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Metastatic hormone refractory prostate cancer previously treated with a docetaxel-containing regimenMedDRA version: 14.1 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
相关药物Jevtana
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Metastatic hormone refractory prostate cancer previously treated with a docetaxel-containing regimen
- 发起方
- sanofi-aventis groupe
- 入组人数
- 981
- 状态
- 进行中（未招募）
- 最后更新
- 6年前
概览
简要总结
暂无简介。
研究者
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:
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
结局指标
主要结局
未指定
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