Full TitleSingle-Arm, Open-Label, Phase II Study of LY3023414 for the Treatment of Recurrent or Persistent Endometrial Cancer
PurposeThe purpose of this study is to evaluate the safety and effectiveness of the investigational drug LY3023414 in women with endometrial cancer that has come back despite prior therapy or has continued to grow despite treatment. LY3023414 works by blocking the activity of two proteins known to fuel cancer growth: PI3 kinase (PI3K) and mTOR, which work abnormally in most endometrial cancers. LY3023414 is a capsule that is taken orally (by mouth).
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have endometrial cancer that has come back despite prior therapy or has continued to grow despite treatment.
- Patients’ tumors must contain alterations in the PI3K-AKT-mTOR pathway.
- Patients whose tumors also contain RAS/RAP or MAP kinase alterations may not participate, because these changes can cause a lack of response to drugs like LY3023414.
- Patients must have had at least one but no more than two prior regimens of chemotherapy.
- At least 2 weeks must pass between the completion of prior therapy and entry into the study.
- Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
- This study is for women age 18 and older.