A Phase I/II Study of Enzalutamide with and without Sorafenib in Patients with Advanced Liver Cancer

Full Title

A Multicenter Phase 1/2 Study of Enzalutamide With and Without Sorafenib in Advanced Hepatocellular Carcinoma Patients

Purpose

Patients with hepatocellular carcinoma (liver cancer) who cannot be treated with surgery, liver transplantation, ablation, or embolization are typically treated with the drug sorafenib. However, in many cases the tumor eventually continues to grow. In this study, researchers are evaluating the best dose of the drug enzalutamide in patients whose liver cancer continues to grow despite sorafenib. They are also evaluating the combination of enzalutamide and sorafenib in patients with advanced liver cancer who have not yet received sorafenib, to find the optimal dose of sorafenib as part of this drug duo.

There will be two groups in this study:

  1. Patients who previously received sorafenib will only take enzalutamide.
  2. Patients who have not yet received sorafenib will take both sorafenib and enzalutamide.

Enzalutamide blocks the hormone testosterone from binding to a protein on cells called the androgen receptor. It is approved for the treatment of men with advanced prostate cancer. Blocking the androgen receptor may also slow or stop tumor growth in patients with liver cancers that contain the androgen receptor. Sorafenib works by targeting several proteins involved in liver cancer growth. Both enzalutamide and sorafenib 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 advanced inoperable or metastatic liver cancer that cannot be treated with liver transplantation or regional therapies.
  • 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 about this study and to inquire about eligibility, please contact Dr. James J. Harding at 646-888-4314.

Protocol

15-279

Phase

I

Investigator

Co-Investigators

Locations