NCT02254044终止1 期
An Open Phase I Dose Escalation Study of Bivatuzumab Mertansine Administered Intravenously Once Per Week for Three Weeks in Patients With Advanced Squamous Cell Carcinoma of the Head and Neck or Esophagus With Repeated Administration Courses 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
- 终止
- 入组人数
- 7
- 主要终点
- Maximum tolerated dose (MTD)
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients from 18 to 80 years of age (both inclusive)
- •patients with histologically confirmed squamous cell carcinoma of the head and neck or esophagus
- •patients with local and / or regional recurrent disease or distant metastases who are refractory to or not amenable to established treatments
- •evaluable tumour deposits
- •life expectancy of at least 3 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 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-, radio- or immunotherapy within the past four weeks prior to treatment with the trial drug or during the trial (except for present trial drug)
- •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 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
bivatuzumab mertansine
Experimental
dose escalation
干预措施: bivatuzumab mertansine (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD)
时间窗: up to 6 months
次要结局
- Mean residence time (MRT)(up to 14 days after last drug administration)
- Number of patients with clinically significant findings in vital signs(up to 14 days after last drug administration)
- Terminal elimination half-life (t1/2)(up to 14 days after last drug administration)
- Trough concentration at steady state (Cpre,ss)(up to 7 days after drug administration)
- Number of patients with development of Human Anti-Human Antibody (HAHA)(up to 14 days after last drug administration)
- Minimum serum concentration during the dosing interval τ at steady state (Cmin,ss)(up to 7 days after drug administration)
- Linearity index (LI)(up to 14 days after last drug administration)
- Area under the serum concentration time curve from time zero to time point 168 hours (AUC0-168)(up to 168 hours)
- Time to reach maximum serum concentration (tmax)(up to 14 days after last drug administration)
- Volume of distribution at steady state (Vss)(up to 14 days after last drug administration)
- Number of patients with clinically significant findings in laboratory examinations(up to 14 days after last drug administration)
- Area under the serum concentration time curve from time zero to the time of the last quantifiable drug concentration (AUC0-tz)(up to 14 days after last drug administration)
- Area under the serum concentration time curve from time point zero to infinity (AUC0-∞)(up to 14 days after last drug administration)
- Volume of distribution during the terminal elimination phase (Vz)(up to 14 days after last drug administration)
- Incidence of adverse events(up to 14 days after last drug administration)
- Maximum serum concentration (Cmax)(up to 14 days after last drug administration)
- Total body clearance (CL)(up to 14 days after last drug administration)
- Tumor response(up to 14 days after last drug administration)
- Accumulation factor (RA)(up to 14 days after last drug administration)
研究者
相似试验
终止
1 期
Dose Escalation of Bivatuzumab Mertansine in Female Patients With CD44v6 Positive Recurrent or Metastatic Breast CancerBreast NeoplasmsNCT02254031Boehringer Ingelheim8
已完成
1 期
Single Dose Escalation Study of Bivatuzumab Mertansine in Female Patients With CD44v6 Positive Metastatic Breast CancerBreast NeoplasmsNCT02254005Boehringer Ingelheim24
已完成
1 期
Single Dose Escalation Study of Bivatuzumab Mertansine in Patients With Advanced Squamous Cell Carcinoma of the Head and NeckHead and Neck NeoplasmsNCT02254018Boehringer Ingelheim31
终止
1 期
Bevacizumab (Avastin) Into the Tumor Resection Cavity in Subjects With Glioblastoma Multiforme at First RecurrenceGlioblastoma MultiformeNCT01526837Brain & Spine Surgeons of New York1
已完成
1 期
Dose Escalation Study of BI 2536 BS in Patients With Advanced Solid Tumours With Repeated Administration in Patients With Clinical BenefitNeoplasmsNCT02211859Boehringer Ingelheim70