A Study to Assess the Efficacy and Safety of Enzalutamide in Subjects With Advanced Hepatocellular Carcinoma
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|ClinicalTrials.gov Identifier: NCT02528643|
Recruitment Status : Active, not recruiting
First Posted : August 19, 2015
Last Update Posted : August 2, 2018
The purpose of the study is to evaluate the efficacy of enzalutamide in subjects with advanced hepatocellular carcinoma (HCC) as measured by overall survival (OS).
This study will also evaluate 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 subjects with advanced HCC.
|Condition or disease||Intervention/treatment||Phase|
|Advanced Hepatocellular Carcinoma||Drug: enzalutamide Drug: placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||165 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Enzalutamide in Subjects With Advanced Hepatocellular Carcinoma|
|Actual Study Start Date :||November 9, 2015|
|Actual Primary Completion Date :||October 2, 2017|
|Estimated Study Completion Date :||May 2019|
Placebo Comparator: placebo
- Overall Survival (OS) [ Time Frame: Up to 24 months ]OS is defined as the time from the date of randomization until date of death from any cause.
- Safety profile of enzalutamide as assessed by adverse events, serious adverse events, laboratory tests, vital signs, electrocardiograms (ECG) and physical exams [ Time Frame: Up to 48 months ]Laboratory tests consist of hematology, chemistry, coagulation, viral load, pregnancy and urinalysis.
- Pharmacokinetics of enzalutamide and N-desmethyl enzalutamide in plasma: Cmin [ Time Frame: Weeks 5, 9 and 13 ]Cmin: Minimum concentration
- Progression Free Survival (PFS) [ Time Frame: Up to 48 months ]PFS is defined as the time from the date of randomization until the date of documented radiographic disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by the investigator or death from any cause on study, whichever occurs first.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02528643
Show 38 Study Locations
|Study Director:||Executive Medical Director||Astellas Pharma Global Development, Inc.|