Study of Enzalutamide With and Without Sorafenib in Advanced Hepatocellular Carcinoma Patients
Status:
Completed
Trial end date:
2021-03-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to test the safety of enzalutamide with or without sorafenib at
different doses. Enzalutamide is approved by the Food and Drug Administration (FDA) for the
treatment of advanced prostate cancer. Enzalutamide blocks a protein called the androgen
receptor. Experiments on liver cancer cells and animal models show that blocking the androgen
receptor causes liver cancer to stop growing. Enzalutamide has not been approved to treat
liver cancer. The investigators want to see if enzalutamide is safe for patients with liver
cancer who have had their tumors grow on sorafenib. The investigators also want to see how
safe and effective sorafenib and enzalutamide are for liver cancer patients that have never
been treated with sorafenib. This is the first time enzalutamide and sorafenib are being used
together. This treatment may not help treat the participant's cancer.
Phase:
Phase 1
Details
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborators:
Astellas Pharma US, Inc. Mayo Clinic National Comprehensive Cancer Network Ohio State University Roswell Park Cancer Institute University of California, San Francisco University of Southern California Washington University School of Medicine