At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 165 enrolled
Drug / intervention
Enzalutamide +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Enzalutamide in Subjects With Advanced Hepatocellular Carcinoma
In Brief
A Phase 2 clinical trial evaluating Enzalutamide and Placebo for Advanced Hepatocellular Carcinoma. Completed, enrolled 165 participants across 38 sites in 9 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Hepatocellular Carcinoma
CountriesCanada, Hong Kong, Italy, Puerto Rico, South Korea, Spain, Taiwan, United Kingdom, United States
CollaboratorsPfizer
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 2015
Enrollment StartNov 2015
Primary CompletionOct 2017
Study CompletionFeb 2021
TodayJul 2026
First PostedAug 19, 2015
Enrollment StartNov 9, 2015
Primary CompletionOct 2, 2017
Study CompletionFeb 9, 2021
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 10.9 years ago
Interventions
Enzalutamidedrug
Oral capsule
Placebodrug
Oral capsule