Oral Decitabine and Cedazuridine for Cancer Patients with Liver Problems
This study is testing a combination of two oral drugs, decitabine and cedazuridine, in cancer patients with acute myeloid leukemia or myelodysplastic syndromes. We want to understand how these drugs are processed by the body (pharmacokinetics) and if they are safe for patients who also have liver problems (hepatic impairment). We are looking at how much of the drug stays in your body over 5 days. The study plans to enroll 27 adult participants, including those with moderate or severe liver problems, and those with normal liver function as a comparison group. Enrollment for patients with severe liver problems will only begin after we've checked the safety in patients with moderate liver problems. The current recruitment status is unclear.
- Study design
- This is an open-label study, meaning you and your doctors will know which treatment you are receiving. It is a Phase 1b study and plans to enroll 27 participants.
- What's involved
- You would need to be able to understand and follow study procedures, including a schedule of blood tests to measure drug levels during the first treatment cycle.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint measures drug levels over a 5-day period within one dosing interval. Further follow-up information is not specified.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT04953910
Study to Evaluate the Pharmacokinetics and Safety of Oral Decitabine and Cedazuridine in Cancer Patients With Hepatic Impairment
Recruiting
PHASE1Ages 18+InterventionalTreatmentTaiho Oncology, Inc.
~27 participants
Updated 2026-05-28 on ClinicalTrials.gov
What's tested:ASTX727
At a glance
Recruiting sites
17 of 22 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pharmacokinetic Parameter: 5-day Cumulative Area Under the Concentration-time Curve Within 1 Dosing Interval (AUCtau)
Measured over Predose and at multiple timepoints post-dose from Day 1 to Day 5
Conditions
Where it's being run
22 sites across 8 statesSpain11
Armenia4
Romania2
Texas1
Bulgaria1
Lithuania1
Poland1
Slovakia1
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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:
For participants with AML/MDS only:
For participants only with hematologic malignancies other than AML or MDS, or with solid tumors:
ECOG performance status of 0 to 3.
Hepatic function defined per the National Cancer Institute Cancer Therapy Evaluation Program (NCI CTEP) Organ Dysfunction Working Group (ODWG) as:
Adequate renal function defined as creatinine clearance (CLcr, \>50 mL/min according to the Cockcroft-Gault equation):
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 6months 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 and for at least 3 months after completing treatment.
Exclusion
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, erythropoietin, 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 participant at risk of not being able to complete 1 cycle of treatment.
Conditions which likely promote delayed ventricular repolarization (QT prolongation):
Cardiac abnormalities or unstable cardiovascular conditions:
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 participant 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 participant 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's opinion, could compromise the participant's 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).
Positive blood screen for hepatitis C antibody (HCV+) and positive RNA polymerase chain reaction (PCR). Participant can be included if HCV+ but negative for RNA PCR.
Positive blood screen for hepatitis B surface antigen (HBsAg+). Participants with positive blood screen for hepatitis B surface antibody (HBsAb+) and negative hepatitis B core antibody (HBcAb-) can be included if negative for hepatitis B surface antigen (HBsAg-).
Average intake of more than 24 units of alcohol per week for male participants and 17 units per week for female participant (1 unit of alcohol equals 10 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.
What this trial measures
- Pharmacokinetic Parameter: 5-day Cumulative Area Under the Concentration-time Curve Within 1 Dosing Interval (AUCtau)Predose and at multiple timepoints post-dose from Day 1 to Day 5
AUCtau from Day 1 to Day 5 for decitabine.