Actively Recruiting
Study to Evaluate the Safety and Tolerability of EP0042
Led by Ellipses Pharma · Updated on 2025-10-14
70
Participants Needed
6
Research Sites
317 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Study to Evaluate the Safety and Tolerability of EP0042
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 18 years or older with confirmed AML
- Ability to provide written informed consent
- Ability to swallow and retain oral medication
- Life expectancy sufficient to complete at least one 28-day treatment cycle
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2 at screening
- Well-managed and stable medical conditions for at least 28 days before first study drug dose
- Patients with relapsed or refractory AML, MDS, or CMML who failed or are not eligible for approved therapies
- Patients with relapsed/refractory FLT3 WT AML
- Previous exposure to venetoclax, hypomethylating agents, or FLT3 inhibitors allowed
- Known mutation status at trial entry
- Female patients must be non-child-bearing or agree to use effective contraception during and 6 months after treatment
- Male patients must use double barrier contraception during and 6 months after treatment
You will not qualify if you...
- Symptomatic or untreated brain or leptomeningeal metastases requiring therapy
- Acute promyelocytic leukemia (FAB:M3)
- Anti-cancer therapy for the disease within 2 weeks before first study drug dose (up to 3 weeks if interaction risk)
- Ongoing toxic effects of previous treatments not reduced to at least CTCAE Grade 1 (except alopecia or certain Grade 2 toxicities as per investigator)
- Transplantation within last 90 days or active immunosuppressive therapy for graft versus host disease within 2 weeks
- Creatinine clearance less than 50 mL/min
- Liver function abnormalities: total bilirubin ≥1.5 times, ALT ≥3 times, AST ≥3 times upper limit of normal, or AST/ALT ≥5 times if leukemia involves liver
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Royal Perth Hospital
Perth, Western Australia, Australia, 6000
Actively Recruiting
2
Amsterdam UMC
Amsterdam, Amsterdam, Netherlands, 1081HV Amsterdam
Actively Recruiting
3
Erasmus MC
Rotterdam, Rotterdam, Netherlands, 3000 CA Rotterdam
Actively Recruiting
4
University College London Hospital
London, London, United Kingdom, W1T 7HA
Actively Recruiting
5
The Royal Marsden
London, UK, United Kingdom
Actively Recruiting
6
The Christie Hospital
Manchester, United Kingdom, M204BX
Actively Recruiting
Research Team
C
Clinical Trials Team
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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