A Phase I Biodistribution Study With 186 Re-labelled Humanised Monoclonal Antibody BIWA 4, in Patients With Adenocarcinoma of the Breast
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 主要终点
- t½ (Terminal half-life of the analyte in plasma)
研究概览
简要总结
The primary objectives of this study were to assess the safety and tolerability of intravenously (i.v.) administered 186Rhenium (186Re)-labelled bivatuzumab and to investigate the biodistribution and pharmacokinetics of 186Re-labelled bivatuzumab in patients with adenocarcinoma of the breast
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have histological or cytological confirmation of a primary adenocarcinoma of the breast
- •Patients destined for tumour extirpation or mastectomy
- •Patients over 18 years of age
- •Patients younger than 80 years of age
- •Patients who had given 'written informed consent'
- •Patients with a life expectancy of at least 3 months
- •Patients with a good performance status: Karnofsky > 60
排除标准
- •Life-threatening infection, allergic diathesis, organ failure (bilirubin > 30µmol/l and/or creatinine > 150 µmol/l) or evidence of a recent myocardial infarction on ECG or unstable angina pectoris
- •Pre-menopausal women (last menstruation <= 1 year prior to study start)
- •Not surgically sterile (hysterectomy, tubal ligation) and
- •Not practicing acceptable means of birth control, (or not planned to be continued throughout the study). Acceptable methods of birth control include oral, implantable or injectable contraceptives
- •Women with a positive serum pregnancy test at baseline
- •White blood cell count < 3000/mm³, granulocyte count < 1500/mm³ or platelet count < 100000/mm³. Details of prior chemotherapy or radiotherapy had to be known
- •Hematological disorders, congestive heart failure, bronchial asthma, alimentary or contact allergy, severe atopy or allergy
研究组 & 干预措施
BIWA 4
Generic Name: Bivatuzumab
186Re-labelled humanised monoclonal antibody BIWA 4
干预措施: BIWA 4 (Drug)
结局指标
主要结局
t½ (Terminal half-life of the analyte in plasma)
时间窗: up to 240 hours after infusion
Number of patients with adverse events
时间窗: up to 6 weeks after infusion
Vss (Apparent volume of distribution under steady state conditions)
时间窗: up to 240 hours after infusion
Number of patients with clinically significant changes in vital signs
时间窗: up to 6 weeks after infusion
Uptake of 186Re-labelled hMAb BIWA 4 in tumour and normal tissue samples
时间窗: after surgery on day 8
Biodistribution assessed from biopsy sample as percentage of the injected dose per kg tissue (%ID/kg)
Presence of Human-Anti-Human-Antibody (HAHA)
时间窗: up to 6 weeks after infusion
Cmax (Maximum measured concentration of the analyte in plasma)
时间窗: up to 240 hours after infusion
MRT (Mean residence time of the analyte in the body)
时间窗: up to 240 hours after infusion
CL (Total body clearance)
时间窗: up to 240 hours after infusion
Vz (Apparent volume of distribution during the terminal phase)
时间窗: up to 240 hours after infusion
Actual uptake of 186Re-labelled hMAb BIWA 4 in tumour and normal tissue samples
时间窗: at 72 hours after infusion
expressed as %ID/kg
Number of patients with abnormal changes in laboratory parameters
时间窗: up to 6 weeks after infusion
AUC0-∞ (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
时间窗: up to 240 hours after infusion
tmax (Time from dosing to the maximum concentration of the analyte in plasma)
时间窗: up to 240 hours after infusion
次要结局
未报告次要终点