NCT02254018已完成1 期
An Open Phase I Single Dose Escalation Study of Bivatuzumab Mertansine Administered Intravenously in Patients With Advanced Squamous Cell Carcinoma of the Head and Neck With Repeated Administration in Patients With Clinical Benefit
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •male and female patients aged 18 years or older
- •patients with histologically confirmed squamous cell carcinoma of the head and neck
- •patients with local and / or regional recurrent disease or distant metastases who are refractory to 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 of 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
- •neuropathy grade 2 or above (excluding pre-existing neuropathy of cranial nerves due to surgery, radiotherapy or tumour growth)
- •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 three weeks prior to treatment with the trial drug or during the trial
- •radiotherapy to head and neck region within the past four weeks before inclusion or during the trial
- •men and 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 three weeks before start of therapy or concomitantly with this trial
- •patients unable to comply with the protocol
研究组 & 干预措施
bivatuzumab mertansine
Experimental
single dose escalation
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
- Concentration of CD44v6 recognising IgG antibodies (anti-CD44v6-IgG)(up to day 21)
- Tumor response(up to 1 year)
- Number of patients with adverse events(up to day 21)
- Number of patients with clinically significant changes in laboratory parameters(up to day 21)
- Number of patients with clinically significant changes in vital signs(up to day 21)
- Concentration of bivatuzumab mertansine(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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