EUCTR2012-005096-13-NL进行中（未招募）不适用
Clinical and pharmacological feasibility study with 2B3-101 in patients with breast cancer and leptomeningeal metastases
the Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI-AvL)0 个研究点开始时间: 2012年11月21日最近更新:
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
- •1. Age = 18 years.
- •2. Radiological or cytological evidence of clinically symptomatic leptomeningeal metastases of breast cancer.
- •3. Stable or decreasing dosage of steroids (e.g.dexamethason) for 7 days prior to baseline MRI or non-enzyme inducing anti-epileptic drugs is allowed.
- •4. Concomitant brain metastases are allowed
- •5. Patients with pathologically confirmed diagnosis of advanced, recurrent breast cancer and unequivocal evidence of leptomeningeal metastases
- •6. ECOG Performance Status = 2.
- •7. Estimated life expectancy of at least 8 weeks.
- •8. Toxicities incurred as a result of previous anticancer therapy (radiation therapy, chemotherapy, or surgery) must be resolved to = grade 2 (as defined by CTCAE version 4.0).
- •9. Performed cognitive test for neurotoxicity
- •10. Written informed consent according to local guidelines.
- •11. Local radiation of CNS symptomatic sites more than four weeks prior to start of the study is allowed.
- •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 6
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Candidates will be excluded from study entry if any of the following exclusion criteria exist:
- •Prior Treatment:
- •1. Less than 4 weeks from the last treatment of chemotherapy, biological therapy, immunotherapy, endocrine therapy and less than 6 weeks for nitrosoureas and mitomycin C.
- •2. Less than 4 weeks from the last radiotherapy of the brain or spinal cord/cauda equina. Radiotherapy of the symptomatic bone metastases is allowed during 2B3-101 treatment but if they are located in the vertebral column, these radiated localisations cannot be used for response evaluation.
- •3. Patients that have received a maximum cumulative dose of free (i.e., non-liposomal) or liposomal doxorubicin > 360mg/m2 or free epirubicin > 600mg/m2
- •4. Current or recent (less than 4 weeks before first 2B3-101 treatment) treatment with another investigational drug.
- •5. Any other current anticancer therapy is not allowed, as there are no interaction data of combination of 2B3-101 with other anticancer agents.
- •Haematology, coagulation and biochemistry:
- •6. Inadequate bone marrow function: Absolute Neutrophil Count (ANC): < 1.5 x 109/L, or platelet count < 100 x 109/L or haemoglobin < 6 mmol/L.
- •7. Inadequate liver function, defined as:
- •Serum (total) bilirubin > 1.5 x the Upper Limit of Normal (ULN) for the institution if no liver metastases (> 2 x ULN in patients with liver metastases);
- •Aspartate Amino Transferase (ASAT) or Alanine Amino Transferase (ALAT) > 3 x ULN if no liver metastases (> 5x ULN in patients with liver metastases);
- •Alkaline phosphatase levels > 2.5 x ULN if no liver metastases (> 5 x ULN in patients with liver metastases, or > 10 x ULN in patients with bone metastases).
- •8. Inadequate renal function, defined as:
- •Serum creatinine clearance > 50 ml/min
- •9. Pregnancy or lactation. Serum pregnancy test to be performed within 7 days prior to study treatment start in case of childbearing potential, or within 14 days followed by a confirmatory urine pregnancy test within 7 days prior to study treatment start.
- •10. For female subjects of childbearing potential (defined as < 2 years after last menstruation and not surgically sterile) and male subjects who are not surgically sterile or with female partners of childbearing potential: absence of effective, non-hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal gel).
- •11. Major surgical procedure (including open biopsy, excluding central line IV and Port-a-cath) within 4 weeks prior to the first study treatment, or anticipation of the need for major surgery during the course of the study treatment.
- •12. Grade 3 or 4 motor, sensory, or cranial neuropathy symptoms (as defined by CTCAE version 4.0) caused by previous chemotherapy.
- •13. Uncontrolled hypertension (systolic > 150 mm Hg and/or diastolic >100mm Hg).
- •14. Clinically significant (i.e. active) cardiovascular disease defined as:
- •Stroke within = 6 months prior to day 1;
- •Transient Ischaemic Attack (TIA) within = 6 months prior to day 1;
- •Myocardial infarction (MI) within = 6 months prior to day 1;
- •Unstable angina pectoris (AP);
- •New York Heart Association (NYHA) Grade II or greater Congestive Heart Failure (CHF);
- •Cardiac arrhythmia, except stable atrium fibrillations;
- •15. Left Ventricle Ejection Fraction (LVEF) by MUGA or ECHO < 50%.
- •16. Known hypersensitivity to any of the study drug components or its excipie
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