A Phase 2, Multicenter, Single-arm, Open Label Study to Monitor the Safety of Enzalutamide in Patients With Progressive Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy

Astellas Pharma Europe B.V.4 sites in 2 countries30 target enrollmentSeptember 23, 2014

ConditionsCastration-Resistant Prostate Cancer Prostate Cancer

InterventionsEnzalutamide

DrugsEnzalutamide

Overview

Phase: Phase 2
Intervention: Enzalutamide
Conditions: Castration-Resistant Prostate Cancer
Sponsor: Astellas Pharma Europe B.V.
Enrollment: 30
Locations: 4
Primary Endpoint: Safety profile of enzalutamide assessed by adverse events (AEs), serious AEs (SAEs), vital signs, electrocardiograms (ECGs) and laboratory measurements
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to monitor the safety of enzalutamide in patients with progressive castration-resistant prostate cancer previously treated with docetaxel-based chemotherapy.

Registry

clinicaltrials.gov

Start Date

September 23, 2014

End Date

May 25, 2017

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Astellas Pharma Europe B.V.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject has histologically or cytologically confirmed adenocarcinoma of the prostate
•Subject has ongoing androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) analogue (agonist or antagonist) and plans to maintain throughout the study period or has had a prior orchiectomy (i.e., surgical or medical castration)
•Subject has had at least one prior chemotherapy regimen for metastatic castration-resistant prostate cancer with at least one regimen containing docetaxel
•Subject has progressive disease and indication for change of antineoplastic regimen
•Subject has no known or suspected brain metastasis
•Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
•Subject is able to swallow the study drug and comply with study requirements
•There is no comparable or satisfactory alternative therapy to treat the subject's disease
•Subject agrees not to participate in another interventional study while on treatment

Exclusion Criteria

•Subject has severe concurrent disease, infection, or co-morbidity that would make the subject inappropriate for enrollment
•Subject's absolute neutrophil count is \< 1000/μL, or platelet count \< 100,000/μL, or hemoglobin \< 6.2 mmol/L (or \< 10 g/dL)
•Subject's total bilirubin is ≥ 1.5 x upper limit of normal (ULN) (except for subjects with documented Gilbert's disease) or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) is ≥ 2.5x ULN
•Subject's estimated creatinine clearance is less than 30 mL/min by the Cockcroft and Gault formula
•Subject has albumin ≤ 30 g/L (or ≤ 3.0 g/dL)
•Subject has received anti-androgen therapy (e.g. bicalutamide), chemotherapy, or biologic therapy for prostate cancer (other than bone targeted agents such as bisphosphonates or denosumab, gonadotropin-releasing hormone (GnRH) analogue therapy, or glucocorticoids which are allowed) within 4 weeks of Day 1
•Subject has had prior use of abiraterone
•Subject has prior use, or participation in a clinical trial, of an investigational agent that blocks androgen synthesis (e.g. TAK-700) or targets the androgen receptor (e.g. ARN-509, ODM-201)
•Subject has:
•A history of seizure, including any febrile seizure or any condition that may predispose to seizure including, but not limited to underlying brain injury, stroke, primary brain tumors, brain metastases,

Arms & Interventions

Enzalutamide

Intervention: Enzalutamide

Outcomes

Primary Outcomes

Safety profile of enzalutamide assessed by adverse events (AEs), serious AEs (SAEs), vital signs, electrocardiograms (ECGs) and laboratory measurements

Time Frame: Up to 30 days after the last dose of enzalutamide or prior to the initiation of another anticancer therapy, whichever comes first (up to 18 months)