A Phase IB Study of BYL719 plus Everolimus in Patients with Advanced Cancers

Full Title

A Phase Ib Dose-finding Study of BYL719 Plus Everolimus and BYL719 Plus Everolimus Plus Exemestane in Patients with Advanced Solid Tumors, with Dose-expansion Cohorts in Renal Cell Cancer (RCC), Pancreatic Neuroendocrine Tumors (pNETs), and Advanced Breast Cancer (BC) Patients


The purpose of this study is to find the highest dosage of a two-drug combination — everolimus and BYL719 — that can be given safely in patients with advanced cancers that are large or have spread and cannot be cured with standard therapies.

Everolimus is approved for treating several types of cancer. It works by blocking mTOR, a protein that some cancer cells need to grow. BYL719 is an investigational drug that inhibits PI3 kinase, an enzyme which fuels the growth of several types of cancer.

Laboratory studies suggest that giving everolimus and BYL719 together may be more effective than giving either drug alone. Both drugs are 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 an advanced solid tumor that is large or has spread and cannot be cured with standard therapy.
  • At least 4 weeks must pass between completion of prior therapy and entry into the study, and patients must recover from any serious side effects.
  • Patients may not have had previous treatment with PI3 kinase or mTOR inhibitors.
  • Patients must be able to be 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 about this study and to inquire about eligibility, please contact Dr. Anna Varghese at 646-888-4308.