An Open-label, Randomized, Multi-center, Phase II Study to Compare the Safety and Efficacy of TKI258 Versus Sorafenib as First-line Treatment in Adult Patients With Advanced Hepatocellular Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- Overall Survival - Overall Survival
研究概览
简要总结
The purpose of this open-label, randomized, phase II study is to compare the safety and efficacy of dovitinib versus sorafenib as first-line treatment in adult patients with advanced Hepatocellular Carcinoma (HCC). This trial will be opened in countries of the Asia-Pacific region.
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
- 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
- •Diagnosis of advanced Hepatocellular Carcinoma (HCC) according to the AASLD Guidelines
- •Advance HCC Stage B and C according to BCLC staging classification
- •Child Pugh A
- •At least one measurable lesion as assessed by CT or MRI
- •ECOG PS of 0 or 1
- •Adequate bone marrow, liver, and renal function
排除标准
- •Prior systemic therapy for HCC
- •Brain metastases
- •Active bleeding (including variceal bleeding as the result of esophageal varices) Patients who have received a liver transplant or are awaiting an immediate transplant
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
TKI258
capsule
干预措施: dovitinib (Drug)
Sorafenib
tablet
干预措施: sorafenib (Drug)
结局指标
主要结局
Overall Survival - Overall Survival
时间窗: Every 6 weeks from date of randomization until the patient has progressed, or the patient can no longer be followed, or at least 130 deaths have been observed in the study, whichever came first.
The overall survival (OS), defined as the time from date of randomization to the date of death from any cause. If a patient was not known to have died at the date of analysis cut-off, OS was censored at the last date of contact. Survival information was collected every 6 wks until at least 130 deaths have been observed
次要结局
- Time to Tumor Progression (Tumor Assessment)(Every 6 weeks from date of randomization until the patient has progressed, or the patient can no longer be followed, or at least 130 deaths have been observed in the study, whichever came first.)
- Time to Definitive Deterioration in ECOG Performance Status (PS)(Every 6 weeks from date of randomization until the patient has progressed, or the patient can no longer be followed, or at least 130 deaths have been observed in the study, whichever came first)
- Pharmacokinetic (PK) Parameter of Tmax Following a Single Dose of TKI258(Week 1 day 1, week 4 day 5)
- Pharmacokinetic (PK) Parameter of AUCtau Following a Single Dose of TKI258(Week 1 day 1, week 4 day 5)
- Disease Control Rate (Tumor Assessment)(Every 6 weeks from date of randomization until the patient has progressed, or the patient can no longer be followed, or at least 130 deaths have been observed in the study, whichever came first.)
- Pharmacokinetic (PK) Parameter of Cmax Following a Single Dose of TKI258(Week 1 day 1, week 4 day 5)