This research study is a Phase I clinical trial. Phase I trials test the safety of an
investigational drug or combination of drugs. Phase I studies also try to define the
appropriate dose of the investigational drug to use for further studies. "Investigational"
means that the combination of drugs is still being studied and that research doctors are
trying to find out more about it. As part of this research study, you will take alisertib in
combination with idarubicin and cytarabine. Alisertib has not been approved by the FDA for
your cancer. However, cytarabine and idarubicin have both been approved by the FDA for
treatment of AML. It also means that the FDA has not approved giving alisertib with
idarubicin and cytarabine for use in patients, including patients with your type of cancer.
Idarubicin and cytarabine are chemotherapy agents that are commonly used to treat individuals
diagnosed with AML. Alisertib has been used in laboratory studies and those studies suggest
that alisertib may slow down the spread of your cancer. It does this by blocking certain
substances needed by the cancer cells to spread. In this study, researchers would like to
combine alisertib with standard chemotherapy (cytarabine and idarubicin) in order to see if
it can be given safely with chemotherapy in individuals with AML.
The primary purpose of this research study is to determine the highest dose that alisertib
can be given with idarubicin and cytarabine without severe or unmanageable side effects. The
dose identified in this study will be used in future research studies.