RecruitingPHASE1, PHASE2INTERVENTIONAL

Study to Evaluate the Safety and Tolerability of EP0042

This research study is investigating a new medication, EP0042, for people with specific advanced blood cancers, including acute myeloid leukaemia (AML), chronic myelomonocytic leukaemia (CMML), and myelodysplastic syndromes (MDS). The main goal is to test different doses of EP0042, either by itself or with other established treatments like Venetoclax and Azacitidine, to identify a dose that is safe, well-tolerated, and shows promise in treating these conditions. This is a Phase 1 and Phase 2 study, meaning it's still in the early stages of testing in humans, focusing on safety and initial effectiveness. It's designed for patients aged 18 and over, particularly those whose previous treatments for these cancers have not been successful or are no longer an option.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Ellipses Pharma

Enrolment target

Start

02 Nov 2020

Estimated completion

01 Dec 2026

Acute Myeloid Leukemia Chronic Myelomonocytic Leukemia Myelodysplastic Syndromes

What is this study about?

Imagine your body has tiny factories called blood cells, and sometimes these factories don't work properly, leading to certain types of cancer like leukaemia or myelodysplastic syndromes. When this happens, doctors try different medicines to help. This study is testing a new medicine called EP0042 for people with advanced forms of these blood cancers, specifically Acute Myeloid Leukaemia (AML), Chronic Myelomonocytic Leukaemia (CMML), and Myelodysplastic Syndromes (MDS).

The main purpose of this study is to carefully look at EP0042 to find out how safe it is and how well people tolerate it at different doses. Researchers want to identify a dose that causes the fewest side effects while still being strong enough to potentially help treat the cancer. They might also test EP0042 alongside other treatments that doctors already use, like Venetoclax or Azacitidine, to see if they work better together.

This kind of study, called a Phase 1/Phase 2 trial, is an important step in developing new medicines. It means that while the drug has shown promise in earlier tests, it's now being tested in a larger group of people to understand its effects more thoroughly. It's for people whose cancers have either come back after treatment or haven't responded to other available medicines.

Key takeaways

This study explores a new drug, EP0042, for advanced blood cancers.
It's for people whose previous treatments weren't successful.
The main goals are to find a safe dose and see how well it works.
It could offer a new treatment option, but, like all studies, has potential risks.
Participation involves regular medical check-ups and taking the study medicine.
You can stop participating at any time.

Who may be eligible?

To be part of this study, you need to be at least 18 years old and have a confirmed diagnosis of Acute Myeloid Leukaemia (AML), Myelodysplastic Syndromes (MDS), or Chronic Myelomonocytic Leukaemia (CMML). Importantly, these are for people whose cancer hasn't responded well to previous treatments, or if those treatments are no longer suitable for them. You should also be well enough to manage daily activities, and your other health conditions should be stable.

You would need to be able to swallow tablets and be expected to live long enough to complete at least one 28-day cycle of treatment. Both men and women can participate, but if you're a woman who could become pregnant, or a man, you'd need to use effective contraception during and for a period after the study.

There are also reasons why you might not be able to join. For example, if you have certain brain tumours or other serious medical issues that the study doctors feel would make it unsafe for you to participate.

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 diagnosed with Acute Myeloid Leukaemia (AML), Chronic Myelomonocytic Leukaemia (CMML), or Myelodysplastic Syndromes (MDS)?
Have your previous cancer treatments not worked well, or are they no longer an option for you?
Are you generally well enough to go about your daily activities?
Can you swallow tablets without difficulty?
Are you able to use contraception if you could become pregnant or father a child?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study drug, EP0042, which will be swallowed as a tablet. You might also receive other approved medications for your condition, such as Venetoclax or Azacitidine, depending on which group you are in.

The study involves regular visits to the clinic for check-ups, which include blood tests, physical examinations, and possibly other tests to see how the treatment is working and to monitor your health. You'll need to answer questions about how you're feeling and any side effects you might experience.

Each treatment cycle lasts 28 days, and you would continue treatment for as long as it is helping you and you are tolerating it well. The total duration of your participation would depend on your individual response to the treatment, but the study will involve ongoing follow-up. You'll be given detailed information about the schedule of visits and what each visit entails if you are considering joining.

Potential risks and benefits

Taking part in any medical study has both potential benefits and risks. While EP0042 is an experimental drug, meaning its full effects are not yet known, it could offer a new treatment option for your specific cancer if previous treatments haven't worked. You would also receive close medical attention and monitoring throughout the study. However, like all medications, EP0042 may cause side effects, some of which could be serious. The research team will carefully explain all known and potential risks to you. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care or your relationship with your medical team. Your safety and well-being are the top priority.

Locations (6)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Royal Perth Hospital
Verified postcode
Perth, Australia· Recruiting
Amsterdam UMC
Verified postcode
Amsterdam, Netherlands· Recruiting
Erasmus MC
Verified postcode
Rotterdam, Netherlands· Recruiting
University College London Hospital
Verified postcode
London, United Kingdom· Recruiting
The Royal Marsden
Verified postcode
London, United Kingdom· Recruiting
The Christie Hospital
Verified postcode
Manchester, United Kingdom· Recruiting

Common questions

What kind of cancer is this study for?

This study is for people with advanced Acute Myeloid Leukaemia (AML), Chronic Myelomonocytic Leukaemia (CMML), or Myelodysplastic Syndromes (MDS).

What is EP0042?

EP0042 is a new medicine being tested as a potential treatment for these blood cancers.

Who can join the study?

Adults aged 18 or older whose cancer hasn't responded to other treatments or for whom other treatments aren't suitable, and who meet certain health criteria.

Will I get normal cancer treatment in this study?

You might receive EP0042 alone, or it could be combined with other standard cancer medicines like Venetoclax or Azacitidine, as part of the study.

What if I want to stop being in the study?

You can leave the study at any time, for any reason, without it affecting your medical care.

How to find out more

Clinical Trials Team

enquiries@ellipses.life +44 20 3743 0992 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.