NCT01418729已完成2 期
Phase-II, Multicenter, Randomized, Double-Blind, Parallel-Group Trial to Compare the Efficacy and Safety of Sorafenib Plus Pravastatin Against Sorafenib Plus Placebo in Patients With Advanced Hepatocarcinoma
Hospital Donostia1 个研究点 分布在 1 个国家目标入组 216 人开始时间: 2011年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
The purpose of this study is to evaluate the overall survival (OS) in order to assess the efficacy and safety of pravastatin as adjuvant treatment to 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
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have been diagnosed with advanced hepatocarcinoma (HCC), confirmed histologically or with non-invasive criteria, according to the clinical practice guidelines by the American Association for the Study of Liver Diseases (AASLD) during a maximum period of 15 days prior to the baseline visit.
- •Males and females, over 18 years of age.
- •Patients who have not previously received treatment with sorafenib.
- •Have an ECOG ≤
- •Liver function: Child A and B
- •Life expectancy greater than 12 weeks.
- •Adequate kidney function: serum creatinine concentration less than or equal to 1.5 times the upper limit of normal (ULN).
- •Sign the written informed consent before starting any procedure, including randomization.
排除标准
- •Patients who routinely (more than 3 times a week) take some sort of statin.
- •Patients with hypersensitivity to statins.
- •Pregnant or breastfeeding women.
- •Peripheral neuropathy: grade 2 or higher
- •Patients who have been diagnosed, within the previous 5 years, with another type of tumor, except for non-melanoma skin cancer, or in situ carcinoma of the cervix or the urinary bladder.
- •Patients receiving chemotherapy or radiotherapy for another type of tumor.
- •Patients with heart failure greater than NYHA grade II, hypertension that is uncontrolled with medication, uncontrolled arrhythmias or AMI within the previous six months.
- •A history of perforation or hemorrhage due to a gastroduodenal ulcus within the last month.
- •Greater hemorrhagic diseases.
- •Asthmatic patients uncontrolled with medication.
- •Any other contraindication associated to the use of statins.
- •Physical or psychological inability to participate in the trial.
- •Treatment with another investigational drug or participation in another clinical trial within 6 months prior to inclusion in the study.
研究组 & 干预措施
Sorafenib plus Pravastatin
Active Comparator
The treatment received will be sorafenib 400 mg/12 h + pravastatin 40 mg/24 h.
干预措施: Pravastatin (Drug)
Sorafenib plus Placebo
Placebo Comparator
The treatment received will be sorafenib 400 mg/12 h + placebo/24 h.
干预措施: Pravastatin (Drug)
结局指标
主要结局
Overall survival
时间窗: 18 months
To evaluate the overall survival (OS) in order to assess the efficacy and safety of pravastatin as adjuvant treatment to sorafenib.
次要结局
- Time to progression(18 months)
- time to symptomatic progression (TTSP).(18 months)
研究者
Juan I. Arenas Ruiz-Tapiador
MD. PHD
Hospital Donostia
研究点 (1)
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