NCT00712855已完成1 期
A Phase 1B, Multi-center, Open Label, Dose Escalation Study of Mapatumumab ([HGS1012], a Fully-human Monoclonal Antibody to TRAIL-R1) in Combination With Sorafenib as a First Line Therapy in Subjects With Advanced Hepatocellular Carcinoma
Human Genome Sciences Inc., a GSK Company6 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2008年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 6
- 主要终点
- Type, frequency, and severity of adverse events.
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of escalating doses of mapatumumab in combination with sorafenib in subjects with advanced Hepatocellular Carcinoma who are positive for hepatitis B surface antigen or hepatitis C antibody.
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
- •Moderate liver disease
- •Test positive for hepatitis B surface antigen or hepatitis C antibody
- •Locally advanced unresectable/untransplantable or metastatic hepatocellular carcinoma
- •Age 18 years or older
排除标准
- •Received investigational (not yet approved by a regulatory authority) or non-investigational agent to treat hepatocellular carcinoma.
- •Received radiation therapy within 4 weeks before randomization
- •Major surgery within 4 weeks before randomization
- •Minor surgery within 2 weeks before randomization
- •Systemic steroids within 1 week before randomization
- •Hepatic encephalopathy, per the investigator's evaluation
- •History of clinically significant gastrointestinal bleeding requiring procedural intervention within 4 weeks before enrollment
- •History of any infection requiring hospitalization or antibiotics within 2 weeks before randomization
- •Known brain or spinal cord metastases
- •History of other cancers within 5 years before enrollment
- •Pregnant or breast-feeding women
- •Known HIV infection
研究组 & 干预措施
A
Experimental
mapatumumab and sorafenib
干预措施: mapatumumab (Biological)
A
Experimental
mapatumumab and sorafenib
干预措施: sorafenib (Drug)
结局指标
主要结局
Type, frequency, and severity of adverse events.
时间窗: Until disease progression or unacceptable toxicity develops
次要结局
未报告次要终点
研究者
研究点 (6)
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