NCT01229865已完成2 期
Safety and Efficacy of VB-111 in Subjects With Advanced Differentiated Thyroid Cancer
Vascular Biogenics Ltd. operating as VBL Therapeutics2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2010年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Objective response
研究概览
简要总结
The purpose of this study is to examine the safety and evaluate the response of VB-111 on DTC.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed advanced DTC (papillary, follicular, Hurthle cell);
- •Absence of sensitivity to therapeutic radioiodine;
- •Measurable disease, defined as at least one non-bony lesion that can be accurately measured in at least one dimension as confirmed with spiral CT scan
- •Life expectancy >3 months; ECOG performance status (PS) 0, 1, or 2; Karnofsky performance status of ≥60%;
- •Subjects with a normal/acceptable hematological profile
- •Subjects with adequate renal function
排除标准
- •Presence of any of the following:
- •Radiotherapy or chemotherapy <4 weeks prior to baseline visit; (Concurrent and/or prior therapy with octreotide will be allowed, provided tumor progression on this therapy has been demonstrated; Concurrent and/or prior therapy with biphosphonates will be allowed)
- •Radiotherapy to ≥25% of bone marrow;
- •Major surgery <4 weeks prior to baseline visit;
- •Any other ongoing investigational agents within 4 weeks before dosing;
- •Subjects who suffered from an acute cardiac event within the last 12 months, including myocardial infarction, cardiac arrythmia, admission for unstable angina, cardiac angioplasty, or stenting;
- •QTc prolongation (defined as QTc interval ≥500 msecs) or other significant ECG abnormalities (e.g. frequent ventricular ectopy, evidence of ongoing myocardial ischemia);
- •Subjects with active vascular disease, either myocardial or peripheral;
- •Subjects with proliferative and/or vascular retinopathy;
- •Subjects with known active liver disease (alcoholic, drug/toxin induced, genetic, or autoimmune) other than related to tumor metastases;
- •Subjects with known CNS metastatic disease (Exception: Subjects with treated CNS metastases stable by radiographic examinations >6 months after definitive therapy administered, are eligible);
- •Subjects testing positive to one of the following viruses: HIV, HBV or HCV;
- •Any of the following conditions:
- •Serious or non-healing wound, ulcer, or bone fracture;
- •History of abdominal fistula, gastro-intestinal perforation, active diverticulitis, intra-abdominal abscess or gastro-intestinal tract bleeding within 6 months of dosing;
- •Any history of cerebrovascular accident (CVA) within 6 months of dosing;
- •Current use of therapeutic warfarin (Note: Low molecular weight heparin and prophylactic low-dose warfarin [INR<1.2 X ULN] are permitted);
- •History of bleeding disorder, including subjects with hemophilia, disseminated intravascular coagulation (DIC), or any other abnormality of coagulation potentially predisposing subjects to bleeding;
- •Poorly controlled depression or anxiety disorder, or recent (within the previous 6 months) suicidal ideation;
- •Subjects with an ongoing requirement for 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 dosing;
- •Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
研究组 & 干预措施
VB-111
Experimental
antiangiogenic and vascular disruptive agent
干预措施: VB-111 (Drug)
结局指标
主要结局
Objective response
时间窗: 6 months
Progression Free Survival
时间窗: 6 months
次要结局
未报告次要终点
研究者
研究点 (2)
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