Health Trials

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).

Eligibility criteria

Qualifiers

Male or female patients aged ≥ 18 years of age, at the time of informed consent, with histological or cytological confirmation of AML

Ability to understand and provide written informed consent before any study-specific procedures, sampling, or analyses, including access to archival tumor tissue

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.

Disqualifiers

Suspected brain and/or leptomeningeal metastases that are symptomatic or untreated or that require current therapy

Acute promyelocytic leukemia (FAB:M3)

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)

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.

Trial design

Treatments tested in this trial

  • EP0042
  • Venetoclax
  • Azacitidine (AZA)

Treatment groups

70 Participants
are divided into 2 treatment groups

Locations

6
Australia
Royal Perth Hospital6000, PerthWestern Australia, Australia
Netherlands
Amsterdam UMC1081HV Amsterdam, Amsterdam Netherlands
Erasmus MC3000 CA Rotterdam, Rotterdam Netherlands
United Kingdom
The Royal Marsden LondonUK, United Kingdom

Sponsors and collaborators

Ellipses Pharma

Lead sponsor

Source ClinicalTrials.gov