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Blood cancer drug ASTX727 gets extended trial for ongoing patients

NCT ID NCT04093570

Disease control Sponsor: Taiho Oncology, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 29, 2026 · Updated 2 times

Summary

This study offers continued treatment with the drug ASTX727 to adults with acute myeloid leukemia, chronic myelomonocytic leukemia, or myelodysplastic syndromes who were already benefiting from it in earlier studies. The main goal is to monitor long-term safety. About 332 participants will be enrolled by invitation only.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 332 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2019

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria for the Main Extension Study: Participants must fulfill all of the following inclusion criteria: 1. Previous participation in a Taiho (formerly Astex)-sponsored ASTX727 clinical trial (including, but not limited to studies ASTX727-01, ASTX727-02, and ASTX727-04, , ASTX727-17, and ASTX727-18, and the food effect substudy of ASTX727-06) in which the participant was treated with ASTX727 and was still on active treatment with ASTX727 at the time of study completion as determined by Taiho. 2. Participant is considered to be benefitting from ASTX727 treatment in the opinion of the treating investigator at the time of parent study completion (Participants must not be withdrawn from the parent study until eligibility for this study is confirmed). 3. Participant is able to understand and comply with the study procedures and understands the risks involved in the study. 4. Participant provides legally effective informed consent before undergoing any study-specific procedure. 5. Women of childbearing potential 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 methods of birth control during the study and for 6 months after the last dose of study treatment, agree not to donate eggs for the purpose of reproduction during this period and must agree not to become pregnant for 6 months after completing treatment; men with female partners of childbearing potential must agree to practice 2 highly effective contraceptive measures and must agree not to father a child while receiving ASTX727 and for at least 3 months after completing ASTX727 treatment. Inclusion Criteria for the Food Effect Substudy: 1. Participants must have a confirmed diagnosis of- i. Myelodysplastic syndromes (MDS) including all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, chronic myelomonocytic leukemia \[CMML\])), and participants with MDS International Prognostic Scoring System (IPSS) int-1, int-2, or high-risk MD. ii. Acute myeloid leukemia (AML), as diagnosed according to the 2016 World Health Organization (WHO) guidelines on acute leukemia, of any subtype except M3 (acute promyelocytic leukemia), who are not candidates for intensive chemotherapy, including participants receiving hypomethylating agent (HMA) treatment, who have a confirmed diagnosis and a prior confirmatory bone marrow report. Participants who are currently receiving HMA treatment must complete the ongoing (at the time of Screening) treatment cycle before enrolling in this study; timing of start of treatment cycle with ASTX727 is at the principal investigator's discretion. 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 3. Adequate organ function defined as follows: 1. Hepatic: Total bilirubin ≤1.5 × upper limit of normal (ULN); aspartate aminotransferase/serum glutamic-oxaloacetic transaminase (AST/SGOT) and alanine aminotransferase/serum glutamic-pyruvic transaminase (ALT/SGPT) ≤5 × ULN. 2. Renal: Calculated creatinine clearance ≥60 mL/min. Exclusion Criterion for the Main Extension Study: 1\. Any participant who, in the opinion of the investigator, may have other conditions, organ dysfunction, or for whom safety data from parent study participation suggests the risks of continuing treatment with ASTX727 may outweigh the benefits. Exclusion Criteria for the Food Effect Substudy: 1. Participants with known or suspected hypersensitivity to decitabine, cedazuridine, or any of the excipients in the ASTX727 tablets. 2. Poor medical risk because of other conditions such as uncontrolled systemic diseases or active uncontrolled infections. 3. Life-threatening illness, medical condition or organ system dysfunction, or other reasons including laboratory abnormalities, which, in the Investigator's opinion, could compromise the participant's safety, interfere with the absorption or metabolism of decitabine + cedazuridine or compromise the integrity of the study outcomes. 4. Prior gastric surgery for ulcer disease, weight loss, etc, that would impair normal motility or absorption. 5. Second malignancy currently requiring active chemotherapy. To clarify, participants with breast or prostate cancer stable on or responding to endocrine therapy, are eligible. 6. Known history of human immunodeficiency virus or known seropositive for hepatitis C virus or hepatitis B virus. 7. Active uncontrolled gastric or duodenal ulcer. 8. Participants with acute promyelocytic leukemia. 9. Prior cytotoxic chemotherapy for AML except for hydroxyurea to control high white blood cell (WBC) counts. 10. Treated with any investigational drug or therapy within 2 weeks of study treatment, or 5 half-lives, whichever is longer, before the protocol-defined first dose of study treatment, or ongoing clinically significant AEs from previous treatment with investigational drug or therapy.

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia chronic myelomonocytic leukemia myelodysplastic syndrome Myelodysplastic Syndromes

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute myeloid leukemia Chronic myelomonocytic leukemia Myelodysplastic syndromes

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    47 sites in 13 countries. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Baylor Scott White University Medical Center

    Dallas, Texas, 75246, United States

  • Boca Raton Clinical Research

    Plantation, Florida, 33322, United States

  • Cancer and Hematology Centers for Western Michigan

    Grand Rapids, Michigan, 49503, United States

  • Centrum Badań Klinicznych Piotr Napora Lekarze Sp. p.

    Wroclaw, Lower Silesian Voivodeship, Poland

  • Charleston Hematology Oncology Associates

    Charleston, South Carolina, 29414, United States

  • Clínica Universidad de Navarra - Madrid

    Madrid, 28027, Spain

  • Compassionate Care Research Group

    Fountain Valley, California, 92708, United States

  • Debreceni Egyetem Klinikai Kozpont, Belgyogyszati Klinika, B epulet, Hematologia

    Debrecen, 4032, Hungary

  • Erebuni Medical Center

    Yerevan, Armenia

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    Milan, 20122, Italy

  • Gabrail Cancer Center Research

    Canton, Ohio, 44718, United States

  • Gabrail Cancer Center Research - 06 FE Study

    Canton, Ohio, 44718, United States

  • Hackensack Medical Center

    Hackensack, New Jersey, 07601, United States

  • Hackensack Medical Center - 06 FE Study

    Hackensack, New Jersey, 07601, United States

  • Hematology Center After Prof. R. Yeolyan (Adult Blood Disorders)

    Yerevan, Armenia

  • Hematology Center After Prof. R. Yeolyan (Clinic of Adults Oncology)

    Yerevan, Armenia

  • Hospital Clínico Universitario Virgen de la Arrixaca

    Murcia, 30120, Spain

  • Hospital Universitari Arnau de Vilanova

    Lleida, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario La Fe

    Valencia, 46026, Spain

  • Hôpital Emile Muller

    Mulhouse, Grand Est, 68100, France

  • Institutul Oncologic Bucuresti - Prof. Dr. Alexandru Trestioreanu

    Bucharest, 22328, Romania

  • Institutul Oncologic Prof. Dr. Ion Chiricuta

    Cluj-Napoca, 400015, Romania

  • Kadlec Clinic Hematology and Oncology

    Kennewick, Washington, 99336, United States

  • May Cancer Center

    San Antonio, Texas, 78229, United States

  • Mayo - Rochester

    Rochester, Minnesota, 55905, United States

  • National Center of Oncology Named After V.A. Fanarjyan

    Yerevan, Armenia

  • Oregon Health and Science University

    Portland, Oregon, 92739, United States

  • Princess Margaret Cancer Center

    Toronto, M5G 2M9, Canada

  • QEII Health Sciences Centre

    Nova Scotia, B3H 2Y9, Canada

  • Rosewell Park Cancer Institute

    Buffalo, New York, 14263, United States

  • Roswell Park Cancer Institute - 06 FE Study

    Buffalo, New York, 14263, United States

  • Seattle Cancer Care Alliance/Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109, United States

  • Specialized Hospital for Active Treatment of Hematological Disease EAD

    Sofia, 1797, Bulgaria

  • Städtisches Klinikum Braunschweig

    Braunschweig, Lower Saxony, 38114, Germany

  • Summit Clinical Research s.r.o

    Bratislava, 83101, Slovakia

  • Sunnybrook Health Sciences Centre

    Toronto, M4N 3M5, Canada

  • The Ottawa Hosptial

    Ottawa, K1H 8L6, Canada

  • The Sidney Kimmel Comprehensive Cancer Center at John Hopkins

    Baltimore, Maryland, 21231, United States

  • The University of Chicago Medical Center

    Chicago, Illinois, 60637, United States

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • University of Alberta Hospital

    Edmonton, T6G 2B7, Canada

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • Universitätsklinikum Schleswig-Holstein - Campus Lübeck

    Lübeck, Schleswig-Holstein, 23538, Germany

  • Vanderbilt - Ingram Cancer Center

    Nashville, Tennessee, 37232, United States

  • Wiener Gesundheitsverbund - Klinik Hietzing 06 FE Study

    Vienna, 1130, Austria

  • Wiener Gesundheitsverbund - Klinik Hietzing 06 Study

    Vienna, 1130, Austria

More trials for these conditions

Other studies related to the condition(s) this trial covers.