EUCTR2013-002271-17-DE进行中（未招募）1 期
A Multi-center, Single Arm Study of Enzalutamide in Patients with Progressive Metastatic Castration-Resistant Prostate Cancer Previously Treated With Abiraterone Acetate
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
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
- •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
- •XML File Identifier: wZQnigOofWBpwCRGfMUlPL+KuoA=
- •abiraterone acetate within its approved label indication 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
- •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:
- •The score on BPI-SF Question #3 must be < 4.
- •No use of opiate analgesics for prostate cancer-related pain currently
- •or anytime within 4 weeks prior to screening.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 75
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 125
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.
研究者
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