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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario Hm Sanchinarro Madrid Spain

Other Sites

Site Name City Country Status
Staedtisches Klinikum Braunschweig gGmbH Brunswick Germany
Hospital Universitario 12 De Octubre Madrid Spain
Complex Oncological Center Plovdiv EOOD Plovdiv Bulgaria
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti Bucharest Romania
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
University Of Debrecen Debrecen Hungary
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida Lleida Spain
Centrum Badan Klinicznych Piotr Napora Lekarze sp.p. Wroclaw Poland
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
Klinik Hietzing Vienna Austria
Hospital Hm Nou Delfos Barcelona Spain
Summit Clinical Research s.r.o. Nove Mesto Slovakia
Specialized Hospital For Active Treatment Of Hematological Diseases EAD Sofia Bulgaria
Uswdbapnyctuot Cxlnuuq Klwwpfxlh Gdansk Poland
Fxzpmmycr Pouw Lv Insdhxpazaoql Bipcnmvsd Did Hocgzphm Uzmymnyygusjp Lw Pjo Madrid Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
01.06.2021
Bulgaria Bulgaria
Recruiting
01.06.2021
Germany Germany
Not recruiting
01.06.2021
Hungary Hungary
Recruiting
01.06.2021
Poland Poland
Not yet recruiting
01.06.2021
Romania Romania
Recruiting
01.06.2021
Slovakia Slovakia
Recruiting
01.06.2021
Spain Spain
Recruiting
01.06.2021

Trial locations

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.

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 ID:
2024-516293-29-01
Protocol code:
ASTX727-06
Trial Phase:
Therapeutic exploratory (Phase II)

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