Study to Evaluate the Safety and Tolerability of EP0042
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorEllipses Pharma
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 groupsSponsors and collaborators
Source ClinicalTrials.gov