A Phase I/II, Open-label, Multicentre 2-part Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of AZD2811 Nanoparticle as Monotherapy or in Combination in Treatment-naïve or Relapsed/refractory Acute Myeloid Leukaemia/Myelodysplastic Syndrome Patients Not Eligible for Intensive Induction Therapy

Protocol No
AZ-D6130C00003-HEMREF41
Principal Investigator
Ehab Atallah
Phase
I/II
Summary
AZD2811 will be referred to as study drug throughout this consent. The study drug is an Aurora B kinase inhibitor. It interferes with or inhibits the process of cell division. In this study the study drug has been incorporated in a different size carrier (called a nanoparticle, which is a particle in a liquid that carries the active drug) which may allow for a shorter time to infuse the drug. Nanoparticle carriers when combined with some cancer treatment drugs may stay in the body longer with possibly fewer side effects. This study is being done to find out the following about the study drug; What is the optimal dose and schedule of the study drug in subjects with relapsed acute myeloid leukemia (AML), high-risk myelodysplastic syndrome (MDS) or previously untreated subjects not eligible for intensive induction therapy or allogeneic transplantation solid tumors? What side effects occur when the study drug is given? How serious are these side effects and how long do they last? How long after dosing does the study drug remain in your body? (This type of research is called pharmacokinetics [PKs]). Is the study drug effective in improving overall response rate and survival? How does the study drug act on and in the body? We find this out by assessing biomarkers in blood and bone marrow samples. Biomarker samples can show what effects the study drug has on some cell functions in your body and may predict how people may respond to the study drug.
Description
AZD2811 Nanoparticle in Patients with Relapsed AML/High-Risk MDS
Participating Institutions
Froedtert Hospital
Status
OPEN TO ACCRUAL
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