EUCTR2013-005545-37-DE进行中（未招募）1 期
A Phase II Study of Cabazitaxel for Patients with Breast or Lung Cancer and Recurrent or Progressive Brain Metastases (CaBaMet) - CaBaMet
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
- •- Adult patients (= 18 years of age)
- •- Histologically or cytologically confirmed stage IV lung or breast cancer with progressive or recurrent brain metastases
- •- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •- Prior external beam radiotherapy (WBRT or SRS) of BM. Patients suffering from small cell lung cancer (SCLC) who have been treated with chemotherapy and prophylactic cranial radiotherapy may be also enrolled.
- •- At least one two-dimensional measurable lesion on brain MRI
- •- Life expectancy at least 3 months
- •- Females of childbearing potential (FCBP) must have a negative pregnancy test within 7 days of the first application of study treatment
- •and must agree to use effective contraceptive birth control measures (Pearl Index < 1) during the course of the trial
- •A female subject is considered to be of childbearing potential unless she is age = 50 years and naturally amenorrhoeic for = 2 year, or unless she is surgically sterile.
- •- Males must agree to use effective contraception (Pearl Index < 1) during the course of the trial and for at least 6 months after last administration of study medication cabazitaxel. In addition males must agree to prevent contact with the ejaculate by another person throughout study treatment.
- •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
- •- Prior chemotherapy or targeted therapy (e.g. erlotinib, bevacizumab) for brain metastases
- •- Any chemotherapy or targeted tumor therapy within two weeks of study inclusion or concomitantly
- •- Any antihormonal tumor treatment within two weeks of study inclusion or concomitantly
- •- Time interval to prior external beam radiotherapy less than 2 weeks
- •- Suspected or known leptomeningeal disease
- •- Peripheral neuropathy = grade 2
- •- Inadequate organ and bone marrow function as evidenced by:
- •- Absolute neutrophil count (ANC) < 1.5 x 10*9/L
- •- Hemoglobin < 10.0 g/dL
- •- Platelet count < 100 x 10*9/L
- •- Total bilirubin = 1 x upper limit of normal (ULN)
- •- AST/GOT and/or ALT/GPT = 1.5 x ULN
- •- Serum creatinine > 1.5 x ULN. If creatinine 1.0 - 1.5 x ULN, creatinine clearance has to be calculated according to CKD-EPI formula and patients with creatinine clearance < 60 mL/min must be excluded
- •- Other inadequate organ function according to investigator’s discretion
- •- History of hypersensitivity reaction to docetaxel
- •- History of hypersensitivity reaction to polysorbate 80 containing drugs
- •- Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus)
- •- Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who are already on these treatments; dexamethasone is allowed)
- •- Recently received or planned vaccination against yellow fever during study treatment
- •- Pregnant or breast feeding females
- •- Participation in any other clinical trial or treatment with any experimental drug within 28 day before enrolment to the study or during study participation until the end of treatment visit
- •- Previous or concurrent tumor other than underlying tumor disease (breast or lung cancer) with the exception of cervical cancer in situ, adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, superficial bladder tumors (Ta,Tis, and T1) or any curatively treated tumors > 5 years prior to enrolment
研究者
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