NCT02029157已完成3 期
A Phase III Randomized Double-blind, Placebo-controlled Trial of ARQ 197 in Subjects With c-MET Diagnostic-high Inoperable Hepatocellular Carcinoma (HCC) Treated With One Prior Sorafenib Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 386
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
The present clinical trial is aiming to evaluate efficacy of ARQ 197 in patients with hepatocellular carcinoma (HCC), who were resistant or intolerable to one systemic chemotherapy regimen including sorafenib.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent form
- •≥20 years old
- •Inoperable HCC which is not eligible for locoregional therapy
- •Diagnosed as c-Met high in tumor sample
- •Radiographic progression is confirmed during or after systemic chemotherapy including sorafenib, or those who are intolerance to the chemotherapy.
- •Eastern Cooperative Oncology Group Performance Status (ECOG PS) is 0 or 1
- •Child-Pugh Class A
- •Having measurable target lesions which are defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1,
- •Negative pregnancy test results
- •Adequate organ function
- •Life expectancy of at least 12 weeks
排除标准
- •More than 2 prior systemic chemotherapy.
- •Prior therapy of c-Met inhibitor (including antibody)
- •Any systemic therapy within ≤2 weeks prior to the randomization
- •Locoregional therapy within ≤4 weeks prior to randomization.
- •Major surgery within ≤4 weeks prior to the randomization
- •Concurrent cancer within ≤5 years prior to the randomization
- •History of cardiac diseases
- •Active clinically serious infections defined as ≥ Grade 3 according to Common Toxicity Criteria for Adverse Effects (CTCAE) 4.0
- •Any psychological disorder affecting Informed Consent
- •Diagnosis positive for anti-HIV antibody and/or anti-HTLV-1 antibody
- •Blood or albumin transfusion within ≤14 days prior to the screening test
- •Concurrent interferon therapy against Hepatitis B Virus (HBV)/ Hepatitis C Virus (HCV)
- •Symptomatic brain metastases
- •History of liver transplantation
- •Inability to swallow oral medications
- •Confirmed interstitial lung disease
- •Pleural effusion and/or clinically significant ascites
- •Pregnancy or breast-feeding
- •Without consent to effective single or combined contraceptive methods
研究组 & 干预措施
ARQ 197
Experimental
Daily oral dose
干预措施: ARQ197 (Drug)
Placebo
Placebo Comparator
Daily oral dose
干预措施: Placebo (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: Estimated median of 8-12 weeks in PFS
Progression-free survival will be compared between ARQ 197 group and Placebo group, to prove the efficacy of ARQ 197 in the population.
次要结局
- Overall survival(Estimated median of 24 weeks in overall survival)
研究者
研究点 (1)
Loading locations...
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