Amsterdam UMC | IBD Center - Clinical Trial Unit
Status and phase
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About
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).
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Inclusion and exclusion criteria
General
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
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.
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
Primary purpose
Allocation
Interventional model
Masking
70 participants in 1 patient group
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Central trial contact
Ayan Yusuf; Tobi Arkenau
Data sourced from clinicaltrials.gov
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