EUCTR2012-005194-32-BE进行中（未招募）不适用
A phase II trial evaluating Cabazitaxel in patients with brain metastasis secondary to breast and non-small-cell lung cancer - CRANIA
Institut Jules Bordet0 个研究点开始时间: 2013年6月5日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- All
入选标准
- •- Signed informed consent
- •- Age>18, ECOG 0-1
- •- Histologically confirmed 1) HER2-negative invasive breast carcinoma or 2) NSCLC
- •- In patients with breast cancer, HER2-negative status by FISH or immunohistochemistry (score 0, or +1).
- •- In patients with breast cancer, known estrogen and progesterone receptor status.
- •- Evidence of measurable disease in the brain (at least 1cm)
- •- Stable or decreasing dosage of steroids for 7 days prior to baseline MRI.
- •- No evidence of (cortical) cognitive impairment as defined by a Mini-Mental Status Exam (MMSE)
- •score = 25/30.
- •- No more than 4 prior lines of systemic chemotherapy in the metastatic setting
- •- Adequate hematopoietic function defined as:
- •Hemoglobin = 9.0g/dL
- •Absolute neutrophilic count = 1.5 x 109L
- •Platelet count = 100 x 109L
- •- Adequate hepatic function defined as:
- •AST = 2.5 x upper limit of normal (ULN)
- •ALT = 2.5 x ULN
- •Total bilirubin = 1.0 x ULN
- •- Adequate renal function defined as serum creatinine = 1.5 x ULN. If creatinine ranges from 1.0 – 1.5 x ULN, creatinine clearance determined by CKD-EPI formula should be calculated and only patients with clearance >60 mL/min are eligible
- •- Adequate contraceptive method in patients with child-bearing potential.
- •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 37
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- History of prior whole brain irradiation
- •- Progressive neurological symptoms requiring immediate brain irradiation
- •- Pregnancy or lactation
- •- History of hypersensitivity reaction to taxanes
- •- History of hypersensitivity to polysorbate 80 containing agents
- •- Current or planned treatment with strong inhibitors or inducers of cytochrome P450.
- •- Less than 3 weeks since the last treatment of chemotherapy, biological therapy, and/or
- •immunotherapy
- •- Leptomeningeal carcinomatosis
- •- Contra-indication to contrast-enhanced MRI
研究者
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