NCT02125617终止不适用
uPAR in Blood From Zytiga® (Abiraterone) Treated Patients With Castration Resistant Prostate Cancer - a Predictive Marker of Response?
Kristoffer Rohrberg1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2014年1月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Impact of baseline uPAR cleavage products on response.
研究概览
简要总结
The purpose of this study is to investigate cleavage products of the urokinase plasminogenactivator receptor (uPAR) in plasma from patients with castration resistant prostate cancer as a predictive marker of response to abiraterone.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent.
- •Age ≥18 years and male
- •Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology
- •Received at least one but not more than two cytotoxic chemotherapy regimens for metastatic CRPC. At least one regimen must have contained a taxane such as docetaxel.
- •Prostate cancer progression as assessed by the investigator with one of the following:
- •PSA progression according to Prostate Cancer Working Group 2 (PCWG2) criteria
- •Solid Tumors (RECIST) criteria or bone scans with or without PSA progression.
- •Radiographic progression in soft tissue according to Response Evaluation Criteria in
- •Ongoing androgen deprivation with serum testosterone <2.0 nM
- •Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
- •Platelet count ≥100,000/μL
- •Serum albumin ≥30 g/dL
- •Serum creatinine <1.5 x upper limit of normal (ULN) or a calculated creatinine clearance ≥ 60 mL/min
- •Serum potassium ≥3.5 mmol/L
排除标准
- •Received abiraterone or MDV3100 in the past.
- •Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection.
- •Abnormal liver functions consisting of any of the following:
- •Serum bilirubin ≥1.5 x ULN (except for subjects with documented Gilbert's disease, for whom the upper limit of serum bilirubin is 51 µmol/l)
- •Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥2.5 x ULN
- •Uncontrolled hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥95 mmHg); subjects with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive therapy.
- •Active or symptomatic viral hepatitis or chronic liver disease
- •History of pituitary or adrenal dysfunction
- •Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class III or IV heart disease or left ventricular ejection fraction (LVEF) of <50% at baseline.
- •Known brain metastasis
- •History of gastrointestinal disorders (medical disorders or extensive surgery) that may interfere with the absorption of the study drug
- •Any acute toxicities due to prior chemotherapy or radiotherapy that have not resolved to a NCI-CTCAE (Version 4.0) Grade of ≤
- •Chemotherapy induced alopecia and Grade 2 peripheral neuropathy is allowed.
- •Use of other anticancer therapy including cytotoxic, radionucleotide, and immunotherapy; diethylstilbestrol; PC-SPES; spironolactone (ie, ALDACTONE, SPIRONOL); and other preparations such as saw palmetto thought to have endocrine effects on prostate cancer, within 4 weeks of Cycle 1 Day 1
- •Prior systemic treatment with an azole drug (eg, fluconazole, itraconazole, ketoconazole) within 4 weeks of Cycle 1 Day 1
- •Current enrolment in an investigational drug or device study or participation in such a study within 30 days of Day 1
- •Condition or situation which, in the investigator's opinion, may put the subjects at significant risk, may confound the study results, or may interfere significantly with subject's participation in the study.
研究组 & 干预措施
Castration-resistant prostate cancer, Progression after taxane
Treated with abiraterone 1000 mg/day Prednisolone 10 mg/day
干预措施: Prednisolone (Drug)
Castration-resistant prostate cancer, Progression after taxane
Treated with abiraterone 1000 mg/day Prednisolone 10 mg/day
干预措施: Abiraterone (Drug)
结局指标
主要结局
Impact of baseline uPAR cleavage products on response.
时间窗: 6 months
Impact of baseline plasma concentration of uPAR cleavage products on overall response rate (ORR) defined as the proportion of patients with radiologic response according to the RECIST criteria or PSA-response.
次要结局
- Impact of baseline plasma concentration of uPAR cleavage products on pain relief rate.(6 months)
- Impact of baseline plasma concentration of uPAR cleavage products on serious adverse events (SAE).(6 months)
- Impact of baseline plasma concentration of uPAR cleavage products on overall survival (OS).(6 months)
- Impact of baseline plasma concentration of uPAR cleavage products on progression free survival (PFS).(6 months)
- Impact of baseline plasma concentration of uPAR cleavage products on disease control rate (DCR).(6 months)
研究者
Kristoffer Rohrberg
MD, Phd
Rigshospitalet, Denmark
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Urokinase-type Plasminogen Activator Receptor and Gastroesophageal CancerEsophagus Cancer, AdenocarcinomaNCT04669951Michael Patrick Achiam100
终止
2 期
uPAR PET/CT in Radium-223-dichloride Treatment of Patients With Metastatic Castration-resistant Prostate CancerBone MetastasesProstate Cancer MetastaticNCT02964988Rigshospitalet, Denmark17
已完成
1 期
Urokinase-Plasminogen Activator (uPA) Inhibitor WX-UK1 in Combination With Capecitabine in Advanced MalignanciesAdvanced MalignanciesNCT00083525Heidelberg Pharma AG33
已完成
不适用
Urokinase Plasminogen Activator System in Benign Prostatic HyperplasiaBPHNCT00407329Queen's University30
已完成
不适用
suPAR is a Potential Biomarker of in Chronic Periodontitis Through the Impact of Post-radiotherapy on HNCs PatientsComplications RadiotherapyChronic PeriodontitisHead and Neck CancerNCT06481059Al-Maarif University College150