Overview

This trial is active, not recruiting.

Condition progressive metastatic prostate cancer
Treatments enzalutamide, placebo
Phase phase 3
Target androgen receptor
Sponsor Astellas Pharma Inc
Start date April 2014
End date September 2015
Trial size 420 participants
Trial identifier NCT02294461, 9785-CL-0232

Summary

Purpose of the study is to assess the effect of enzalutamide on time to Prostate Specific Antigen (PSA) progression as compared to placebo in chemotherapy naïve subjects with progressive metastatic prostate cancer who have failed androgen deprivation therapy

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Oral
enzalutamide Xtandi
oral
(Placebo Comparator)
Oral
placebo
oral

Primary Outcomes

Measure
Time to PSA progression
time frame: Up to 16.3 months

Secondary Outcomes

Measure
duration of radiographic progression free survival
time frame: up to 41 weeks
duration of overall survival
time frame: up to 41 weeks
Safety assessed by the incidence of adverse events, laboratory tests, vital signs, physical examinations and 12-lead ECG.
time frame: up to 41 weeks
Pharmacokinetic Analysis of enzalutamide and major metabolites (tmax)
time frame: Day 1, Day 85
Pharmacokinetic Analysis of enzalutamide and major metabolites (Cmax)
time frame: Day 1, Day 85
Pharmacokinetic Analysis of enzalutamide and major metabolites (AUC)
time frame: Day 1, Day 85
Pharmacokinetic Analysis of enzalutamide and major metabolites (Cmin)
time frame: Day 2, 3, 8, 22, 29, 43, 57, 85, 86, 113, 141 and 169
CL/F of enzalutamide
time frame: Day 85
Peak-trough ratio (PTR) of enzalutamide and major metabolites
time frame: Day 85

Eligibility Criteria

Male participants at least 18 years old.

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).

Additional Information

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
Description This study is a multinational Phase 3, randomized, double-blind, placebo-controlled efficacy and safety study of oral enzalutamide (formerly MDV3100) in asymptomatic or mildly symptomatic subjects with progressive metastatic prostate cancer who have disease progression despite androgen deprivation therapy. Subjects must not have been previously treated with cytotoxic chemotherapy. Approximately 30 Chinese subjects will be allocated to the PK cohort. The subjects in PK cohort will be requested to be hospitalized from one day before the date of randomization to at least the completion of all the assessments planned on Day 3. All subjects in PK cohort will undergo blood sampling for PK analysis of unchanged enzalutamide and its major metabolites regardless of treatment arm.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Astellas Pharma Inc.