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NCT02528643 · ClinicalTrials.gov registry record · Phase 2
A Study to Assess the Efficacy and Safety of Enzalutamide in Subjects With Advanced Hepatocellular Carcinoma
A Phase 2 study, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 165
- Enrollment target
NCT02528643: Completed Phase 2 study, sponsored by Astellas Pharma Global Development.
NCT02528643 is a Phase 2 study that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 165 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (24% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02528643, a Phase 2 study, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 165 participants
- Enrollment target
Study 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.
Primary Outcome
OS was defined as the time from the date of randomization until the documented date of death from any cause. Participants who were still alive at the time of the data cut-off date was censored on the last date known to be alive or at the data cutoff date, whichever occurs first. Results based on Kaplan-Meier estimates.
Interventions
- DRUG Placebo
- DRUG Enzalutamide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 165 participants |
| Start Date | 2015-11-09 |
| Est. Completion | 2021-02-09 |
| Phase | Phase 2 |
What the finished NCT02528643 record still lists
NCT02528643 is an interventional study that assigns participants to a tested intervention. The registered 165 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (24% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02528643 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02528643 about?
NCT02528643 is a clinical study titled "A Study to Assess the Efficacy and Safety of Enzalutamide in Subjects With Advanced Hepatocellular Carcinoma". 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 P...
What is the current status of trial NCT02528643?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 165 participants. The study started on 2015-11-09. Estimated completion is 2021-02-09.
What interventions are being tested in trial NCT02528643?
The interventions under investigation include: Placebo (DRUG), Enzalutamide (DRUG).
Who is sponsoring clinical trial NCT02528643?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02528643's enrollment target sits among peer trials
165 410th of 2000 higher than 1,588 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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