EUCTR2011-004178-27-SE进行中（未招募）1 期
A Randomized, Open Label, Multicenter, Phase II, 2-Arm Study comparing the conventional 3 weekly schedule of Jevtana (Cabazitaxel) with a weekly regimen in patients with Metastastic Castration Resistant Prostate CancerConWeCab - ConCab
Karolinska University Hospital0 个研究点目标入组 130 人开始时间: 2011年12月19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）
- 发起方
- 入组人数
- 130
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
- •Written informed consent
- •Histological confirmed prostate cancer
- •Macroscopic metastatic disease
- •Prior treatment with Docetaxel
- •Castration resistant disease defined as :
- •Serum testosterone (< 0.5 ng/ml) and :
- •* Increase in measurable disease (Recist 1.1) Or
- •* Appearance of new lesions
- •* Rising PSA
- •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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 80
排除标准
- •Less than 21 days since prior treatment with chemotherapy,
- •Less than 14 days since radiotherapy or surgery to the start of cabazitaxel
- •Less than 4 weeks after stopping abiraterone or other new anti-hormonal drugs
- •Prior isotope therapy or radiotherapy to > 30% of bone marrow (whole pelvic radiotherapy is not an exclusion criteria)
- •Adverse events from previous cancer therapies > grade 1 (NCI CTCAE V4.03) with the exception of alopecia. (With respect to peripheral neuropathy grade 2 is acceptable)
- •Age less than 18 years
- •ECOG performance status > 2
- •Known CNS malignancy
- •Within 6 months of randomization: myocardial infarction , unstable angina, angioplasty, bypass surgery, stroke, TIA, or congestive heart failure NYHA class III or IV
- •Within 3 months prior to randomization: treatment resistant peptic ulcer disease, infectious or inflammatory bowel disease, pulmonary embolism
- •Any severe acute or chronic medical condition that places the patient at increased risk of serious toxicity or interferes with the interpretation of study results
- •Unable to comply with study procedures
- •History of hypersensitivity to docetaxel or polysorbate 80
- •Inadequate organ and bone marrow function as defined below
- •Concurrent or planned treatment with potent inhibitors or inducers of cytochrome P450 3A4/5 ( eg simvastatin, keotconazole. For comprehensive list please see Appendix ) a one week wash out period is necessary for patients who are already on these treatments).
- •Patients with reproductive potential not implementing accepted and effective method of contraception.
研究者
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