A Study to Monitor the Safety of Enzalutamide in Patients With Progressive Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy

Astellas

Status and phase

Completed

Phase 2

Conditions

Castration-Resistant Prostate Cancer

Prostate Cancer

Treatments

Drug: Enzalutamide

Study type

Interventional

Funder types

Industry

Identifiers

NCT02124668

9785-CL-0122

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

Male

Volunteers

No Healthy Volunteers

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:
1. 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,
2. A history of loss of consciousness or transient ischemic attack within 12 months of Screening
Subject has clinical signs suggestive of high or imminent risks for pathological fracture, spinal cord compression and/or cauda equina syndrome
Subject has a significant cardiovascular disease
Subject has received investigational therapy within 28 days or 5 half lives, whichever is longer, prior to Screening
Subject has undergone major surgery within 4 weeks prior to Screening
Subject has shown a hypersensitivity reaction to the active pharmaceutical ingredient or any of the capsule components, including Labrasol, butylated hydroxyanisole, and butylated hydroxytoluene
Subject has used or plans to use, from 30 days prior to enrollment through the end of the study, medications known to lower the seizure threshold or prolong the QT interval