NCT02429193已完成2 期
An Open-label Phase 2 Multi-center Study of Enzalutamide and Abiraterone and Biomarkers of Androgen Response and Resistance During Rising PSA: BARRIER-P Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Change in expression of androgen receptor abnormalities (e.g. ARV7, AR mutations) following abiraterone/enzalutamide treatment
研究概览
简要总结
This is an open-label phase 2 multi-center study of abiraterone and enzalutamide in men with castration-resistant prostate cancer. Sixteen patients will be enrolled over 18 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically or cytologically confirmed prostate cancer
- •Able to read and understand the consent form, either alone or with the aid of a translator
- •Surgically or medically castrated, with testosterone levels of < 50 ng/dL (< 2.0 nmol/L). If the patient is being treated with luteinizing hormone-releasing hormone (LHRH) agonists (patients who have not undergone orchiectomy), they must remain on continuous androgen suppression therapy throughout the study
- •Patients receiving bone-targeted therapies must be on stable doses for at least 4 weeks prior to enrollment
- •Historical frozen/paraffin-embedded diagnostic tissue specimens are available for analysis (i.e. radical prostatectomy or biopsy tissue)
- •Documented metastatic disease by positive bone scan or metastatic lesions (on CT or MRI) that can be biopsied with an anticipated minimum of 4 cores, as assessed by the local radiologist
- •prostate cancer progression at study entry defined as one or more of the following criteria: i. Rising PSA: minimum of two rising PSA levels with an interval of ≥ 1 week between each determination ii. Soft tissue disease progression, as defined by RECIST 1.1 iii. Bone disease progression, as defined by PCWG2 with two or more new lesions on bone scan
- •PSA value at screening visit ≥ 2 µg/L (2 ng/mL)
- •ECOG performance status 0-2
- •Adequate organ and BM function, as defined by the following criteria:
- •i. absolute neutrophil count ≥1,500/µL ii. platelets ≥100,000/µL iii. total bilirubin ≤1.5 × institutional upper limit of normal (ULN) iv. AST(SGOT) or ALT(SGPT) ≤2.5 × institutional ULN v. creatinine ≤1.5 × institutional ULN or below
- •Serum albumin ≥ 3.0 g/dL
- •Serum potassium ≥ 3.5 mmol/L
- •Haemoglobin ≥ 10.0 g/dL, independent of transfusion
- •Asymptomatic or mildly symptomatic from prostate cancer
- •Life expectancy of > 6 months
- •Able to swallow study drugs
- •Patients who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator and sponsor during the study and for 13 weeks after last study drug administration
排除标准
- •Patients with known hypersensitivity or allergy to abiraterone acetate, enzalutamide or any of their excipients.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, congestive heart failure (NYHA Class 3 or greater), cirrhosis with a Child-Pugh level of B or greater or evidence of cardiac dysfunction, unstable angina pectoris, cardiac arrhythmia, myocardial infarction within 6 months, hypotension (defined by systolic blood pressure < 86 mmHg at Screening visit), hypertension (defined by systolic blood pressure > 170 mmHg or diastolic blood pressure > 105 mmHg at Screening visit), bradycardia (defined by < 50 beats per minute on ECG performed at screening), active peptic ulcer disease, clinically significant gastrointestinal conditions (e.g. Crohns disease, ulcerative colitis), any seizure disorder or psychiatric illness, and social situations that would limit compliance with study requirements
- •Active invasive malignancy at any other site excluding squamous cell or basal cell carcinomas of the skin
- •Known or suspected brain metastasis or leptomeningeal disease
- •Radiotherapy within the past 4 weeks, except for low dose palliative radiation to bone of ≤5 fractions
- •Treatment with 5-α reductase inhibitors (finasteride, dutasteride), androgen receptor antagonists (bicalutamide, nilutamide, flutamide), estrogens, cyproterone within 4 weeks of Day 1 visit
研究组 & 干预措施
Abiraterone / enzalutamide
Experimental
Abiraterone + prednisone; Enzalutamide
干预措施: Abiraterone + prednisone (Drug)
Abiraterone / enzalutamide
Experimental
Abiraterone + prednisone; Enzalutamide
干预措施: Enzalutamide (Drug)
结局指标
主要结局
Change in expression of androgen receptor abnormalities (e.g. ARV7, AR mutations) following abiraterone/enzalutamide treatment
时间窗: 18 months
The change in protein expression of androgen receptor (AR7) splice variant and AR / AR pathway mutations as a mechanism of resistance to abiraterone/enzalutamide is evaluated by measuring the difference in a quantitative immunohistochemical biomarker between assays performed before and after treatment.
次要结局
- Rate of PSA increase(18 months)
- Time to PSA progression(18 months)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
A Study for Participants With Relapsed Cutaneous T-Cell LymphomaCutaneous T-Cell LymphomaNCT00744991Eli Lilly and Company25
已完成
2 期
Enzalutamide Versus Standard Androgen Deprivation Therapy for the Treatment Hormone Sensitive Prostate CancerAdenocarcinoma of the ProstateRecurrent Prostate CancerStage III Prostate CancerStage IV Prostate CancerNCT02278185University of Colorado, Denver19
已完成
2 期
A Phase II Study Evaluating the Efficacy of Enzalutamide and the Role of ARv7 in Metastatic Castration Resistant Prostate Cancer (mCRPC) Patients With Visceral Disease.Carcinoma ProstateNCT03103724Fondazione IRCCS Istituto Nazionale dei Tumori, Milano68
已完成
2 期
Enzalutamide/Leuprolide +/- Abiraterone/Pred in ProstateProstate AdenocarcinomaHigh Risk Prostate CancerProstate CancerNCT02268175Dana-Farber Cancer Institute75
已完成
2 期
Open Label Phase Two Study of Enzalutamide With Concurrent Administration of Radium Ra 223 Dichloride in Castration-Resistant (Hormone-Refractory) Prostate Cancer Subjects With Symptomatic Bone MetastasisProstate Carcinoma Metastatic to the BoneNCT02507570Carolina Research Professionals, LLC40