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Tests treatment safety and results for Acute Myeloid Leukemia
Official title Study to Evaluate the Safety and Tolerability of EP0042
ClinicalTrials.gov ID: NCT04581512
What this study is testing
What is EP0042?
EP0042 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for acute myeloid leukemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- General
- 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...
- 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.
You likely can't join if
- Patients with any of the following will not be included in the study: Disease Under Study and Prior Anticancer Treatment
- 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...
- Ongoing toxic manifestations of previous treatments that have not reduced to at least CTCAE Grade 1. Exceptions to this are alopecia or certain Grade...
- Transplantation (allogeneic or autologous) within last 90 days, or on active immunosuppressive therapy for graft versus host disease in last 2 weeks...
See the full eligibility criteria
- General
- 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.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2 at screening
- 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
- 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...
- Patients with relapsed/refractory FLT3 WT AML.
- Previous exposure to venetoclax, hypomethylating agent and/or FLT3 inhibitors (gilteritinib, midostaurin, quizartinib, sorafenib) is allowed for relapsed/refractory AML patients.
- Mutation status of patients must be known at trial entry.
- 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
- 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
- Patients with any of the following will not be included in the study: Disease Under Study and Prior Anticancer Treatment
- 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...
- 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...
- Transplantation (allogeneic or autologous) within last 90 days, or on active immunosuppressive therapy for graft versus host disease in last 2 weeks Laboratory Parameters
- Patient with any out-of-range laboratory values defined as shown below.
- Creatinine clearance (calculated using Cockcroft-Gault formula, or measured) \< 50 mL/ min
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Perth, Western Australia, Australia
- Amsterdam, Netherlands
- Rotterdam, Netherlands
- London, UK, United Kingdom
- London, United Kingdom
- Manchester, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Perth, Western Australia, Australia; Amsterdam, Netherlands; Rotterdam, Netherlands; London, UK, United Kingdom; London, United Kingdom; Manchester, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.