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

Hepatocellular Carcinoma Clinical Trial

Official title: A Multicenter Phase I/II Study of Enzalutamide With and Without Sorafenib in Advanced Hepatocellular Carcinoma Patients

Status Completed

Clinical Trial 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.

Clinical Trial Description

This is a multicenter, open label, phase I/II study of enzalutamide with or without sorafenib to define the safety, MTD, and pharmacokinetic parameters of each regimen in advanced HCC patients.

The study will have 4 parts as indicated in the Study Schema, an enzalutamide dose escalation (Part 1A), a sorafenib and enzalutamide dose escalation (Part 1B), and dose expansion cohorts for the Part 1A and Part 1B MTDs (Part 2). Dose escalation will occur using a standard 3 + 3 design and is described in Section 4.2.1. For Part 2, the enzalutamide expansion cohort (Part 2A), will enroll 10 patients and is exploratory in nature; however, it will allow for acquisition of additional PK sampling at the MTD, for determination of safety and efficacy. The MTD sorafenib and enzalutamide combination expansion (Part 2B) will be designed using a Simon minimax design to formally evaluate the 4-month PFS. ;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

• NCT number: NCT02642913
• Study type: Interventional
• Source: Memorial Sloan Kettering Cancer Center
• Status: Completed
• Phase: Phase 1
• Start date: December 2015
• Completion date: March 1, 2021