A Study for Participants Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose)
This study is a continuation for people currently benefitting from a medicine called ASTX727 in other clinical trials. It focuses on blood cancers including acute myeloid leukaemia, chronic myelomonocytic leukaemia, and myelodysplastic syndromes. The main goal is to allow participants to keep receiving this helpful treatment. Researchers want to gather long-term information about how safe the medicine is. A smaller, completed part of the study also looked at how food affects the medicine's absorption. If you're already in certain ASTX727 studies and it's working for you, your doctor might discuss if you can join this extension study to continue your treatment journey.
At a glance
What is this study about?
This study is for individuals who have been taking a medicine called ASTX727 in a previous clinical trial for specific types of blood cancers, such as acute myeloid leukaemia, chronic myelomonocytic leukaemia, or myelodysplastic syndromes, and the treatment has been working well for them. It's like a 'continuation study' allowing you to keep receiving the ASTX727 if your doctor believes it's still benefiting you.
The main purpose of this study is to understand the long-term safety of ASTX727. Since you would have already been using the medicine, the doctors will continue to monitor your health closely to see how your body reacts to it over a longer period. This information is very important for learning more about how to best use ASTX727 in the future.
There was also a small, separate part of the study—now completed—that investigated how taking ASTX727 with or without food affects how your body absorbs the medicine. This kind of information helps doctors understand the best way for patients to take their medication, but it's important to remember this food-effect part of the study has finished.
Key takeaways
- This study is for continuing ASTX727 treatment if it's currently helping you.
- It aims to gather long-term safety information about ASTX727.
- You participate if you were in a previous ASTX727 study and benefiting.
- You'll attend regular clinic visits and take ASTX727 as before.
- The dose will usually be the same as your previous study.
- You can stop participating at any time.
Who may be eligible?
This study is for adults aged 18 and over who have been taking part in a previous clinical trial for ASTX727 and were still receiving and benefiting from the treatment when that trial ended. Your doctor must believe that ASTX727 is helping you. You also need to be able to understand what the study involves and sign a consent form showing you agree to take part.
If you are a woman who could become pregnant, you must not be pregnant or breastfeeding. You'll need to use highly effective birth control during the study and for six months afterwards. Men with female partners who could become pregnant also need to use effective birth control and should not try to father a child during the study and for three months after finishing treatment.
Basically, if you're already in an ASTX727 study and it's working well for you, your doctor might consider you for this extension study.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Have you been in a previous ASTX727 clinical trial?
- Was ASTX727 treatment helping you when that study finished?
- Does your doctor think ASTX727 is still benefiting you?
- Are you able to understand and agree to the study requirements?
- If you are a woman of childbearing age, are you willing to use effective birth control?
What does participation involve?
If you join this study, you will continue to take ASTX727 tablets. You’ll have clinic visits on the first day of each 28-day cycle. During these visits, the study team will carry out various checks and give you the medicine for the next few days. You will take the medicine home and take it for five days, followed by a break, just like in your previous study. The dose you take will generally be the same as you were already receiving.
Your doctor might need to adjust your dose or pause treatment if necessary, based on how you are feeling and responding. The study aims to follow you long-term, so there isn't a fixed end date for all participants; it depends on how you continue to benefit and tolerate the treatment. You will be closely monitored throughout your participation.
Potential risks and benefits
Locations (48)
- Compassionate Care Research GroupVerified postcodeFountain Valley, United States
- Boca Raton Clinical ResearchVerified postcodePlantation, United States
- The University of Chicago Medical CenterVerified postcodeChicago, United States
- The Sidney Kimmel Comprehensive Cancer Center at John HopkinsVerified postcodeBaltimore, United States
- Cancer and Hematology Centers for Western MichiganVerified postcodeGrand Rapids, United States
- Mayo - RochesterVerified postcodeRochester, United States
- Hackensack Medical Center - 06 FE StudyVerified postcodeHackensack, United States
- Hackensack Medical CenterVerified postcodeHackensack, United States
- Rosewell Park Cancer InstituteVerified postcodeBuffalo, United States
- Roswell Park Cancer Institute - 06 FE StudyVerified postcodeBuffalo, United States
- Gabrail Cancer Center Research - 06 FE StudyVerified postcodeCanton, United States
- Gabrail Cancer Center ResearchVerified postcodeCanton, United States
Common questions
What is the main reason for this study?
The main reason is to allow people who are already benefitting from ASTX727 in other studies to continue their treatment and for researchers to gather more information about the long-term safety of the medicine.
Who can join this study?
It's for adults (18+) who have previously received ASTX727 in another clinical study, were still taking it, and whose doctor thinks it's still helping their blood cancer.
What kind of conditions does ASTX727 treat in this study?
ASTX727 is being studied for blood cancers like acute myeloid leukaemia, chronic myelomonocytic leukaemia, and myelodysplastic syndromes.
Will I take the medicine differently in this study?
Generally, you will continue to take ASTX727 at the same dose and in the same way (5 days on, 23 days off in a 28-day cycle) as you did in your previous study.
What was the 'food effect substudy' mentioned?
That was a completed small part of the research looking at how eating different types of food affects how your body absorbs ASTX727. It's not part of the ongoing treatment in this main extension study.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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