface area (BSA)-adjusted CLcr using to the Cockcroft-Gault equation: 1. Participants without renal impairment (Group B): ≥80 mL/min/1.73m\^²; 2. Participants with severe renal impairment (Group A): \<30 mL/min/1.73m\^², not requiring dialysis; 3. CLcr must be stable with \<30% deviation allowed from screening to Day -1 (Baseline). Participants shifting outside the prospected renal function category (normal renal function or severe renal function) on Day-1 Baseline need to be agreed by Taiho medical expert whether they are allowed to remain in the original category that was assessed at screening. * No major surgery within 30 days of first administration of oral decitabine and cedazuridine. * Life expectancy of at least 3 months. * Women of childbearing potential (according to recommendations of the Clinical Trial Facilitation Group) must not be pregnant or breastfeeding and must have a negative pregnancy test at screening. * Women of childbearing potential must agree to practice 1 highly effective contraceptive measure of birth control with low user dependency and must agree not to become pregnant for 6 months after completing treatment. * Male participants with female partners of childbearing potential must agree to use a male condom and advise his partner to practice 1 highly effective contraceptive measure of birth control (user dependent or with low user dependency) and must agree not to father a child while receiving treatment with oral decitabine and cedazuridine for at least 3 months after completing treatment. 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): 1. 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 2. History or disposition for torsades des pointes (TdP) (e.g., heart failure, hypokalemia, family history of long QT Syndrome) or 3. Concomitant medications that prolong the QT/QTc interval * Cardiac abnormalities or unstable cardiovascular conditions: 1. Unstable ischemic heart disease or severe heart failure (New York Heart Association Class III or IV) or 2. Uncontrolled treated/untreated hypertension (defined as a mean of 3 repeated measurements for systolic blood pressure ≥ 180 millimeters of mercury (mmHg) and/or diastolic blood pressure ≥ 110 mmHg; current or documented history of repeated clinically significant hypotension or severe episodes of orthostatic hypotension (systolic blood pressure \<90 mmHg and/or diastolic blood pressure \<50 mmHg). * Known significant mental illness or other condition, such as active alcohol or other substance abuse or addiction, that in the opinion of the investigator predisposes the participants to high risk of noncompliance with the protocol. * In participants with AML/MDS, rapidly progressive or highly proliferative disease or other criteria that render the participants at high risk of requiring intensive cytotoxic chemotherapy within the next 3 months. * Life-threatening illness or severe organ system dysfunction, such as uncontrolled congestive heart failure or chronic obstructive pulmonary disease, or other reasons including laboratory abnormalities, that in the investigator opinion, could compromise the participant safety, interfere with the absorption or metabolism of oral decitabine and cedazuridine, or compromise completion of the study or integrity of the study outcomes. * Untreated central nervous system (CNS) metastases. Participants with treated CNS metastases are eligible provided they have been clinically stable for at least 4 weeks before screening. * Participants infected with human immunodeficiency virus (HIV). * Participants with active hepatitis B or hepatitis C infection. * History of alcohol abuse or drug addiction (including soft drugs like cannabis products). * Average intake of more than 24 units of alcohol per week for male participants and 17 units per week for female participants (1 unit of alcohol equals 10 milliliters (mL) of pure alcohol, i.e., approximately 250 mL of beer, 75 mL of wine or 25 mL of spirits). * Donation or loss of more than 500 mL of blood within 60 days prior to the first study drug administration. * Hypersensitivity to decitabine, cedazuridine, or any of the excipients in oral decitabine and cedazuridine.

Treatments Being Tested

DRUG

ASTX727

Multiple-dose oral administration of once-daily decitabine (35 mg) and cedazuridine (100 mg)

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

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

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT04953897), the sponsor (Taiho Oncology, Inc.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT04953897 clinical trial studying?

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 participan… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT04953897?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT04953897?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT04953897. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT04953897. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.