EUCTR2010-021128-92-CZ进行中（未招募）1 期
MULTICENTRE, SINGLE-ARM, OPEN LABEL CLINICAL TRIAL INTENDED TO PROVIDE EARLY ACCESS TO CABAZITAXEL IN PATIENTS WITH METASTATIC HORMONE REFRACTORY PROSTATE CANCER PREVIOUSLY TREATED WITH A DOCETAXEL-CONTAINING REGIMEN AND TO DOCUMENT SAFETY OF CABAZITAXEL IN THESE PATIENTS
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
- 1,000
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.Age =18 years
- •2.Metastatic Hormone Refractory Prostate Cancer previously treated with a docetaxel-containing regimen
- •3.Disease Progression during or after docetaxel-containing regimen for mHRPC
- •4.Surgical or medical castration
- •5.Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): 0-2
- •6.Life-expectancy =3 months
- •7.Adequate bone marrow, liver, and renal function: Neutrophils> 1500 /mm3; Hemoglobin > 10 g/dL; Platelets > 100 x109/L; Bilirubin < ULN; SGOT (AST) < 1.5xULN; SGPT (ALT) < 1.5xULN; Creatinine < 1.5xULN. If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated according to CKD-EPI formula and patients with creatinine clearance < 60 mL/min should be excluded (see Appendix C for formula).
- •8.Signed written informed consent obtained prior to enrolment.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Prior radiotherapy to = 40% of bone marrow
- •2.Prior radionuclide therapy with samarium-153 or P-32 within 8 weeks prior to enrollment or with strontium-89 or radium-223 within 12 weeks prior to enrollment
- •3. Prior surgery, radiation or chemotherapy within 4 weeks prior to enrolment (this 4-week wash-out period is aimed to allow the patient to recover from any side effects of previous therapy)
- •4.Active grade =2 peripheral neuropathy
- •5.Active grade =2 stomatitis
- •6.Active infection requiring systemic antibiotic or anti-fungal medication
- •7.Active cancer (other than mHRPC) including prior malignancy from which the patient has been disease-free for =5 years (except superficial basal cell skin cancer)
- •8.Known brain or leptomeningeal involvement
- •9.History of severe hypersensitivity reaction (=grade 3) to docetaxel
- •10.History of severe hypersensitivity reaction (=grade 3) to polysorbate 80 containing drugs
- •11.History of severe hypersensitivity reaction (=grade 3) or intolerance to prednisone or prednisolone
- •12.Uncontrolled severe illness or medical condition (including uncontrolled cardiac arrhytmias, angina pectoris, hypertension or diabetes mellitus). History of conqestive heart failure (NYHA III or IV) or myocardial infarction within last 6 months is also not allowed.
- •13.Concurrent or planned treatment with potent inhibitors or inducers of cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who are already on these treatments) (see Appendix A and B)
- •14. Treatment with any investigational drug within 4 weeks prior to enrolment
- •15.Patient with reproductive potential not implementing accepted and effective method of contraception
研究者
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