Spots Global Cancer Trial Database for An Asian Study to Evaluate Efficacy and Safety of Oral Enzalutamide in Progressive Metastatic Prostate Cancer Participants
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Trial Identification
Brief Title: An Asian Study to Evaluate Efficacy and Safety of Oral Enzalutamide in Progressive Metastatic Prostate Cancer Participants
Official Title: Asian Multinational Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Oral Enzalutamide in Chemotherapy Naïve Subjects With Progressive Metastatic Prostate Cancer Who Have Failed Androgen Deprivation Therapy
Study ID: NCT02294461
Conditions
Study Description
Brief Summary: Purpose of the study was to assess the effect of enzalutamide on time to Prostate Specific Antigen (PSA) progression as compared to placebo in chemotherapy naïve participants with progressive metastatic prostate cancer who have failed androgen deprivation therapy.
Detailed Description: The study was a multinational Phase 3, randomized, double-blind, placebo-controlled efficacy and safety study of oral enzalutamide (formerly MDV3100) in asymptomatic or mildly symptomatic participants with progressive metastatic prostate cancer who have disease progression despite androgen deprivation therapy. In order to join the study, participants could not have been previously treated with cytotoxic chemotherapy. Approximately 30 Chinese participants were allocated to the pharmacokinetic (PK) cohort. Participants in the PK cohort were required to be hospitalized from Day 1 before the randomization date to at least the completion of all the assessments planned on Day 3. All participants in the PK cohort underwent blood sampling for the PK analysis. Data reported in the results section was based on data cutoff dates of 20 Sept 2015 for efficacy and safety data and 20 Jan 2016 for PK outcome measures. The study completed double-blind period and is now in the open-label period.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
CN00103, Beijing, , China
CN00104, Beijing, , China
CN00106, Beijing, , China
CN00111, Beijing, , China
CN00112, Beijing, , China
CN00114, Beijing, , China
CN00115, Beijing, , China
CN00127, Beijing, , China
CN00121, Changsha, , China
CN00107, Hangzhou, , China
CN00110, Nanjing, , China
CN00117, Nanjing, , China
CN00102, Shanghai, , China
CN00105, Shanghai, , China
CN00108, Shanghai, , China
CN00113, Shanghai, , China
CN00126, Shanghai, , China
CN00119, Soochow, , China
CN00125, Tianjin, , China
CN00118, Wenzhou, , China
CN00109, Wu Han, , China
CN00124, Xi'an, , China
HK00402, Hong Kong, , Hong Kong
KR00214, Anyang, , Korea, Republic of
KR00205, Busan, , Korea, Republic of
KR00207, Busan, , Korea, Republic of
KR00212, Cheongju, , Korea, Republic of
KR00203, Daegu, , Korea, Republic of
KR00213, Daejeon, , Korea, Republic of
KR00201, Incheon, , Korea, Republic of
KR00202, Seongnam-si, , Korea, Republic of
KR00204, Seoul, , Korea, Republic of
KR00206, Seoul, , Korea, Republic of
KR00208, Seoul, , Korea, Republic of
KR00209, Seoul, , Korea, Republic of
KR00210, Seoul, , Korea, Republic of
KR00211, Seoul, , Korea, Republic of
KR00215, Seoul, , Korea, Republic of
TW00309, Kaohsiung, , Taiwan
TW00302, Taichung, , Taiwan
TW00303, Taichung, , Taiwan
TW00307, Tainan, , Taiwan
TW00308, Tainan, , Taiwan
TW00301, Taipei, , Taiwan
TW00304, Taipei, , Taiwan
TW00306, Taipei, , Taiwan
TW00305, Taoyuan County, , Taiwan
Contact Details
Name: Central Contact
Affiliation: Astellas Pharma Inc
Role: STUDY_DIRECTOR
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