Trials / Completed
CompletedNCT02528643
A Study to Assess the Efficacy and Safety of Enzalutamide in Subjects With Advanced Hepatocellular Carcinoma
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Enzalutamide in Subjects With Advanced Hepatocellular Carcinoma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 165 (actual)
- Sponsor
- Astellas Pharma Global Development, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | Enzalutamide | Oral capsule |
| DRUG | Placebo | Oral capsule |
Timeline
- Start date
- 2015-11-09
- Primary completion
- 2017-10-02
- Completion
- 2021-02-09
- First posted
- 2015-08-19
- Last updated
- 2024-12-06
- Results posted
- 2018-11-20
Locations
38 sites across 9 countries: United States, Canada, Hong Kong, Italy, Puerto Rico, South Korea, Spain, Taiwan, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02528643. Inclusion in this directory is not an endorsement.