A Multi-center, Single Arm Study of Enzalutamide in Patients with Progressive Metastatic Castration-Resistant Prostate Cancer Previously Treated With Abiraterone Acetate

Astellas Pharma Europe B.V.0 个研究点目标入组 200 人2014年2月13日

概览

阶段: 1 期
干预措施: 未指定
疾病 / 适应症: 未指定
发起方: Astellas Pharma Europe B.V.
入组人数: 200
状态: 进行中（未招募）
最后更新: 8年前

概览研究者入排标准结局指标相似试验

概览

简要总结

暂无简介。

注册库

who.int

开始日期

2014年2月13日

结束日期

待定

最后更新

8年前

研究类型

Interventional clinical trial of medicinal product

性别

Male

研究者

发起方

Astellas Pharma Europe B.V.

入排标准

入选标准

•1\. Subject has histologically confirmed adenocarcinoma of the prostate without neuro\-endocrine differentiation or small cell features.
•2\. Subject has metastatic disease documented by bone scan or by soft tissue disease observed by CT/MRI at screening, or within \= 30 days prior to Day 1\.
•3\. Subject has a serum testosterone of \= 1\.7 nmol/L (or \= 50 ng/dL) at screening.
•4\. In the setting of castrate levels of testosterone \=1\.7 nmol/L (or \=50 ng/dL), subject has progressive disease at study entry defined as PSA rise determined by a minimum of 2 rising PSA levels with an interval of \= 1 week between each assessment. The PSA value at the screening visit should be \= 2 ng/mL WITH or WITHOUT:
•Soft tissue disease progression defined by Response Evaluation Criteria In Solid Tumors (RECIST 1\.1\) at screening or within \= 30 days prior to Day 1\. Measurable disease is not required for entry. Lymph nodes \= 2 cm are considered measurable disease (PCWG2\).
•Bone disease progression defined by at least 2 new lesions on bone scan at screening or within \= 30 days prior to Day 1\.
•5\. Subject must have received a minimum of 24 weeks of treatment with abiraterone acetate and has discontinued use at least 4 weeks prior to start of study drug at Day 1\.
•6\. If the subject has received previous treatment with chemotherapy for prostate cancer, this must be limited to no more than one prior line of docetaxel, and must have been used prior to abiraterone acetate therapy.
•7\. Subject receives and will continue to receive ongoing androgen deprivation with LHRH analogue therapy throughout the course of the study or has had a bilateral orchiectomy.
•Subject is asymptomatic or mildly symptomatic from prostate cancer:

排除标准

•1\. Subject has prior use of ketoconazole for the treatment of prostate cancer.
•2\. Subject has prior use of cabazitaxel.
•3\. Subject has prior use of enzalutamide.
•4\. Subject has received ANY anti\-neoplastic therapy (including antiandrogens and chemotherapy) following abiraterone acetate discontinuation and prior to start of study drug at Day 1\.
•5\. Subject has a known or suspected hypersensitivity to enzalutamide, or any components of the formulation used.
•6\. Subject has known or suspected brain metastases or active leptomeningeal disease.
•7\. Subject has history of seizure or any condition that may predispose to seizure (e.g., prior stroke or significant brain trauma).
•8\. Subject has history of loss of consciousness or transient ischemic attack within 12 months of screening.
•9\. Subject has concurrent disease or any clinically significant abnormality following the investigator’s review of the physical examination, electrocardiogram (ECG) and safety laboratory tests at screening, which in the judgment of the investigator would interfere with the subject's participation in this study or evaluation of study results.
•10\. Subject has a history of another invasive cancer within 3 years prior to screening, with the exception of non\-melanoma skin cancers that have a remote probability of recurrence in the opinion of the Investigator in consultation with the medical monitor.