Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

RecruitingRare disease

Title: Long-term treatment study of oral decitabine and cedazuridine combination for patients with AML, MDS, CMML, or solid tumors who previously received ASTX727

Verified siteInvestigationalNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with blood disorders including Acute Myeloid Leukemia, Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia, and solid tumors. The study uses ASTX727, a medication that combines two substances: decitabine and cedazuridine. This medication comes in tablet form and is taken by mouth.

The purpose of this research is to gather long-term safety information about ASTX727 in patients who have already been using this medication in previous studies and have shown benefit from the treatment. The study will continue providing ASTX727 to these patients while monitoring their health and any effects of the medication.

During the study, participants will continue taking ASTX727 tablets according to their established treatment schedule. The maximum daily dose is 135 milligrams, and treatment may continue for up to 6 months. The research team will regularly check participants' health status and record any side effects that may occur during the treatment period.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial qualification

    Your eligibility for this study will be confirmed if you have previously participated in and benefited from treatment with ASTX727 in a prior clinical trial

    A pregnancy test will be required for women who can become pregnant

    You will need to review and sign an informed consent document before any study procedures begin

  2. Step 2

    Treatment phase

    You will receive ASTX727 tablets to take by mouth

    The treatment will continue as long as you are receiving benefit from the medication

    Regular monitoring of side effects will occur throughout the treatment period

  3. Step 3

    Birth control requirements

    Women who can become pregnant must use highly effective birth control during the study and for 6 months after the last dose

    Men with partners who can become pregnant must use condoms and their partners must use highly effective birth control during the study and for 3 months after the last dose

  4. Step 4

    Study duration

    The study is planned to continue until December 31, 2027

    Your participation in the study will depend on how well you respond to the treatment

  5. Step 5

    Safety monitoring

    The main focus will be monitoring any side effects you may experience during treatment

    Regular health assessments will be conducted throughout your participation

Who can join the trial?

12 criteria

  • Must have previously participated in an ASTX727 clinical trial and still be receiving active treatment with this medication
  • Must be currently benefiting from ASTX727 treatment according to the doctor's assessment
  • Must be able to understand and follow study procedures and understand the risks involved
  • Must provide informed consent before starting any study procedures
  • For women who can become pregnant:
    • Must not be pregnant or breastfeeding
    • Must have a negative pregnancy test at screening
    • Must use highly effective birth control during the study and for 6 months after the last dose
    • Must not donate eggs during the study and for 6 months after treatment
    • Must not try to become pregnant for 6 months after completing treatment
    • For men with female partners who can become pregnant:
      • Must use condoms during treatment and for 3 months after completing treatment
      • Must ensure their partner uses highly effective birth control during this period
      • Must not father a child during treatment and for 3 months after completing treatment

Who cannot join the trial?

10 criteria

  • Patients who have not previously participated in an Astex/Taiho sponsored clinical study with ASTX727 treatment
  • Patients who did not show benefit from previous ASTX727 treatment
  • Patients under 18 years of age
  • Pregnant or breastfeeding women
  • Patients who have experienced serious side effects during previous treatment with ASTX727
  • Patients who have withdrawn consent from previous clinical studies with ASTX727
  • Patients who are unable to take oral medications
  • Patients who have developed new serious medical conditions that would make participation unsafe
  • Patients who are participating in other clinical trials
  • Patients who have not completed the required follow-up period from their previous study
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

RecruitingNot recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

ASTX727 ASTX727 is a medication being studied for long-term treatment in patients who have previously shown benefits from using it in earlier clinical trials. This is an investigational drug that combines decitabine (a medication used to treat certain blood disorders) with cedazuridine (a substance that helps the body better absorb decitabine when taken by mouth). The medication is designed to be taken orally, making it more convenient for patients compared to traditional injectable treatments.

What is already known about the treatment

ASTX727 - An oral combination medication being investigated in clinical trials for the treatment of various blood cancers including acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and chronic myelomonocytic leukemia (CMML), as well as solid tumors. The medication is administered orally and represents a potential long-term treatment option for patients who have shown positive response in previous clinical studies. This investigational drug is being studied to evaluate its long-term safety profile and continued therapeutic benefits for patients who previously responded well to the treatment, though its exact molecular mechanism of action requires further research to be fully understood.

Investigated diseases

  • Acute Myeloid Leukemia (AML)

    A blood and bone marrow cancer that occurs when abnormal white blood cells accumulate in the bone marrow. These abnormal cells interfere with the production of normal blood cells. The disease develops rapidly, affecting the production of healthy blood cells.

  • Myelodysplastic Syndrome (MDS)

    A group of disorders where blood-forming cells in the bone marrow become abnormal and fail to produce enough healthy blood cells. The condition causes immature blood cells to fail to develop into healthy ones. The abnormal cells can build up in the bone marrow and blood.

  • Chronic Myelomonocytic Leukemia (CMML)

    A condition that affects blood-forming cells in the bone marrow, causing an increase in white blood cells called monocytes. It shares features of both myelodysplastic syndrome and myeloproliferative disorders. The disease typically develops slowly over time.

  • Solid Tumors

    Abnormal masses of tissue that usually do not contain cysts or liquid areas. They can occur in many parts of the body, including organs, muscles, and bones. Solid tumors form when cells divide and grow uncontrollably, forming a lump or mass.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516293-29-01Protocol codeASTX727-06Estimated enrolment371 patientsSponsorTaiho Oncology Inc.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.