Phase 2 Open-label Multi-Center Study to Evaluate the Efficacy and Safety of AMG 386 and Sorafenib as First Line Therapy for Subjects With Advanced or Inoperable Hepatocellular Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 60
- 主要终点
- Progression free survival (PFS) rate at 4 months
研究概览
简要总结
The purpose of this study is to determine whether AMG 386, in combination with Sorafenib, is effective in the treatment of advanced or inoperable Hepatocellular cancer in subjects who have not received any prior systemic therapy except surgery or locoregional therapy.
Disease status and disease progression will be assessed every 8 weeks. Subjects will remain on treatment until: progressive disease by RECIST criteria; clinical progression; death or loss to follow-up; or withdrawal of informed consent.
详细描述
The primary objective is to evaluate the efficacy of AMG 386 in combination with sorafenib as measured by the progression free survival (PFS) rate at 4 months in subjects with advanced or inoperable hepatocellular carcinoma (HCC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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 confirmed advanced or inoperable HCC
- •Child-Pugh A liver function score
- •Measurable disease with at least one unidimensionally measurable lesion per RECIST 1.0 guidelines with modifications
- •Adequate organ and hematological function
- •Men or women greater than or equal to 18 years old
- •Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
排除标准
- •Subject is eligible for a liver transplant per investigators discretion
- •Any previous systemic chemotherapy for HCC
- •History of arterial or venous thromboembolism within 12 months prior to enrollment
- •History of clinically significant bleeding within 6 months prior to enrollment
- •History of central nervous system metastases
- •Clinically significant cardiovascular disease within 12 months
- •Uncontrolled hypertension
- •Subjects with a history of prior malignancy
研究组 & 干预措施
15mg/ kg cohort
AMG 386 15mg/kg intravenously once weekly and Sorafenib 400mg orally twice daily in an every 4 weeks dosing schedule.
干预措施: AMG 386 (Drug)
15mg/ kg cohort
AMG 386 15mg/kg intravenously once weekly and Sorafenib 400mg orally twice daily in an every 4 weeks dosing schedule.
干预措施: Sorafenib (Drug)
10 mg/kg cohort
AMG 386 10mg/kg intravenously once weekly and Sorafenib 400mg orally twice daily in an every 4 weeks dosing schedule.
干预措施: AMG 386 (Drug)
10 mg/kg cohort
AMG 386 10mg/kg intravenously once weekly and Sorafenib 400mg orally twice daily in an every 4 weeks dosing schedule.
干预措施: Sorafenib (Drug)
结局指标
主要结局
Progression free survival (PFS) rate at 4 months
时间窗: 4 months
次要结局
- Incidence of adverse events and significant laboratory abnormalities(Adverse events at every visit, significant laboratory abnormalities at least every 4 weeks)
- Objective response rate, Disease control rate, Progression free survival, Overall survival, Time to progression(Radiologic imaging every 8 weeks)
- Pharmacokinetic parameters for AMG 386 when used in combination with Sorafenib(Weeks 1, 2, 5, 9, and every 16 weeks thereafter)
- Pharmacokinetic parameter for Sorafenib when used in combination with AMG 386(Weeks 2, 5, 9, and every 16 weeks thereafter)
- Incidence of the occurrence of anti-AMG 386 antibody formation(Weeks 1, 5, 9, and every 16 weeks thereafter)
- Baseline values of and changes from baseline in pharmacodynamic, immunologic, biochemical, transcriptional, pharmacogenetic and angiogenic markers(Weeks 1, 2, 5, and every 16 weeks thereafter)