A Phase Ib Study of Oral BGJ398 and BYL719 in Patients with Certain Advanced Solid Tumors

Protocol
13-246
Full Title
A Phase Ib, Open-Label Study of Oral BGJ398 in Combination with Oral BYL719 in Adult Patients with Select Advanced Solid Tumors
Phase
I
Purpose

The purpose of this study is to find the highest dose of two investigational anticancer drugs when given together in patients with advanced solid tumors. The drugs are BGJ398 and BYL719.

BGJ398 and BYL719 are inhibitors of PI3 kinase, an enzyme which fuels the growth of several types of cancer. 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 an advanced solid tumor that has continued to grow despite standard therapy or for which no standard therapy exists.
  • Patients tumors must contain a mutation in the PI3KCA gene, which is responsible for the abnormal PI3 kinase.
  • Patients should recover from the serious side effects of previous treatment before they enter the study.
  • Patients must be able to be walk and do routine activities for more than half of their normal waking hours.
  • This study is open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Matthew G. Fury at 646-888-4233.

Disease(s)
Breast Cancer
Solid Tumors
Locations
Related Diseases