NCT00492752已完成3 期
A Randomized, Double-blinded, Placebo-controlled Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 226
- 主要终点
- Overall Survival
研究概览
简要总结
The purpose of the study is
- Find out if patients receiving Sorafenib will live longer
- Find out if Sorafenib has any effect on patient reported outcomes
- Find out if Sorafenib prevents the growth or shrinks liver tumors and / or their metastases
- Determine the pharmacokinetics (PK) in patients with liver cancer
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Ages eligible for study: 18 years and above, Genders eligible for study: both
- •Patients who have a life expectancy of at least 12 weeks
- •Patients with advanced Hepatocellular carcinoma (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
- •Accurately measured in at least one dimension according to Response Evaluation Criteria in Solid Tumors (RECIST)
- •Not been previously treated with local therapy
- •Patients who have received local therapy, such as surgery, radiation therapy, hepatic arterial embolization, chemoembolization, radiofrequency ablation, percutaneous ethanol injection or cryoablation are eligible. Previously treated lesions will not be selected as target lesions. Local therapy must be completed at least 4 weeks prior to the baseline scan
- •Patients who have an Eastern Co-operative 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, superficial bladder tumors (Ta [Noninvasive papillary carcinoma], Tis [Carcinoma in situ: "flat tumor"]&T1 [Tumor invades subepithelial connective tissue]). Any cancer curatively treated > 3 years prior to entry is permitted
- •History of cardiac disease
- •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 (Nexavar, BAY43-9006)
Experimental
Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
干预措施: Sorafenib (Nexavar, BAY43-9006) (Drug)
Placebo
Placebo Comparator
Placebo tablets matching in appearance were orally administered bid (twice daily).
干预措施: Placebo (Drug)
结局指标
主要结局
Overall Survival
时间窗: From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization
Overall Survival (OS) was defined as the time from date of randomization to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.
次要结局
- Disease Control(From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization)
- Duration of Response(From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization)
- Number of Participants With Different Tumor Response(From randomization/start of treatment of the first subject until approximately 23 months after randomization when the subjects on placebo were offered the option to crossover to sorafenib treatment)
- Time to Response(From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization)
- Time to Progression (TTP)(From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization)
- Change in Functional Assessment of Cancer Therapy (FACT) Hepatobiliary Symptom Index-8 (FHSI-8) Score From Baseline to Cycle 1 and Cycle 3(Baseline up to Cycle 1 and Cycle 3. From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization)
- Area Under the Curve From Time 0 to 12 Hours Post-dose (AUC 0-12) After 21 Days of Sorafenib Treatment(PK assessments made at following times: pre-dose, 1 h, 2h, 4h, 8h,and 12h after at least 21 consecutive doses during Cycle 1)
- Time to Symptomatic Progression (TTSP)(From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization)
- Change in Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) Score From Baseline to Cycle 3 and End of Treatment(Baseline up to Cycle 3 and end of treatment. From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization)
- Normalized Maximum Concentration (Cmaxnorm) After 21 Days of Sorafenib Treatment(PK assessments made at following times: pre-dose, 1 h, 2h, 4h, 8h,and 12h after at least 21 consecutive doses during Cycle 1)
- Time of Maximum Concentration (Tmax) After 21 Days of Sorafenib Treatment(PK assessments made at following times: pre-dose, 1 h, 2h, 4h, 8h,and 12h after at least 21 consecutive doses during Cycle 1)
- Normalized Area Under the Curve (AUC Norm) After 21 Days of Sorafenib Treatment(PK assessments made at following times: pre-dose, 1 h, 2h, 4h, 8h,and 12h after at least 21 consecutive doses during Cycle 1)
- Maximum Concentration (Cmax) After 21 Days of Sorafenib Treatment(PK assessments made at following times: pre-dose, 1 h, 2h, 4h, 8h,and 12h after at least 21 consecutive doses during Cycle 1)
研究者
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