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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
EP0042
DrugEP0042 Oral 20 mg 50 mg capsules
Venetoclax
DrugVenetoclax
Azacitidine (AZA)
DrugAzacitidine
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Module 1 EP0042Experimental treatment 1 intervention
Group B: Module 2 EP0042Experimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Incidence of dose-limiting toxicities (DLTs) from the first dose through the end of the DLT observation period.
Incidence of dose-limiting toxicities (DLT)
Time frame
First cycle of treatment (28 Days)Sponsors and contacts
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Source ClinicalTrials.gov