EUCTR2021-000520-35-IT进行中（未招募）1 期
Multiparametric assessment of bone response in mCRPC patients treated with Cabozantinib upon progression to chemotherapy and next generation hormonal agents: a phase II study - MERIDIA
AZIENDA SOCIO SANITARIA TERRITORIALE DEGLI SPEDALI CIVILI DI BRESCIA0 个研究点目标入组 30 人开始时间: 2021年6月8日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
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. Histological diagnosis of prostate carcinoma,
- •2. Age > 18 years,
- •3. Metastatic disease documented as the presence of bone lesions on bone scan associated or not to soft tissue lesions measurable at CT/RMN,
- •4. Eastern Cooperative Oncology Group (ECOG) performance status equal or less than 2
- •5. Expected life expectancy = 3 months,
- •6. Patients who have already received docetaxel, cabazitaxel and at least one next generation hormonal agent (abiraterone or enzalutamide) for metastatic disease (either hormone sensitive or castration resistant),
- •7. Subject capable to swallow the Study's medication and to comply with the Study's requirements,
- •8. Fertile patients and their partners must agree to use methods of contraception.
- •9. Signed 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 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •Presence of active serious disease, active infection or co-comorbidity that may prevent the study enrollment make
- •2. Known or suspected brain metastases or active leptomeningeal dissemination,
- •3. History of other malignant neoplasm during the previous 5 years, different from the non-melanoma skin carcinoma,
- •4. Absolute Neutrophil Count (ANC) < 1.500/µL, platelet < 100.000/µL, or hemoglobin < 5,6 mmol/L (< 9 g/dL) at Screening Visit (notably: patients must not receive neither any growth factor during the previous 7 days nor any blood transfusion during the 28 days preceding the hematology sampling performed at Screening),
- •5. Total bilirubin > 1,5 x ULN at Screening Visit,
- •6. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2,5 x ULN at Screening Visit,
- •7. Creatinine > 177 µmol/L (> 2 mg/dL) at Screening Visit,
- •8. Albumin = 30 g/L (= 3,0 g/dL) at Screening Visit,
- •9. Alkaline Phosphatase = 5 x ULN,
- •10. Prothrombin time / international normalized ratio (PT/INR) or partial thromboplastin time (PTT) test = 1.3 x the laboratory ULN,
- •11. Urine protein-to-creatinine ratio (UPCR) > 1 mg/mg (or 113.0 mg/mmol) or proteinuria > 1 g/24 h,
- •12. History of seizures or any other seizure-predisposed pathology; history of loss of consciousness or transitory ischaemic attack during the 12 months preceding the Screening visit,
- •13. Clinically significant cardiovascular disease including
- •- Myocardial infarction - Uncontrolled angina - Congestive heart failure New York Heart Association (NYHA) class 3 or 4, congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram or multi-gated acquisition scan performed within three months results in a left ventricular ejection fraction that is = 45%,- History of clinically significant ventricular arrhythmias
- •- History of long QT syndrome or corrected QT interval calculated by the Fridericia formula > 500 msec at Screening Visit,
- •- History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place,
- •- Hypotension as indicated by systolic blood pressure < 86 millimeters of mercury (mmHg) at the Screening visit,
- •- Bradycardia as indicated by a heart rate of < 50 beats per minute on the Screening ECG,
- •- Uncontrolled hypertension as indicated by systolic blood pressure > 170 mmHg or diastolic blood pressure > 105 mmHg at the Screening visit,
- •14. Gastrointestinal disorder affecting absorption
- •15. Major surgery within 4 weeks of enrollment
- •16. Concomitant therapy with anticoagulants
- •,17. Use of herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (e.g., saw palmetto) or systemic corticosteroids greater than the equivalent of 10 mg of prednisone per day within four weeks of enrollment
- •18. Bone antiresorptive drugs that are started within 4 weeks of enrollment Bone antiresorptive drugs are permitted if already ongoing before this time point. Patients will be stratified according to zoledronic acid/denosumab exposure.
- •19. Systemic treatment with radionuclides within 6 weeks before first dose of study treatment or radiotherapy on sites other than bone administrated within 4 weeks of enrollment (Day 1 Visit). Radiotherapy on bone administrated within 2 weeks of enrollment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible. Radiotherapy given with palliative intent will be permitted during study treatment.
- •20. Any condition or reason that, i
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