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Study to Evaluate the Pharmacokinetics and Safety of Oral Decitabine and Cedazuridine in Cancer Patients With Renal Impairment | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

NCT04953897•Taiho Oncology, Inc.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+17 more criteria

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
+13 more criteria

Locations (21)

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

Key Dates

Start Date

December 15, 2021

Primary Completion Date

December 1, 2026

Completion Date

December 1, 2026

Last Updated

March 10, 2026

Enrollment

ESTIMATED participants

Conditions

Acute Myeloid LeukemiaMyelodysplastic Syndromes

Interventions

ASTX727

DRUG

Contacts

Taiho Oncology, Inc.

CONTACT

+1 844-878-2446 medicalinformation@taihooncology.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 10, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Phase I Study of HC-7366 for Acute Myeloid Leukemia

VAC Regimen for AML Patients Who Failed to Response to VA Regimen

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