A Phase II Study of BYL719 plus AMG 479 (Ganitumab) in Patients with Advanced Ovarian Cancer or Hormone Receptor-Positive Breast Cancer

Protocol
13-251
Full Title
A Phase Ib/II Open-Label, Multi-Center Study of the Combination of BYL719 Plus AMG 479 (Ganitumab) in Adult Patients with Selected Advanced Solid Tumors
Phase
I/II
Purpose

The purpose of this study is to assess the safety and effectiveness of two investigational drugs when given together in patients with advanced ovarian cancer or hormone receptor-positive breast cancer. The drugs are BYL719 and AMG 479 (ganitumab).

BYL719 is an inhibitor of PI3 kinase, an enzyme which fuels the growth of several types of cancer. It is taken orally (by mouth). AMG 479 is designed to bind to a protein on the surface of cancer cells called insulin-like growth factor receptor 1 (IGF-1R), inhibiting its ability to interact with other proteins and stopping cancer cell growth in laboratory studies. AMG 479 is given intravenously (by vein).

It is believed that giving BYL719 and AMG 479 together may be more effective than giving these two drugs alone.

Eligibility

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

  • Patients must have advanced ovarian cancer or hormone receptor-positive breast cancer that contains mutated or excessive PI3 kinase.
  • Patients’ cancers must have continued to grow despite prior standard therapy.
  • Patients may not have previously received drugs that target PI3 kinase or IGF-1R.
  • Patients must have recovered from the serious side effects of prior therapies.
  • 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. Shanu Modi at 646-888-4564 (for breast cancer patients) or Dr. Jason Konner at 646-888-4219 (for ovarian cancer patients).

Disease(s)
Breast Cancer
Ovarian Cancer
Locations