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
Results First Posted : November 20, 2018
Last Update Posted : November 20, 2018
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.
|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|
Participants received enzalutamide 160 mg once daily until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants received 160 mg enzalutamide oral capsules (4 x 40 mg capsules) one daily.
Placebo Comparator: Placebo
Participants received placebo once daily until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
Participants received placebo to match enzalutamide oral capsules once daily.
- Overall Survival (OS) [ Time Frame: From date of randomization up to data cut-off date 02 Oct 2017 (approximately 22 months); median follow-up time was 14.65 months for enzalutamide and 13.83 for placebo. ]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.
- Number of Participants With Adverse Events (AEs) [ Time Frame: From first dose of study drug up to 30 days after last dose of study drug (up to data cut-off 02 Oct 2017, approximately 660 days); median (minimum, maximum) treatment duration was 71.0 (6, 574) days for enzalutamide and 64.0 (13, 385) for placebo. ]Safety was assessed by AEs, which included abnormalities identified during a medical test (e.g. laboratory tests, vital signs, electrocardiogram, etc.) if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A treatment-emergent AE (TEAE) was defined as an AE observed after starting administration of the study drug up to 30 days after last dose of study drug or initiation of new treatment, whichever comes first. AEs were considered as serious if resulted in in death, was life-threatening resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, resulted in congenital anomaly or birth defect, required inpatient hospitalization or led to prolongation of hospitalization and other medically important events.
- Plasma Trough Concentrations of Enzalutamide [ Time Frame: Predose at weeks 5, 9 and 13 ]Blood samples were collected for analysis.
- Plasma Trough Concentrations N-desmethyl Enzalutamide (M1 Metabolite) [ Time Frame: Predose at weeks 5, 9 and 13 ]Blood samples were collected for analysis.
- Plasma Trough Concentrations of MDPC0001 (M2 Metabolite) [ Time Frame: Predose at weeks 5, 9 and 13 ]Blood samples were collected for analysis.
- Progression Free Survival (PFS) [ Time Frame: From date of randomization up to data cut-off date 02 Oct 2017 (approximately 22 months); median follow-up time was 14.65 months for enzalutamide and 13.83 for placebo. ]PFS was 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 determined by the investigator or death from any cause on study, whichever occurred first. The earliest of the censoring times was used: Participants with (1) no evaluable postbaseline imaging assessments or did not die were censored at the randomization date; (2) no radiographical progression or did not die before analysis cutoff date were censored at the last radiological assessment date before analysis cutoff date; (3) with no radiographical progression or did not die before new HCC treatment was censored at the last radiological assessment date before start of new HCC treatment. Based on Kaplan-Meier.
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
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|Study Director:||Executive Medical Director||Astellas Pharma Global Development, Inc.|