EUCTR2010-021128-92-GB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
- 981
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.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 arrhythmias, angina pectoris, hypertension or uncontrolled diabetes mellitus). History of congestive 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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