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 - ND

sanofi-aventis Groupe0 个研究点目标入组 1,000 人开始时间: 2010年11月19日最近更新: 2014年6月30日

适应症

试验速览

暂无简介。

•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; 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

•1. Prior radiotherapy to >= 40% of bone marrow; 2. Prior radionuclide therapy (samarium-153, strontium-89, P-2); 3. Prior surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior to enrollment; 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 diabetes mellitus); 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. Participation in a clinical trial with any investigational drug; 15. Patient with reproductive potential not implementing accepted and effective method of contraception

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