A Study to Assess the Efficacy and Safety of Enzalutamide in Subjects With Advanced Hepatocellular Carcinoma

Phase 2 Completed 165 enrolled Astellas Pharma Global Development, Inc. Pfizer · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of the study was to evaluate the efficacy of enzalutamide in participants with advanced hepatocellular carcinoma (HCC) as measured by overall survival (OS). This study also evaluated the safety of enzalutamide; pharmacokinetics of enzalutamide and the active metabolite N-desmethyl and Progression Free Survival (PFS) of enzalutamide as compared to placebo in participants with advanced HCC.

Timeline

Start: 2015-11-09
Primary completion: 2017-10-02
Completion: 2021-02-09

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo vs Enzalutamide; p = 0.248; Hazard Ratio (HR) 1.146 (95% CI 0.774 to 1.696) NCT02528643 ↗

paper CONCLUSIONS: The results of this study indicate that enzalutamide does not provide a benefit in patients with advanced HCC. PMID 34351608 ↗

Publications

Ryoo BY, Palmer DH, Park SR, Rimassa L, Debashis Sarker, Daniele B, Steinberg J, Lopez B, Lim HY. Efficacy and Safety Results from a Phase 2, Randomized, Double-Blind Study of Enzalutamide Versus Placebo in Advanced Hepatocellular Carcinoma. Clin Drug Investig. 2021 Sep;41(9):795-808. doi: 10.1007/s40261-021-01063-0. Epub 2021 Aug 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Enzalutamide	Other / unclassified	160 mg	Oral