At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- EP0042 (drug), Venetoclax (drug), Azacitidine (AZA) (drug)
- How long the study runs
- Study runs about 85 months (dates as stated)
- About the drug or intervention
- EP0042 — drug: EP0042 Oral 20 mg 50 mg capsules · Venetoclax — drug: Venetoclax · Azacitidine (AZA) — drug: Azacitidine
- Patient visit burden
- Not specified by the sponsor
In plain English
This study is testing a new medicine called EP0042 to see how safe it is and how well people cope with it. It is for adults with acute myeloid leukaemia (AML), chronic myelomonocytic leukaemia (CMML), or myelodysplastic syndromes (MDS) whose disease has come back or has not responded to previous treatment. The study is run by Ellipses Pharma.
Who can take part
- Adults aged 18 or over with confirmed AML, MDS or CMML
- Disease has come back (relapsed) or has not responded (refractory) to previous treatment, and other approved treatments are not an option
- Able to give written informed consent and to swallow and keep down tablets
- Well enough to complete at least one 28-day treatment cycle, with enough life expectancy to do so
- Performance status (how well you can carry out daily activities) of 0 to 2 at screening
- Other medical conditions must be well managed and stable for at least 28 days before starting the study drug
- Known mutation status at the start of the trial, including AML without a FLT3 gene change (FLT3 wild type)
- Previous treatment with venetoclax, hypomethylating agents or FLT3 inhibitors is allowed
- People able to become pregnant, or male participants, must agree to use highly effective contraception during treatment and for 6 months after the last dose
Who may not be able to
- Suspected cancer spread to the brain or the lining around it that is causing symptoms, is untreated, or needs treatment now
- A specific type of AML called acute promyelocytic leukaemia
- Anti-cancer treatment for this disease within 2 weeks of the first study dose (up to 3 weeks for some longer-lasting medicines). Hydroxyurea is allowed during screening and the first 6 treatment cycles
- Ongoing side effects from previous treatment that have not improved enough, except hair loss or some milder side effects a doctor judges acceptable
- A stem cell or bone marrow transplant (from yourself or a donor) in the last 90 days, or taking immunosuppressive drugs for graft versus host disease in the last 2 weeks
- Kidney problems: creatinine clearance (a measure of kidney function) below 50 mL/min
- Liver problems: bilirubin 1.5 times or more the upper limit of normal, or liver enzymes (ALT or AST) above set limits, or higher limits if leukaemia affects the liver
What taking part involves
- • Taking EP0042 as a tablet by mouth
- • Treatment is given in cycles, each lasting 28 days
Time commitment: Not stated — ask the trial team. Each treatment cycle lasts 28 days, and participants need to be able to complete at least one cycle.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 70
- Started
- 2020-11-02
- Last checked
- 2026-06
Plain English Summary
What is this study?
- • Testing a new treatment for acute myeloid leukemia
- • Phase1/Phase2 - 70 participants
- • A research study looking at a new treatment for patients with advanced cancer, to investigate different doses of the experimental study drug, EP0042, in order to determine a dose, which is safe, well-tolerated and likely to be effective in treating AML (acute myeloid leukaemia)
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with acute myeloid leukemia
Where?
- • London - The Royal Marsden
- • London - University College London Hospital
- • Manchester - The Christie Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
A research study looking at a new treatment for patients with advanced cancer, to investigate different doses of the experimental study drug, EP0042, in order to determine a dose, which is safe, well-tolerated and likely to be effective in treating AML (acute myeloid leukaemia).
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ and have failed all (
- ✓ current therapy
What the study is looking for
- ✓General
- ✓Male or female patients aged ≥ 18 years of age, at the time of agreement to take part, with histological or cytological...
- ✓Ability to understand and provide written agreement to take part before any study-specific procedures, sampling, or...
- ✓Ability to swallow and retain oral medication
- ✓Sufficient life expectancy to allow the patient to complete at least 1 cycle (28 days) of the treatment period.
See the full criteria
Where Is This Study? (3 UK sites)
The Royal Marsden
London, United Kingdom
University College London Hospital
London W1T 7HA, United Kingdom
Rajinder Sidhu - Associate Director, Research Governance and Operations
uclh.jro-communications@nhs.net020 3447 9825The Christie Hospital
Manchester M204BX, United Kingdom
How to Get in Touch
Clinical Trials Team
Sponsor contactCONTACT
