An Asian Study to Evaluate Efficacy and Safety of Oral Enzalutamide in Progressive Metastatic Prostate Cancer Participants

• Register: ClinicalTrials.gov
• Last refreshed on: 29 April 2024
• Main ID: NCT02294461
• Date of registration: 13/11/2014
• Prospective Registration: No
• Primary sponsor: Astellas Pharma Inc
• Public title: An Asian Study to Evaluate Efficacy and Safety of Oral Enzalutamide in Progressive Metastatic Prostate Cancer Participants
• Scientific 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
• Date of first enrolment: April 23, 2014
• Target sample size: 395
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT02294461
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

China, Hong Kong, Korea, Republic of, Taiwan

Contacts

• Name: Central Contact
• Affiliation: Astellas Pharma Inc

Key inclusion & exclusion criteria

Inclusion Criteria:

- Histologically confirmed adenocarcinoma of the prostate without neuroendocrine
differentiation or small cell features

- Ongoing androgen deprivation therapy with a GnRH analogue or bilateral orchiectomy

- Progressive disease despite androgen deprivation therapy as defined by rising PSA
levels or progressive soft tissue or bone disease

- No prior treatment with cytotoxic chemotherapy

- Asymptomatic or mildly symptomatic from prostate cancer

Exclusion Criteria:

- Severe concurrent disease, infection, or co-morbidity that, in the judgment of the
Investigator, would make the patient inappropriate for enrollment

- Known or suspected brain metastasis or active leptomeningeal disease

- History of another malignancy within the previous 5 years other than curatively
treated non-melanomatous skin cancer

- History of seizure including febrile seizure or any condition that may predispose to
seizure (e.g., prior stroke, brain arteriovenous malformation, head trauma with loss
of consciousness requiring hospitalization).



Age minimum: 18 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Progressive Metastatic Prostate Cancer

Intervention(s)

Drug: Placebo

Drug: Enzalutamide

Primary Outcome(s)

Time to Prostate-specific Antigen (PSA) Progression [Time Frame: From randomization up to data cut off date of 20 Sept 2015; median follow-up time is 7.33 months for enzalutamide and 3.02 months for placebo]

Secondary Outcome(s)

Number of Participants With Adverse Events (AE) [Time Frame: From first dose of study drug up to data cut off date of 04 Nov. 2020(up to 18.6 months for 'Placebo'; up to 4 weeks after last dose of enzalutamide-up to 84.7 months for 'Enzalutamide' and up to 54.8 months for 'Placebo followed by Enzalutamide')]

AUC From the Time of Dosing to 24 h After Dosing (AUC24h) Enzalutamide, M1,M2 and Enzalutamide Plus M2 [Time Frame: From randomization up to data cutoff date of 20 Jan 2016; Single Dosing Day 1]

Apparent Total Systemic Clearance After Multiple Dosing (CL/F) Enzalutamide, M1,M2 and Enzalutamide Plus M2 (For Unchanged Enzalutamide Only) [Time Frame: From randomization up to data cutoff date of 20 Jan 2016; Multiple Dosing Day 85]

Maximum Observed Plasma Concentration During the First 24 Hours After Dosing (Cmax) Enzalutamide, M1,M2 and Enzalutamide Plus M2 [Time Frame: From randomization up to data cutoff date of 20 Jan 2016; Single Dosing Day 1 and Multiple Dosing Day 85]

Duration of Overall Survival [Time Frame: From randomization up to data cutoff date of 04 Nov 2020; median follow-up time is 21.9 months for enzalutamide and 7.29 months for placebo]

Number of Participants With Confirmed Best PSA Response (=50% Decrease From Baseline) [Time Frame: Baseline up to data cut off date of 20 Sept 2015; median treatment duration is 6.60 months for enzalutamide and 3.70 months for placebo]

Time to Maximum Concentration (Tmax) of Enzalutamide, M1,M2 and Enzalutamide Plus M2 [Time Frame: From randomization up to data cutoff date of 20 Jan 2016; Single Dosing Day 1 and Multiple Dosing Day 85]

Observed Plasma Concentration in Predose Samples Obtained During Multiple-dose Administration of Minimum Concentration (Plasma Concentration at Pre Dose) (Cmin) Enzalutamide, M1,M2 and Enzalutamide Plus M2 [Time Frame: From randomization up to data cutoff date of 20 Jan 2016; Day 2, 3, 8, 22, 29, 43, 57, 85, 86, 113, 141 and 169]

Duration of Radiographic Progression-free Survival (rPFS) Based on Independent Central Review Facility Assessment [Time Frame: From randomization up to data cutoff date of 20 Sept 2015; median follow-up time is 5.55 months for enzalutamide and 3.71 months for placebo]

Time to First Skeletal-Related Event [Time Frame: From randomization up to data cutoff date of 20 Sept 2015; median follow-up time is 7.39 months for enzalutamide and 5.29 months for placebo]

Time to Initiation of Cytotoxic Chemotherapy [Time Frame: From randomization up to data cutoff date of 20 Sept 2015; median follow-up time is 7.39 months for enzalutamide and 4.93 months for placebo]

AUC From the Time of Dosing to the Start of the Next Dosing Interval (AUCtau) Enzalutamide, M1,M2 and Enzalutamide Plus M2 [Time Frame: From randomization up to data cutoff date of 20 Jan 2016; Multiple Dosing Day 85]

Peak-Trough Ratio (PTR) Enzalutamide, M1,M2 and Enzalutamide Plus M2 [Time Frame: From randomization up to data cutoff date of 20 Jan 2016; Multiple Dosing Day 85]

Best Overall Soft Tissue Response [Time Frame: From randomization up to data cut off date of 20 Sept 2015; median treatment duration is 6.60 months for enzalutamide and 3.70 months for placebo]

Concentration 24 h After Dosing (C24h) Enzalutamide, M1,M2 and Enzalutamide Plus M2 [Time Frame: From randomization up to data cutoff date of 20 Jan 2016; Single Dosing Day 1 and Multiple Dosing Day 85]

Secondary ID(s)

CTR20140131

9785-CL-0232

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 12/04/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02294461