NCT02209727终止1 期
A Phase I Single Dose Escalation Study of 131I-Sibrotuzumab in Patients With Advanced or Metastatic Non-small Cell Lung Cancer
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
- 9
- 主要终点
- Determination of the dose limiting toxicity (DLT)
研究概览
简要总结
Study to determine the maximum tolerated dose (MTD) and safety profile of a single-dose administration of sibrotuzumab (50 mg) conjugated to an increasing dose of 131 I isotope.
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
- •Evidence of advanced, non-resectable, and/or metastatic non-small cell lung cancer and at least one previous conventional treatment for advanced disease
- •Eastern cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Measurable or evaluable disease, determined by World Health Organization (WHO) criteria using standard imaging modalities, including ultrasound, X-ray, CT and/or Magnetic Resonance Imaging (MRI). Bone scans and/or antibody scans are not to be used to determine the extent of the disease
- •Expected survival of ≥ 16 weeks
- •At least 18 years of age
- •Platelet count ≥ 100 x 10**9/L
- •Absolute neutrophil count ≥ 2.0 x 10**9/L
- •Aspartate aminotransferase (AST) ≤ 3 x upper limit of normal or < 5 x upper limit of normal if liver metastases are present
- •Total bilirubin ≤ 2mg/dL
- •Serum creatinine ≤ 2mg/dL
- •Ability to provide written informed consent
排除标准
- •Known brain metastases
- •Exposure to an investigational agent within 30 days prior to receiving the scout dose
- •Incomplete recovery from surgery or incomplete healing of an incision site or evidence of infection
- •Treatment with cytotoxic chemotherapy, radiation or immunosuppressive therapy within the 30 days (42 days for nitrosoureas and/or mitomycin C) of the scout infusion. Patients using inhaled corticosteroids are considered eligible for enrollment
- •Serious illnesses, i.e., active infections requiring antibiotics, bleeding disorders or other serious illnesses precluding the use of either 131I or sibrotuzumab
- •Women who are breast-feeding or pregnant
- •Men and women who were sexually active and are unwilling to utilize a medically acceptable method of contraception
- •Hypertrophic skin disease or autoimmune disease that possibly involves over-expression of fibroblast activation protein (FAP), which can be targeted by the antibody. These diseases include active inflammatory arthritis, cirrhosis, and keloids
- •Unstable angina pectoris. Patients prescribed medication to control their angina pectoris must have been on a fixed dose for at least 1 month prior to screening to be eligible for trial enrollment
- •Myocardial infarction within 3 months prior to screening
- •New York Heart Association (NYHA) Heart failure stage III or IV, or a left ventricular ejection fraction of ≤ 40 %
- •Impaired lung function, measured by a decrease in forced expiratory volume at one second (FEV1) to less than 50 % of the predicted normal value
研究组 & 干预措施
131I-Sibrotuzumab
Experimental
single therapy dose administered over 60 minutes at week 4
干预措施: 131I-Sibrotuzumab (Drug)
结局指标
主要结局
Determination of the dose limiting toxicity (DLT)
时间窗: up to 12 weeks
Occurrence of toxicity
时间窗: up to 12 weeks
graded according to the Common Toxicity Criteria (CTC)
Determination of the maximum tolerated dose (MTD)
时间窗: up to 12 weeks
MTD is defined as the highest dose below which two patients experience DLT
次要结局
- Maximum tumor response using the World Health Organisation (WHO) Disease Response Criteria(8 weeks after therapeutic infusion)
研究者
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