NCT02656615终止2 期
An Open Label Biomarker Driven Phase II Clinical Trial of Abiraterone Acetate (AA) Re-Challenge in Patients With Metastatic Castration-Resistant Prostate Cancer and Prior Response to AA
Aurelius Omlin3 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2016年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 3
- 主要终点
- Response rate
研究概览
简要总结
To assess activity of abiraterone-re-challenge in patients with advanced prostate cancer and prior response to abiraterone.
详细描述
To assess activity of abiraterone-re-challenge in patients with advanced prostate cancer and prior response to abiraterone. CRPC patients with prior response to abiraterone (confirmed PSA Response) and progression can be re-challenged with abiraterone. Patients may have received treatment with docetaxel, enzalutamide and radium-223.
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 100 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Written prostate cancer.
- •Adult patients with histological or cytological diagnosis of adenocarcinoma of the prostate.
- •Men with castration-resistant metastatic decline maintained for at least 3 weeks as per PCWG2 criteria).
- •Confirmed biochemical response to prior abiraterone acetate (≥50% PSA Informed Consent (including consent for biomarker studies including the fresh tumour biopsies)
- •Progressive disease according to PCWG2 criteria during prior therapy with standard dose of abiraterone acetate (confirmed increase of PSA ≥25% over nadir) or soft-tissue or bone progression. Patients that have stopped abiraterone acetate for reasons other than progression are not eligible.
- •Documented progression of disease by any of the criteria listed here:
- •Soft tissue
- •Bone scan all as per PCWG2 criteria
- •Patients may have received treatment with docetaxel, enzalutamide or radium-223
- •PSA of ≥10ug/l
- •ECOG performance status 0 - 2
- •At least 3 months (90 days) since stop of prior abiraterone acetate.
排除标准
- •Major surgery within 28 days weeks prior to start of treatment
- •Prior treatment with cabazitaxel or the CYP-17 inhibitor TAK-700/orteronel
- •Any concurrent treatment or prior treatment with an investigational drug within 28 days prior to start of treatment.
- •Known brain or leptomeningeal disease
- •Concurrent use of steroids other than prednisone >10mg/d
- •Inadequate bone marrow and organ function as evidenced by:
- •Platelet count <75 x 10 G/L ASAT and/or ALAT ≥ 2.5 x ULN Total bilirubin ≥ 1.5 x ULN (≥ 2.0 x ULN for patients with Gilbert's disease) Hypokalaemia despite adequate supplementation Creatinine Clearance <30ml/min
- •Uncontrolled hypertension or cardiac failure or LVEF <50%
- •creatinine clearance is to be calculated by using the formula of Cockcroft-Gault in appendix 4 of the protocol
研究组 & 干预措施
Abiraterone
Experimental
Abiraterone acetate 1000 mg once daily and Prednisone 2x5 mg daily (continuously as per prescription label).
干预措施: abiraterone acetate (Drug)
结局指标
主要结局
Response rate
时间窗: at week 12
Soft-tissue and PSA Response per PCWG2
次要结局
- Rate of PSA decline 30%(at week 12)
- Disease control rate(at 12 and 24 weeks)
- Rate of CTC conversion(Measured at baseline and at 12 weeks)
- rPFS(From date of start of treatment up to 6 months)
研究者
Aurelius Omlin
MD
Cantonal Hospital of St. Gallen
研究点 (3)
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