NCT02254005已完成1 期
An Open Phase I Single Dose Escalation Study of Bivatuzumab Mertansine Administered Intravenously in Female Patients With CD44v6 Positive Metastatic Breast Cancer With Repeated Administration in Patients With Clinical Benefit
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- Maximum tolerated dose (MTD) of bivatuzumab mertansine
研究概览
简要总结
Maximum tolerated dose (MTD), safety, pharmacokinetics, efficacy of bivatuzumab mertansine
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female patients aged 18 years or older
- •patients with breast cancer positive for CD44v6 in at least 50 % of the tumour cells
- •patients with metastases pretreated with anthracyclines and taxanes (unless contraindications to taxanes and / or anthracyclines) or not amenable to established treatments
- •measurable tumour deposits by one or more radiological techniques (MRI, CT)
- •life expectancy of at least 6 months
- •Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2
- •patients must have given written informed consent (which must be consistent with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation)
排除标准
- •hypersensitivity to humanised or murine antibodies, immunoconjugates or the excipients of the trial drugs
- •known secondary malignancy requiring therapy
- •active infectious disease
- •brain metastases requiring therapy
- •neuropathy common toxicity criteria (CTC) grade 2 or above
- •absolute neutrophil count less than 1,500/mm3
- •platelet count less than 100,000/mm3
- •bilirubin greater than 1.5 mg/dl (> 26 μmol/L, système internationale (SI) unit equivalent)
- •aspartate amino transferase (AST) and/or alanine amino transferase (ALT) greater than 3 times the upper limit of normal
- •serum creatinine greater than 1.5 mg/dl (> 132 μmol/L, SI unit equivalent)
- •concomitant non-oncological diseases which are considered relevant for the evaluation of the safety of the trial drug
- •chemo- or immunotherapy within the past four weeks prior to treatment with the trial drug or during the trial (except for present trial drug)
- •radiotherapy to breast and thorax region within the past four weeks before inclusion or during the trial
- •women who are sexually active and unwilling to use a medically acceptable method of contraception
- •pregnancy or lactation
- •treatment with other investigational drugs or participation in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial (except for present trial drug)
- •patients unable to comply with the protocol
研究组 & 干预措施
single dose escalation
Experimental
干预措施: bivatuzumab mertansine (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD) of bivatuzumab mertansine
时间窗: up to day 21
次要结局
- Incidence of adverse events(up to day 21)
- Number of patients with clinically significant findings in laboratory tests(up to day 21)
- Number of patients with clinically significant findings in vital signs(up to day 21)
- Tumor response rate(up to 1 year)
- Concentration of bivatuzumab mertansine(up to day 21)
- Concentration of CD44v6 recognising IgG antibodies (anti-CD44v6-IgG)(up to day 21)
- Number of patients with development of human anti-human antibodies (HAHA)(up to day 21)
研究者
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