A Pilot Study of AZD5363 in Patients with Advanced Solid Tumors with AKT Mutations

Full Title

A Pilot Study of AZD5363 for Patients with Advanced Solid Tumors Harboring Mutations in AKT1, AKT2, or AKT3

Purpose

The purpose of this study is to determine if the investigational drug AZD5363 helps treat patients with advanced solid tumors containing mutations in a gene that produces the AKT protein. Blocking the action of AKT with a drug like AZD5363 may stop the cancer from growing. AZD5363 is taken orally (by mouth).

Patients who have estrogen receptor-positive breast cancer with an AKT mutation will also receive a standard breast cancer drug called fulvestrant, which is given as an injection. Patients who have prostate cancer with an AKT mutation will also receive the prostate cancer drug enzalutamide, which that is taken orally.

Eligibility

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

  • Patients must have a recurrent or metastatic solid tumor that contains a mutation in the AKT gene and cannot be cured with standard therapies.
  • Patients with breast cancer must be postmenopausal and have experienced cancer progression despite receiving fulvestrant.
  • Patients with prostate cancer must have experienced cancer progression despite receiving enzalutamide.
  • Patients must recover from the serious side effects of prior therapies before entering 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 patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Lillian Smyth or Dr. David Hyman at 646-888-4226.

Protocol

17-322

Phase

Pilot

Investigator

Co-Investigators