NCT00956436已完成1 期
A Phase 1b, Open-Label Study of Sorafenib With BIIB022 in Subjects With Advanced Hepatocellular Carcinoma
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
- Biogen
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To evaluate the safety and tolerability of BIIB022 given once every 3 weeks in combination with sorafenib in subjects with advanced HCC.
研究概览
简要总结
This is a phase 1b, open-Label study of sorafenib with BIIB022 in subjects with advanced hepatocellular carcinoma.
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
- •Age ≥18 years
- •Histologically-confirmed advanced HCC with at least 1 target lesion measurable by modified RECIST.
- •Child-Pugh score A5 or A
- •ECOG Performance Status of ≤2.
排除标准
- •Known central nervous system or brain metastases.
- •Prior anti-IGF-1R therapy.
- •Prior systemic therapy for advanced HCC. Prior local therapies are only permitted if subjects have documented disease progression according to modified RECIST.
- •Concurrent anticancer therapy.
- •History of myocardial infarction within 12 months prior to Day 1 or chronic heart failure.
- •Acute hepatitis
- •Fibrolamellar HCC
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Sorafenib Monotherapy
Experimental
Sorafenib Monotherapy
干预措施: Sorafenib (Drug)
Sorafenib with BIIB022
Experimental
Sorafenib with BIIB022
干预措施: BIIB022 (Drug)
结局指标
主要结局
To evaluate the safety and tolerability of BIIB022 given once every 3 weeks in combination with sorafenib in subjects with advanced HCC.
时间窗: 6 months
次要结局
- To assess the anti-tumor response in this study population(6 months)
- To evaluate the PK profile of BIIB022 and sorafenib in this study population(6 months)
研究者
研究点 (1)
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