NL-OMON39893尚未招募2 期
Clinical and pharmacological feasibility study with 2B3-101 in patients with breast cancer and leptomeningeal metastases - N12LMB: Clinical study with 2B3-101 in patients with breast cancer and LM
Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 6 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Age >= 18 years.
- •2. Radiological or cytological evidence of clinically symptomatic leptomeningeal metastases of pathologically confirmed breast cancer.
- •3. Concomitant brain metastases are allowed
- •4. ECOG Performance Status <= 2.
- •5. Estimated life expectancy of at least 8 weeks.
- •6. Stable or decreasing dosage of steroids (e.g.dexamethason) for 7 days prior to baseline MRI 7. Use of non-enzyme inducing anti-epileptic drugs is allowed
- •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. Written informed consent according to local guidelines.
- •10. Local radiation of CNS symptomatic sites more than four weeks prior to start of the study is allowed.
- •11. Previous trastuzumab treatment will be allowed to continue without
- •interruption in patients with histologically-confirmed HER2-positive (IHC 3+ or fluorescence in situ hybridization [FISH] amplified; by
- •clinical assay on either primary or metastatic tumor) adenocarcinoma of the breast
排除标准
- •Candidates will be excluded from study entry if any of the following exclusion criteria exist:
- •Prior Treatment:
- •1. Less than 1 week since the last treatment of lapatinib, dabrafenib, everolimus, capecitabine, anastrazole, letrozole and exemestane; less than 2 weeks since the last treatment of vemurafenib; less than 4 weeks from the last treatment of trametinib, chemotherapy, biological therapy, immunotherapy and systemic radiotherapy (except palliative radiation delivered to <20% of bone marrow); less than 6 weeks for nitrosoureas and mitomycin C Previous trastuzumab treatment will be allowed to continue without interruption in patients with HER2+ breast
- •2. Radiotherapy of the brain or spinal cord/cauda equine or symptomatic bone metastases is allowed before or during 2B3-101 treatment both as single agent and in combination with trastuzumab but radiated localizations will not 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
- •Haematology, coagulation and biochemistry:
- •6. Inadequate bone marrow function, defined as: 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 in absence of 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 ;Other:
- •9. Pregnancy or lactation. A serum pregnancy test needs 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 and 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 treatment with 2B3-101 (day 1);
- •Transient Ischaemic Attack (TIA) within 6 months prior to day 1;
- •Myocardial infarction (MI) within <= 6 months prior to
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