EUCTR2014-003192-28-ES进行中（未招募）1 期
Phase II multicenter study to analyze the predictive value of fusion gene TMPRSS2-ETS in response to enzalutamide in patients with metastatic CRPC no previously treated with chemotherapy - PREMIERE
SOGUG0 个研究点目标入组 98 人开始时间: 2014年11月4日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 98
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
入选标准
- •1. Patients aged 18 years and above, willing and able to provide written informed consent.
- •2. Prostate adenocarcinoma with histological or cytological confirmation without neuroendocrine differentiation nor small cell characteristics
- •3. Androgen deprivation therapy with GnRH analogs or bilateral orchiectomy (pharmacological or surgical castration). Patients without bilateral orchiectomy must follow a GnRH analog therapy during the trial.
- •4. Testosterone serum level <= 1,73 nmol/L (50 ng/dL) in screening visit.
- •5. Patients under bisphosphonate therapy must have received stable doses for the last 4 weeks.
- •6. Progression disease at inclusion, defined by one or more of the following three criteria during androgen deprivation therapy (according with the criterion nº 3):
- •- PSA progression defined as two elevation of the PSA serum level with >=1 week between each measure. Patients who have received an antiandrogen must present disease progression (>=4 weeks since the last dose of flutamide or >=6 weeks since the last dose of bicalutamide or nilutamide). PSA value in screening visit must be >=2 µg/L (2 ng/mL).
- •- Soft tissue progression defined by RECIST 1.1 criteria
- •- Bone lesion progresión defined by PCWG2 criteria, with two or more new lesions in a scintigraphy
- •7. Metastatic disease with bone lesions detected by scintigraphy, or measurable soft tissue lesions by CT/MR. Patients with ganglionar disease will be suitable if they have at least one ganglionar lesion with smallest diameter > 2,5 cm.
- •8. Patients without previous cytotoxic chemotherapy for prostate cancer
- •9. Patients without previous abiraterone acetate therapy for prostate cancer
- •10. Asymptomatic patient or mild symptomatic about prostate cancer, (answer in the question nº 3 of the Brief Pain Inventory Short From < 4)
- •11. ECOG = 0-1.
- •12. Life expectancy of at least 6 months
- •13. Patient must be able to swallow the investigation product and to follow the protocol requirements.
- •14. Biomarker study informed consent
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 68
排除标准
- •1. Active infection or other medical condition which, in the opinion of the investigator, would preclude participation in this trial.
- •2. Known brain metástasis or leptomeningeal active involvement
- •3. Other malignancy in the last five years, except non-melanoma skin cancer treated and resolved.
- •4. Hematologic parameters:
- •- Absolute neutrophil count <=1500/µL
- •- Platelet count <100 000/µL
- •- Haemoglobin < 5,6 mmol/L (9 g/dL)
- •5. Liver function: Serum bilirrubin, ALT or AST > 2,5 x ULN
- •6. Renal function: Creatinine >177 µmol/L (2 mg/dL).
- •7. Serum albumin <30 g/L (3,0 g/dL)
- •8. History of epilepsy or other medical condition which could cause an epileptic crisis as syncope or transient ischemic attack in the last twelve months.
- •9. Clinically significant cardiovascular disease, including:
- •- Myocardial infarction in the last 6 months
- •- Severe or unstable angina in the last 3 months
- •- New York Heart Association (NYHA) Class II-IV heart disease unless cardiac ejection fraction measurement of >=45% at 3 previous months
- •- History of clinically significant ventricular arrhythmia
- •- History of second degree AV bock or third degree AV block without permanent pacemaker
- •- Hypotension determined by a baseline systolic blood pressure < 86 mmHg
- •- Bradycardia detemined by heart rate < 50 BPM in baseline ECG
- •- Uncontrolled hypertension (systolic BP > 170 mmHg or diastolic BP > 105 mmHg).
- •10. Known gastrointestinal (GI) disease that could interfere with the GI absorption.
- •11. Significant surgery within 4 weeks before enrollment.
- •12. Use of opioids to control cancer pain within 4 weeks before enrollment.
- •13. Radiation therapy for treatment of the primary tumor in the last 3 weeks before enrollment
- •14. Radiation therapy for treatment of metastases in the last two months
- •15. Radionuclide therapy for treatment of bone metastasis
- •16. Prior flutamide treatment within 4 weeks before enrollment
- •17. Bicalutamide or nilutamide therapy within 6 weeks before enrollment
- •18. 5-a reductase inhibitors, estrogen o ciproterone therapy within 4 weeks before enrollment
- •19. Biologic therapy or other antitumoral drugs for the treatment of CRPC in the last 4 weeks
- •20. History of cancer progression with ketokonazol
- •21. Prior therapy or enrollment in a trial with an investigational product which blocks androgen synthesis (abiraterona, TAK-700, TAK-683, TAK-448) or blocks androgen receptors (ARN507, BMS 641988).
- •22. Included in a previous trial with enzalutamide (MDV3100).
- •23. Administration of an investigational drug in the last 4 weeks before enrollment
- •24. Use of phytotherapy products which hormonal activity against prostate cancer or which reduce PSA levels, or systemic corticosteroids in a dose greater than the equivalent of prednisone 10mg/day, within 4 weeks before enrollment
- •25. Hereditary fructose intolerance
- •26. Any condition which, in the opinion of the investigator, would preclude participation
研究者
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