A Randomized Controlled Study of BAY43-9006 in Combination With Doxorubicin Versus Doxorubicin in Patients With Advanced Hepatocellular Carcinoma.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 96
- 主要终点
- Time to Progression (TTP)
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of doxorubicin plus sorafenib versus doxorubicin plus placebo in patients with advanced hepatocellular carcinoma (HCC).
详细描述
In addition to the key secondary outcome parameters the following parameters will be assessed in an exploratory manner: relative time to progression (TTP), time to symptomatic progression (TTSP), response rate (RR) and overall survival between the 2 study populations.
The possible and potential predictive assays of clinical benefit through an assessment of the correlation between the defined baseline characteristics and key clinical endpoints.
The safety and tolerability will be assessed in the adverse event section. Doxorubicin pharmacokinetics in HCC patients treated with sorafenib versus placebo will be compared and the pharmacokinetic data will be correlated with doxorubicin-related adverse events (i.e., cardiotoxicity).
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
- Double (Participant, Investigator)
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
- •Patients who have a life expectancy of at least 12 weeks
- •Patients with advanced HCC (unresectable, and/or metastatic) which has been histologically or cytologically documented
- •Patients must have at least one tumor lesion that meets both of the following criteria:
- •can be accurately measured in at least one dimension according to Response Evaluation Criteria in Solid Tumors (RECIST)
- •has not been previously treated with local therapy
- •Patients who have received local therapy except chemoembolization, such as surgery, radiation therapy, hepatic arterial embolization, radiofrequency ablation, percutaneous ethanol injection or cryoablation are eligible, provided that they either have a target lesion which has not been subjected to local therapy and/or the target lesion(s) within the field of the local therapy has shown an increase of 25% in the size. Local therapy must be completed at least 4 weeks prior to the baseline scan
- •Patients who have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
排除标准
- •Previous or concurrent cancer that is distinct in primary site or histology from HCC, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, and superficial bladder tumors (Ta, Tis & T1). Any cancer curatively treated > 3 years prior to entry is permitted
- •History of cardiac disease
- •Serious myocardial dysfunction
- •Active, clinically serious infections
- •Known history of Human Immunodeficiency Virus (HIV) infection
- •Known Central Nervous System (CNS) tumors including metastatic brain disease
- •Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry
研究组 & 干预措施
Sorafenib + Doxorubicin
"Sorafenib + Doxorubicin" -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)
干预措施: Sorafenib (Nexavar, BAY43-9006) plus Doxorubicin (Drug)
Placebo + Doxorubicin
"Placebo + Doxorubicin" -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)
干预措施: Doxorubicin/Placebo (Drug)
结局指标
主要结局
Time to Progression (TTP)
时间窗: from date of randomization of the first patient until 3 years later
TTP was defined as the time from randomization to radiological disease progression by independent assessment.
次要结局
- Percentage of Participants in Each Category of Best Tumor Response(achieved during treatment or within 30 days after termination of active therapy)
- Time to Symptomatic Progression (TTSP)(from date of randomization of the first patient until 3 years later)
- Duration of Response(from date of randomization of the first patient until 3 years later)
- Time to Response (TTR)(from date of randomization until 3 years later at end of study)
- Percentage of Participants for Whom Disease Control Was Achieved(from date of randomization to end of treatment plus 30 days)
- Overall Survival(from date of randomization of the first patient until 3 years later)
- Progression Free Survival (PFS)(from date of randomization of the first patient until 3 years later)