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

NCT02528643 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2024-12-06

Study results available
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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.

Conditions

Interventions

DRUG

Enzalutamide

Oral capsule

DRUG

Placebo

Oral capsule

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Astellas Pharma Global Development, Inc.

    lead INDUSTRY

Principal Investigators

  • Executive Medical Director · Astellas Pharma Global Development, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-09
Primary Completion
2017-10-02
Completion
2021-02-09
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Hong Kong
  • Italy
  • Puerto Rico
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02528643 on ClinicalTrials.gov