Acute Myeloid Leukemia Clinical Trial
Official title:
Prexasertib in Combination With Mitoxantrone, Etoposide and Cytarabine (MEC) in Relapsed/Refractory Acute Myeloid Leukemia (AML) and High Risk Myelodysplastic Syndrome (MDS) - a Phase I Trial
This research study is studying a targeted therapy combined with chemotherapy as a possible
treatment for acute myeloid leukemia (AML) or high risk myelodysplastic syndrome (MDS).
The drugs involved in this study are:
- Prexasertib (LY2606368)
- Mitoxantrone
- Etoposide
- Cytarabine
This research study is a Phase I clinical trial, which tests the safety of an investigational
drug or combination of drugs and also tries to define the appropriate dose of the
investigational intervention to use for further studies. "Investigational" means that the
drug is being studied.
The FDA (the U.S. Food and Drug Administration) has not approved prexasertib as a treatment
for any disease. Prexasertib is a checkpoint kinase 1 (CHK1) inhibitor that is being
developed as a treatment for patients with advanced cancer. CHK1 inhibitors work by
preventing cancer cells from being able to repair damaged DNA (one of the building blocks of
a cell) which then leads to cell death.
The drugs mitoxantrone, etoposide, and cytarabine (MEC) have all been approved by the FDA.
MEC is a standard chemotherapy treatment option, commonly used for AML that has not responded
to other standard treatment or returned following standard treatment.
In this research study, the investigators are combining prexasertib with MEC therapy to test
if it is a safe treatment for AML or MDS that has returned or not responded to standard
treatment.
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