drugset
drugset / Trial / NCT02642913

Study of Enzalutamide With and Without Sorafenib in Advanced Hepatocellular Carcinoma Patients

NCT02642913 ↗

Phase 1 Completed 28 enrolled Memorial Sloan Kettering Cancer Center Astellas Pharma US, Inc. · collabMayo Clinic · collabNational Comprehensive Cancer Network · collabRoswell Park Cancer Institute · collabUniversity of California, San Francisco · collabUniversity of Southern California · collabWashington University School of Medicine · collab
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2015-12
Primary completion
2021-03-01
Completion
2021-03-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Enzalutamide Other / unclassified — Oral
Subject Sorafenib Small molecule — Oral

Indications

hepatocellular carcinoma