A Phase I Study of AEB071 and BYL719 in Patients with Metastatic Uveal Melanoma

Full Title

Phase IB Trial of AEB071, a PKC Inhibitor, in Combination with BYL719, a PI3Ka Inhibitor, in Patients with Metastatic Uveal Melanoma

Purpose

The purpose of this study is to find the highest doses of two investigational drugs, AEB071 and BYL719, that can be given safely in patients with uveal melanoma that has spread outside the eye. AEB071 works by blocking an enzyme involved in uveal melanoma growth called protein kinase C, while BYL719 inhibits another cancer-fueling enzyme called PI3 kinase. Both drugs are taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have uveal melanoma that has spread beyond the eye.
  • At least 4 weeks must pass between completion of prior therapies and entry into the study.
  • Patients with type 2 diabetes mellitus must have excellent control of their blood sugar.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Alexander Shoushtari at 646-888-4161.

Protocol

15-056

Phase

I

Co-Investigators

Locations