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RecruitingNCT04256317Updated Oct 6, 2026

A Multi-phase Study of ASTX030 (Azacitidine and Cedazuridine) in Myeloid Neoplasm Alone or in Combination With Venetoclax in AML (AZTOUND Study)

A Phase 2/3 interventional study of Azacitidine and ASTX030 (cedazuridine + azacitidine) in Myelodysplastic Syndromes, Acute Myeloid Leukemia and Myelodysplastic Syndrome/Neoplasm, sponsored by Taiho Oncology, Inc.. Recruiting at 73 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-06.

Sponsored by Taiho Oncology, Inc. (part of Otsuka Holdings Co., Ltd.) · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Started May 2020; still recruiting 6 years 5 months later.
Updated Oct 6, 20262 sites addedGo to Updates ↓
Phase
Phase 2/3
Study type
Interventional
Enrollment
316
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Study ASTX030-01 is a multi-phase study comprising of Phases 1-3 Monotherapy arms, and Phase 1 and Phase 2 Combination Therapy arms. Phase 1 Monotherapy consists of an open-label Dose Escalation Stage (Stage A) using multiple cohorts at escalating dose levels of oral cedazuridine and azacitidine (only one study drug will be escalated at a time) followed by a Dose Expansion Stage (Stage B). Phase 2 Monotherapy is a randomized, open-label, crossover study to compare oral ASTX030 to subcutaneous (SC) azacitidine. Phase 3 Monotherapy is a randomized open-label crossover study comparing the final fixed dose of oral ASTX030 to SC azacitidine. Phase 1 Combination Therapy is an open-label, multicenter, randomized, exploratory study comparing ASTX030 and SC azacitidine in combination with venetoclax in participants with treatment-naïve AML. Phase 2 Combination Therapy is an open-label, single arm, study evaluating the efficacy, safety, pharmacokinetics (PK), and drug interactions of ASTX030 in combination with venetoclax in participants with treatment-naïve AML.

The duration of this multi-phase study is approximately 8 years.

Read the detailed description

The Phase 1 and Phase 2 Monotherapy arms have completed enrollment. The Phase 3 Monotherapy, Phase 1 Combination Therapy, and Phase 2 Combination Therapy arms are open for enrollment.

02

Conditions studied

  • Myelodysplastic Syndromes
  • Acute Myeloid Leukemia
  • Myelodysplastic Syndrome/Neoplasm
  • Chronic Myelomonocytic Leukemia

Keywords

  • ASTX030
  • Myeloid Neoplasm
  • Hematologic Disease
  • Leukemia
  • Acute Myeloid Leukemia (AML)
  • Myelodysplastic Syndrome (MDS)
  • Chronic Myelomonocytic Leukemia (CMML)
  • Vidaza™
  • Azacitidine
  • Azacitidine and cedazuridine drug combination
  • Venetoclax
  • Venclexta™
03

In context

Myelodysplastic Syndromes

1,997 studies on the registry are indexed under Myelodysplastic Syndromes; 324 are open to participants now.

This study's planned enrollment of 316 is above the median of 40 across 1,611 interventional studies indexed under Myelodysplastic Syndromes.

Browse Myelodysplastic Syndromes studies →

Lead sponsor

Taiho Oncology, Inc. is the lead sponsor of 66 studies on the registry; 9 are open to participants now.

Of its 25 completed or terminated interventional studies of FDA-regulated products, 13 (52%) have results posted.

Browse Taiho Oncology, Inc. studies →All Otsuka Holdings Co., Ltd. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Phase 2 Monotherapy:

    1. Has Confirmed MDS, CMML, or other MDS/MPN diagnosis who are candidates to receive and benefit from single agent azacitidine and as applicable according to local country approvals and/or local institution standard practice.

  • Phase 3 Monotherapy:

    1. Has confirmed MDS or CMML and is a candidate to receive and benefit from single agent azacitidine as applicable according to local country approvals and/or local institution standard practice:

      a) French-American-British myelodysplastic syndrome subtypes: anemia (RA) or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and CMML or MDS with intermediate-2 or high risk MDS according to the International Prognostic Scoring System (IPSS).

    2. (ECOG) performance status of 0 to 1.
    3. Participants with adequate organ function.
    4. For participants with prior stem cell transplant, no evidence of (GVHD).
    5. Participants with no major surgery within 3 weeks before first study treatment.
    6. Participants with no cytotoxic chemotherapy (excluding hydroxyurea) within 4 weeks before first study treatment.
    7. Is able to swallow the number of tablets/capsules required for the treatment assignment within a 10-minute period and tolerate 4 hours of fasting.
    8. Participants with projected of at least 12 weeks.

  • Phase 1 and Phase 2 Combination Therapy:

    1. Has histological confirmation of newly diagnosed AML by World Health Organization (WHO) 2022 criteria (Phase 1) or 2016 criteria (Phase 2).
    2. Participants with projected life expectancy of at least 12 weeks.

    3. Must be considered ineligible for intensive induction chemotherapy defined by the following:

      a. Aged 75 years or older, or b. Aged 18 to 74 years with at least one of the following comorbidities: i. Severe cardiac disorder (e.g., congestive heart failure requiring treatment, ≤50%, or chronic stable angina).

      ii. Severe pulmonary disorder (e.g., diffusing capacity of the lung for carbon monoxide (DLCO) ≤65% or [FEV1] ≤65%). iii. ≥30 mL/min to \<45 mL/min. iv. Moderate hepatic impairment with total >1.5 to ≤3.0 × (ULN).

      v. ECOG Performance Status of 2 or 3.

    4. Has an ECOG Performance Status of 0-2 for participants ≥75 years of age or 0-3 for participants 18 to 74 years of age.

Exclusion criteria

Exclusion Criteria:

  • All Monotherapy Phases:

    1. Has an active uncontrolled gastric or duodenal ulcer.
    2. Has poor medical risk because of other conditions.
    3. Has known (HIV) infection.
    4. Is known to be positive for or C infection.
    5. Has a life-threatening illness.
    6. Has a history of other prior to study entry, with the exception of adequately treated in situ carcinoma of the breast or cervix uteri; localized basal cell carcinoma or squamous cell carcinoma of the skin; previous malignancy confined and surgically resected or adequately treated and controlled with other modalities; and any early stage malignancy for which no definitive therapy is required.
    7. Participants with MDS/MPN including CMML who have clinical extramedullary disease including clinically palpable hepatomegaly or splenomegaly.
    8. Has previous treatment with more than 1 cycle of decitabine, azacitidine, or guadecitabine (Phases 2 and 3 only).
    9. Has been treated with any drug or therapy within 2 weeks, or 5 half-lives, whichever is longer, before the protocol-defined first dose of study treatment, or ongoing adverse events from previous treatment with investigational drug or therapy.
    10. Has a known or suspected to cedazuridine or azacitidine or any of their .
    11. Cannot discontinue treatment with any drugs that delay gastric emptying such as glucagon-like peptide-1 (GLP-1) and/or gastric inhibitory polypeptide (GIP) agonists in Cycles 1 and 2 of the study.
    12. Has a known or suspected hypersensitivity to cedazuridine or azacitidine or any of their excipients.

  • Phase 1 and Phase 2 Combination Therapy:

    1. Has a history of MPN including myelofibrosis, essential thrombocythemia, polycythemia vera, chronic myeloid leukemia with or without BCR-ABL1 translocation, or AML with BCR-ABL1 translocation.
    2. Has the following karyotype abnormalities: t(15;17) or other acute promyelocytic leukemia variants that remain sensitive to all-trans retinoic acid (ATRA) therapy [t(8;21) and inv(16) are excluded in Phase 2 only].
    3. Has known active central nervous system involvement from AML.
    4. Has known human immunodeficiency virus (HIV) infection.
    5. Is known to be positive for Hepatitis B or C infection.
    6. Has severe hepatic impairment
    7. Has severe renal impairment
    8. Has a malabsorption syndrome or other condition that precludes enteral route of administration.
    9. Has a cardiovascular disability status of Class >2.
    10. Has significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, cardiovascular, or pulmonary disease; or any other medical condition that in the opinion of the investigator would adversely affect his/her participation in this study.
    11. Has clinically significant uncontrolled systemic infection requiring therapy (viral, bacterial, or fungal).
    12. Has a history of other malignancies prior to study entry with the exception of adequately treated in situ carcinoma of the breast or cervix uteri; localized basal cell carcinoma or squamous cell carcinoma of the skin; previous malignancy confined and surgically resected (or adequately treated and controlled with other modalities); and any early stage malignancy for which no definitive therapy is required.
    13. Has a WBC count >25,000/ microliters (μL) (hydroxyurea treatment is permitted to meet this criterion).

    14. Has received treatment with any of the following:

      1. A hypomethylating agent (azacitidine or decitabine) or venetoclax, including prior treatment for MDS.
      2. Chimeric Antigen Receptor (CAR)-T cell therapy.
      3. Investigational therapies for MDS or AML.

    15. Cannot discontinue treatment with any of the following:

      1. Prophylactic antifungal therapy with inhibitor activity or other concomitant medications with moderate or strong CYP3A inhibitor activity ≥7 days or 5 halflives, whichever is greater, prior to Cycle 1 Day 1 (C1D1).
      2. Drugs that are strong CYP3A or P-gp inhibitors ≥7 days or 5 half-lives, whichever is greater, prior to C1D1.
    16. Cannot avoid concomitant drugs known as moderate or strong CYP3A inducers.
    17. Cannot discontinue treatment with any drugs that delay gastric emptying such as GLP-1 and/or GIP agonists in Cycles 1 and 2 of the study.
    18. Is participating in another research study requiring interventions such as drug therapy or study procedures.
    19. Has a known or suspected hypersensitivity to cedazuridine, azacitidine, venetoclax, or any of their excipients.
    20. Has known significant mental illness or other conditions such as alcohol or other substance abuse or addictions
    21. Consumes grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or starfruit ≤7 days prior to C1D1.
Terms in these criteria, in plain language(19)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

GVHD (graft-versus-host disease)

After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
316 participants (estimated)

Study arms

  • Experimental
    Phase 1 Monotherapy , Stage A (Dose Escalation)

    In Cycle 1 (28 days per cycle), single dose oral azacitidine will be administered, followed by SC azacitidine, ASTX030 and oral cedazuridine on a specific dosing schedule; in Cycle 2, oral ASTX030 (cedazuridine + azacitidine) will be administered.

    Drug: Azacitidine · Drug: ASTX030 (cedazuridine + azacitidine) · Drug: Cedazuridine

  • Experimental
    Phase 1 Monotherapy, Stage B (Dose Expansion)

    In Cycle 1 (28 days per cycle), single dose oral azacitidine will be administered, followed by SC azacitidine, ASTX030 and oral cedazuridine on a specific dosing schedule; in Cycle 2, oral ASTX030 (cedazuridine + azacitidine) will be administered. On Day 7 of Cycle 2 drug products will administered in a fed state and all other doses will be administered in fasted state.

    Drug: Azacitidine · Drug: ASTX030 (cedazuridine + azacitidine) · Drug: Cedazuridine

  • Experimental
    Phase 2 Monotherapy, Part B, Sequence A & B

    In Sequence A: Oral ASTX030 (cedazuridine + azacitidine) will be administered in Cycle 1, followed by SC azacitidine in Cycle 2; all participants will receive ASTX030 in subsequent cycles (Cycles ≥3). In Sequence B: SC azacitidine will be administered in Cycle 1, followed by oral cedazuridine + azacitidine tablets/capsules in Cycle 2; all participants will receive ASTX030 in subsequent cycles (Cycles ≥3).

    Drug: ASTX030 (cedazuridine + azacitidine) · Drug: Azacitidine

  • Experimental
    Phase 3 Monotherapy, Sequence A & B

    In Sequence A: Participants will receive ASTX030 in Cycle 1, followed by SC azacitidine in Cycle 2; all participants will receive ASTX030 in subsequent cycles (Cycles ≥3). In Sequence B: Participants will receive SC azacitidine in Cycle 1 followed by ASTX030 in Cycle 2; all participants will receive ASTX030 in subsequent cycles (Cycles ≥3).

    Drug: ASTX030 (cedazuridine + azacitidine) · Drug: Azacitidine

  • Experimental
    Phase 1 Combination Therapy

    Treatment Arm 1: Participants will receive oral dose of ASTX030 along with ramp-up oral dosing of venetoclax in Cycle 1 (cycle length = 28 days); participants will receive ASTX030 along with venetoclax on a specific dosing schedule in subsequent cycles (Cycles ≥2). Treatment Arm 2: Participants will receive SC azacitidine along with ramp-up oral dosing of venetoclax in Cycle 1 (cycle length = 28 days); participants will receive SC azacitidine along with oral dose of venetoclax on a specific dosing schedule in subsequent cycles (Cycles ≥2). At the beginning of Cycle 5, Arm 2 patients may be permitted to cross over to Arm 1.

    Drug: ASTX030 (cedazuridine + azacitidine) · Drug: Azacitidine · Drug: Venetoclax

  • Experimental
    Phase 2 Combination Therapy

    Participants will receive ASTX030 along with ramp-up oral dosing of venetoclax in Cycle 1 (cycle length = 28 days); participants will receive ASTX030 along with venetoclax on a specific dosing schedule in subsequent cycles (Cycles ≥2).

    Drug: ASTX030 (cedazuridine + azacitidine) · Drug: Venetoclax

Interventions

  • DrugAzacitidine

    Tablets/Capsules for oral administration and powder for reconstitution to aqueous suspension for SC administration.

    Also known as: Vidaza™ (powder only)

  • DrugASTX030 (cedazuridine + azacitidine)

    FDC Capsules for oral administration.

  • DrugAzacitidine

    Powder for reconstitution to aqueous suspension for SC administration.

    Also known as: Vidaza™ (powder only)

  • DrugASTX030 (cedazuridine + azacitidine)

    Tablets/Capsules for oral administration.

  • DrugCedazuridine

    Tablets for oral administration.

  • DrugVenetoclax

    Oral tablets.

    Also known as: Venclexta™

06

What researchers measure

Primary outcomes

  1. Phase 1, 2 and 3 Monotherapy: Total Cycle Area Under the Curve (AUC) From 0 to 24 Hours (AUC0-24) Exposures

    Ratio of azacitidine total cycle AUC0-24 exposures after oral ASTX030 over SC azacitidine.

    Time frame: Predose and at multiple timepoints post-dose up to 24 hours

  2. Phase 1 Combination Therapy: Number of Participants with Treatment-emergent Adverse Events (TEAEs)

    Time frame: Up to 24 months

  3. Phase 1 and 2 Combination Therapy: Complete Response (CR) Rate as Assessed by the Investigator

    Time frame: Up to 36 months

  4. Phase 1 Combination Therapy: AUC0-24 of Venetoclax With ASTX030

    Time frame: Pre-dose and at multiple timepoints post-dose up to 24 hours on Day 7 (with ASTX030] of Cycle 1

  5. Phase 1 Combination Therapy: AUC0-24 of Venetoclax Without ASTX030

    Time frame: Pre-dose and at multiple timepoints post-dose up to 24 hours on Day 14 (without ASTX030) of Cycle 1

  6. Phase 1 Combination Therapy: Maximum Plasma Concentration (Cmax) of Venetoclax With ASTX030

    Time frame: Pre-dose and at multiple timepoints post-dose up to 24 hours on Day 7 (with ASTX030] of Cycle 1

  7. Phase 1 Combination Therapy: Cmax of Venetoclax Without ASTX030

    Time frame: Pre-dose and at multiple timepoints post-dose up to 24 hours on Day 14 (without ASTX030) of Cycle 1

Secondary outcomes

  1. Phase 1, 2 and 3 Monotherapy: Number of Participants with Treatment-emergent Adverse Events (TEAEs)

    Time frame: Up to 36 months

  2. Phase 1, 2 and 3 Monotherapy: Change in Deoxyribonucleic Acid (DNA) Methylation

    Percent long interspersed nuclear elements 1 (LINE-1) methylation change (demethylation) from baseline in Cycle 1 (Phase 1) and compared between SC azacitidine and ASTX030 in Cycles 1 and 2 (Phase 2 and 3).

    Time frame: Baseline in Phase 1 to the end of Cycle 2 in Phase 3 (28 days per cycle)

  3. Phase 1, 2 and 3 Monotherapy: Best CR Rate in Participants with MDS, CMML, or MDS/Myeloproliferative Neoplasms (MPN)

    Time frame: Up to 36 months

  4. Phase 1, 2 and 3 Monotherapy: AML-free Survival for Participants with MDS, CMML, or MDS/MPN

    Number of days from the date of randomization (date of first treatment in Phase 1) to either the date of MDS, CMML, or MDS/MPN progression to AML or the date of death from any cause

    Time frame: Up to 36 months

  5. Phase 1, 2 and 3 Monotherapy: Duration of Response

    Number of days from the date that criteria are met for response until the first date that recurrent or progressive disease is documented by the investigating physician

    Time frame: Up to 36 months

  6. Phase 1, 2 and 3 Monotherapy: Overall Survival

    Number of days from the date the participant was randomized (date of first treatment in Phase 1) to the date of death, regardless of cause

    Time frame: Up to 36 months

  7. Phase 1, 2 and 3 Monotherapy: Time to Response

    Number of days from the start of treatment until the participant's first day of best response

    Time frame: Up to 36 months

  8. Phase 1, 2 and 3 Monotherapy: Red Blood Cell (RBC) Transfusion Independence (TI)

    Number of participants with RBC TI, defined as no RBC transfusion for 56 consecutive days while maintaining hemoglobin ≥8 g/dL

    Time frame: Up to 36 months

  9. Phase 1, 2 and 3 Monotherapy: Platelet Transfusion Independence (TI)

    Number of participants with platelet TI, defined as no platelet transfusion for 56 consecutive days while maintaining platelets ≥20×10\^9/L

    Time frame: Up to 36 months

  10. Phase 1, 2 and 3 Monotherapy: AUC of Azacitidine, Cedazuridine and Cedazuridine-epimer

    Time frame: Predose and at multiple timepoints post-dose on Days 1, 2 and 7 of Cycle 1 and Cycle 2 (cycle length=28 days)

  11. Phase 1, 2 and 3 Monotherapy: Cmax of Azacitidine, Cedazuridine and Cedazuridine-epimer

    Time frame: Predose and at multiple timepoints post-dose on Days 1, 2 and 7 of Cycle 1 and Cycle 2 (cycle length=28 days)

  12. Phase 1, 2 and 3 Monotherapy: Time to Reach Cmax (Tmax) of Azacitidine, Cedazuridine and Cedazuridine-epimer

    Time frame: Predose and at multiple timepoints post-dose on Days 1, 2 and 7 of Cycle 1 and Cycle 2 (cycle length=28 days)

  13. Phase 1B, Food Effect Cohort: AUC of Azacitidine, Cedazuridine and Cedazuridine-epimer

    Time frame: Predose and at multiple timepoints post-dose on Day 7 of Cycle 2 (cycle length=28 days)

  14. Phase 1B Monotherapy, Food Effect Cohort: Cmax of Azacitidine, Cedazuridine and Cedazuridine-epimer

    Time frame: Predose and at multiple timepoints post-dose on Day 7 of Cycle 2 (cycle length=28 days)

  15. Phase 1B Monotherapy, Food Effect Cohort: Tmax of Azacitidine, Cedazuridine and Cedazuridine-epimer

    Time frame: Predose and at multiple timepoints post-dose on Day 7 of Cycle 2 (cycle length=28 days)

  16. Phase 1 and 2 Combination Therapy: AUC0-24 of Azacitidine, Cedazuridine and Cedazuridine-epimer

    Time frame: Predose and at multiple timepoints post-dose up to 24 hours on Day 7 of Cycles 1 and 2 (cycle length = 28 days)

  17. Phase 1 and 2 Combination Therapy: Cmax of Azacitidine, Cedazuridine and Cedazuridine-epimer

    Time frame: Predose and at multiple timepoints post-dose on Day 7 of Cycles 1 and 2 (cycle length = 28 days)

  18. Phase 1 and 2 Combination Therapy: Tmax of Azacitidine, Cedazuridine and Cedazuridine-epimer

    Time frame: Predose and at multiple timepoints post-dose on Day 7 of Cycles 1 and 2 (cycle length = 28 days)

  19. Phase 1 and 2 Combination Therapy: AUC0-9 of Azacitidine, Cedazuridine and Cedazuridine-epimer

    Time frame: Predose and at multiple timepoints post-dose up to 9 hours on Day 7 of Cycles 1 and 2 (cycle length = 28 days)

  20. Phase 1 and 2 Combination Therapy: AUC0-inf of Azacitidine, Cedazuridine and Cedazuridine-epimer

    Time frame: Predose and at multiple timepoints post-dose on Day 7 of Cycles 1 and 2 (cycle length = 28 days)

  21. Phase 1 Combination Therapy: AUC of SC Azacitidine and Venetoclax

    Time frame: Predose and at multiple timepoints post-dose on Day 7 of Cycles 1 and 2 (cycle length = 28 days)

  22. Phase 1 Combination Therapy: AUC of Venetoclax, Azacitidine, and Cedazuridine

    Time frame: Predose and at multiple timepoints post-dose on Day 7 of Cycles 1 and 2 (cycle length = 28 days)

  23. Phase 1 Combination Therapy: Cmax of SC Azacitidine and Venetoclax

    Time frame: Predose and at multiple timepoints post-dose on Day 7 of Cycles 1 and 2 (cycle length = 28 days)

  24. Phase 1 Combination Therapy: Cmax of Venetoclax, Azacitidine, and Cedazuridine

    Time frame: Predose and at multiple timepoints post-dose on Day 7 of Cycles 1 and 2 (cycle length = 28 days)

  25. Phase 1 Combination Therapy: Tmax of Venetoclax, Azacitidine, and Cedazuridine

    Time frame: Predose and at multiple timepoints post-dose on Day 7 of Cycles 1 and 2 (cycle length = 28 days)

  26. Phase 1 and 2 Combination Therapy: CR and Complete Response with Partial Hematologic Recovery (CRh) Rate

    Time frame: Up to 36 months

  27. Phase 1 and 2 Combination Therapy: CR and Complete Response with Incomplete Hematologic Recovery (CRi) Rate

    Time frame: Up to 36 months

  28. Phase 1 and 2 Combination Therapy: Time to CR and CRh

    Time frame: Up to 36 months

  29. Phase 2 Combination Therapy: AUC0-24 of Venetoclax With and Without ASTX030

    Time frame: Pre-dose and at multiple timepoints post-dose up to 24 hours on Day 7 (with ASTX030] and Day 14 (without ASTX030) of Cycle 1

  30. Phase 2 Combination Therapy: Cmax of Venetoclax With and Without ASTX030

    Time frame: Time Frame: Pre-dose and at multiple timepoints post-dose up to 24 hours on Day 7 (with ASTX030] and Day 14 (without ASTX030) of Cycle 1

  31. Phase 2 Combination Therapy: Number of Participants with TEAEs

    Time frame: Up to 36 months

  32. Phase 2 Combination Therapy: Overall Survival (OS)

    Time frame: Up to 36 months

  33. Phase 2 Combination Therapy: Event Free Survival (EFS)

    Time frame: Up to 36 months

  34. Phase 2 Combination Therapy: Duration of CR and CRi or CRh

    Time frame: Up to 36 months

07

Study locations

65 of 73 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started May 2020 (actual). Primary completion is estimated for Nov 2027, 89 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 31, 2020
First posted
Feb 5, 2020
StartActual
May 21, 2020
Primary completionEst.
Nov 1, 2027
CompletionEst.
Nov 1, 2028
Last update
Oct 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
2 sites added
Show 2 added (2 United Kingdom)
  • Maidstone and Tunbridge Wells NHS Trust - Maidstone Hospital · Maidstone, United Kingdom
  • Oxford University Hospitals NHS Foundation Trust · Oxford, United Kingdom
Oct 6, 2026
Show all 1 update
  1. Oct 6, 2026
    2 sites added
    Show 2 added (2 United Kingdom)
    • Maidstone and Tunbridge Wells NHS Trust - Maidstone Hospital · Maidstone, United Kingdom
    • Oxford University Hospitals NHS Foundation Trust · Oxford, United Kingdom
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT04256317
Lead sponsor
Taiho Oncology, Inc.
Responsible party
Sponsor
First posted
Feb 5, 2020
Start date
May 21, 2020
Primary completion
Nov 1, 2027 (estimated)
Completion
Nov 1, 2028 (estimated)
Last update
Oct 6, 2026

Study contacts

Taiho Oncology, Inc.
Contact
medicalinformation@taihooncology.com
+1 844-878-2446

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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