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Clinical Trials in the UK / NCT04581512
Recruiting Phase 1/2

Study to Evaluate the Safety and Tolerability of EP0042

NCT04581512 · tracked via the Priya Life Science UK tracker
Sponsor
Ellipses Pharma
Phase
Phase 1/2
Started
2020-11-02
Last updated
2026-06-22

Condition(s) studied

Acute Myeloid LeukemiaChronic Myelomonocytic LeukemiaMyelodysplastic Syndromes

Investigational drug(s) / intervention(s)

EP0042VenetoclaxAzacitidine (AZA)

EP0042: EP0042 Oral 20 mg 50 mg capsules

Venetoclax: Venetoclax

Azacitidine (AZA): Azacitidine

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
General 1. Male or female patients aged ≥ 18 years of age, at the time of informed consent, with histological or cytological confirmation of AML 2. Ability to understand and provide written informed consent before any study-specific procedures, sampling, or analyses, including access to archival tumor tissue 3. Ability to swallow and retain oral medication 4. Sufficient life expectancy to allow the patient to complete at least 1 cycle (28 days) of the treatment period. 5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2 at screening 6. In the opinion of the investigator, all other relevant medical conditions must be well-managed and stable for at least 28 days prior to first administration of study drug 7. Patients with pathologically confirmed/documented AML or MDS, as defined by the 2022 European LeukaemiaNet (ELN) recommendations, or CMML, as defined by World Health Organization (WHO) criteria, who have relapsed from or are refractory to previous therapy and have failed all (or are not eligible for/intolerant to) available approved therapies for their disease. 8. Patients with relapsed/refractory FLT3 WT AML. 9. Previous exposure to venetoclax, hypomethylating agent and/or FLT3 inhibitors (gilteritinib, midostaurin, quizartinib, sorafenib) is allowed for relapsed/refractory AML patients. 10. Mutation status of patients must be known at trial entry. 11. Female patients should either be of non-child-bearing potential or must agree to use highly effective methods of contraception from Screening until 6 months following administration of the last dose of study drug 12. Male patients must use double barrier contraception from enrolment through treatment and for 6 months following administration of the last dose of study drug 5.2 Core Exclusion Criteria Patients with any of the following will not be included in the study: Disease Under Study and Prior Anticancer Treatment 1. Suspected brain and/or leptomeningeal metastases that are symptomatic or untreated or that require current therapy 2. Acute promyelocytic leukemia (FAB:M3) 3. Systemic anti-cancer therapy for the disease under study within 2 weeks of the first dose of study treatment. If the previous anti-cancer therapy has a very long half-life and may interact with EP0042, e.g. a strong CYP3A4 inhibitor, the washout period may need to be increased for safety reasons but will be no longer than 3 weeks (Concomitant hydroxyurea is acceptable and will be permitted throughout the screening period and during first 6 cycles of study treatment) 4. Ongoing toxic manifestations of previous treatments that have not reduced to at least CTCAE Grade 1. Exceptions to this are alopecia or certain Grade 2 treatment related toxicities, which in the opinion of the Investigator should not exclude the patient. 5. Transplantation (allogeneic or autologous) within last 90 days, or on active immunosuppressive therapy for graft versus host disease in last 2 weeks Laboratory Parameters 6. Patient with any out-of-range laboratory values defined as shown below. • Creatinine clearance (calculated using Cockcroft-Gault formula, or measured) \< 50 mL/ min 7. Inadequate liver function as demonstrated by * total serum bilirubin ≥ 1.5 times the upper limits of normal range (ULN) or * ALT ≥3 times the ULN or * AST ≥3 times the ULN or * AST or ALT ≥5 times the ULN in the presence of liver involvement by leukemia

Primary outcome measure(s)

Trial sites (6)

FacilityCityRegionStatus
Royal Perth Hospital Perth Western Australia Recruiting
Amsterdam UMC Amsterdam Netherlands Recruiting
Erasmus MC Rotterdam Netherlands Recruiting
The Royal Marsden London UK Recruiting
University College London Hospital London United Kingdom Recruiting
The Christie Hospital Manchester United Kingdom Recruiting

On this site

📄 Venclexta (venetoclax) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04581512 on ClinicalTrials.gov ↗ ← All trials in the UK