ACTRN12606000316505终止3 期
A Randomized Controlled Trial Comparing Safety and Efficacy of Carboplatin and Paclitaxel plus or minus Sorafenib (BAY 43-9006) in chemonaive patients with Stage IIIB-IV Non-Small Cell Lung Cancer (NSCLC)
Bayer Australia Limited0 个研究点目标入组 926 人开始时间: 2006年7月24日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 926
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 ot stated（—）
- 性别
- All
入选标准
- •Stage IIIB (with cytologically confirmed malignant pleural or pericardial effusion) or Stage IV histological or cytological confirmation of NSCLC.No prior chemotherapy.Prior local radiotherapy is allowed if it is completed at least 3 weeks prior to the first dose of study drug.Prior surgery is allowed if it is performed at least 4 weeks prior to the first dose of study drug. Performance status (Eastern Cooperative Group) of 0 or 1. Life expectancy of at least 12 weeks.Adequate bone marrow, liver and renal function.Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation. Men should use adequate birth control for at least three months after the last administration of sorafenib. Ability to understand and the willingness to sign a written informed consent. A signed informed consent must be obtained prior to any study specific procedures.
排除标准
- •Any prior systemic anticancer therapy including cytotoxic therapy, targeted agents, experimental therapy, adjuvant, or neo-adjuvant therapy for NSCLC.Cardiac disease: Congestive heart failure > class II New York Heart Association. Patients must not have unstable angina (anginal symptoms at rest) or new-onset angina (began within the last 3 months) or myocardial infarction within the past 6 months Known brain metastasis. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy. Uncontrolled hypertension. Known human immunodeficiency virus (HIV) infection or chronic hepatitis B or C. Active clinically serious infections. Thrombotic or embolic events such as cerebrovascular accident including transient ischemic attacks within the past 6 months. Pulmonary hemorrhage/bleeding event within 4 weeks of first dose of study drug. Any other hemorrhage/bleeding event within 4 weeks of first dose of study drug.Serious, non-healing wound, ulcer, or bone fracture.Evidence or history of bleeding diathesis or coagulopathy.Major surgery, open biopsy or significant traumatic injury within 4 weeks of first dose of study drug.Therapeutic anticoagulation with vitamin K antagonists.Use of St John’s Wort or rifampin (rifampicin).Known or suspected allergy to sorafenib or any agent given in the course of this trial. Previous cancer that is distinct in primary site or histology from NSCLC, EXCEPT cervical cancer in-situ, treated basal cell carcinoma, superficial bladder tumors or any cancer curatively treated less than 3 years prior to study entry.Concurrent cancer that is distinct in primary site or histology from NSCLC.Substance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results.Any condition that impairs patient’s ability to swallow whole pills. Any malabsorption condition.
研究者
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