NCT00559117Unknown1 期
A Phase I, Open-Label, Dose Ranging Study to Assess the Safety and Distribution of Single or Multiple Doses of VB-111 in Patients With Advanced Metastatic Cancer
Vascular Biogenics Ltd. operating as VBL Therapeutics3 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2007年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 48
- 试验地点
- 3
- 主要终点
- Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST)
研究概览
简要总结
Aim of the study is to evaluate the safety and find the maximal tolerated dose of VB-111 in Patients with Advanced Metastatic Cancer
详细描述
Nine Cohorts of dose escalating VB-111 were completed with a total of 56 subjects enrolled.
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
- •Patients ≥18 years of age
- •Histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective. For Cohort 8, malignancy will include only NET or RCC.
- •Karnofsky performance status of ≥70%
- •Patients with an adequate hematological profile
- •Patients with an adequate renal function
- •Males and Females of childbearing potential must utilize a standard contraception method
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Pregnant or breastfeeding patients
- •Patients, who suffered from an acute cardiac event within the last 12 months
- •Patients with active vascular disease, either myocardial or peripheral
- •Patients with proliferative and/or vascular retinopathy
- •Patients with known liver disease (alcoholic, drug/toxin induced, genetic, or autoimmune)
- •Patients with known CNS metastatic disease
- •Patients testing positive to one of the following viruses: HIV, HBV or HCV
- •Patients receiving chemotherapy or radiotherapy within the last 4 weeks before enrolment
- •Patients that have undergone major surgery within the last 4 weeks before enrolment
- •Patients may not have received anti-angiogenic therapy within the previous 8 weeks before enrolment.
- •Patients may not have received any other investigational agent within 4 weeks before enrolment.
- •Patients with an ongoing requirement for an immunosuppressive treatment, including the use of glucocorticoids or cyclosporin, or with a history of chronic use of any such medication within the last 4 weeks before enrolment
- •Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
研究组 & 干预措施
Cohort
Experimental
干预措施: VB-111 (Drug)
结局指标
主要结局
Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST)
时间窗: 2 months
次要结局
未报告次要终点
研究者
研究点 (3)
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