NCT00863746已完成3 期
A Phase III, Multi-center, Placebo-Controlled Trial of Sorafenib (BAY43-9006) in Patients With Relapsed or Refractory Advanced Predominantly Non Squamous Non-Small Cell Lung Cancer (NSCLC) After 2 or 3 Previous Treatment Regimens for Advanced Disease
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
- 703
- 主要终点
- Overall Survival
研究概览
简要总结
The purpose of the study is to see if sorafenib plus best supportive care (i.e. in addition to the non-cancer treatments patients would normally receive) is an effective treatment for lung cancer compared to best supportive care alone. The safety and tolerability of the two treatment groups will also be compared. The goal of the study is to test the ability of sorafenib to improve survival compared to best supportive care alone.
详细描述
Acronyms used in Adverse Events section: Disseminated intravascular coagulation (DIC), International normalized ratio (INR), Atrioventricular (AV), Gastrointestinal (GI), Not otherwise specified (NOS), Common Terminology Criteria for Adverse Events (CTCAE), Absolute neutrophil count (ANC), Central nervous system (CNS), Acute respiratory distress syndrome (ARDS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to understand and willingness to sign a written Informed Consent
- •Advanced relapsed or refractory predominantly non squamous NSCLC. The diagnosis must have been confirmed cyto-/ histologically
- •Patients must have measurable or non-measurable disease
- •At least two but not more than three prior standard treatment regimens for NSCLC
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- •Male or female subjects >/= 18 years of age (>/=20 for Japan) at the time of Informed Consent
- •Life expectancy of at least 12 weeks
- •Ability to swallow oral medication
- •Both men and women using adequate barrier birth control measures during the course of the trial and 4 weeks after the completion of trial
- •Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to start of the study drug:
- •Haemoglobin > 9.0 g/dl
- •Absolute neutrophil count (ANC) >1,500/mm3
- •Platelet count >/= 100,000/µl
- •Total bilirubin </=1.5 x the upper limit of normal
- •Alanine aminotransferase (ALT) < 2.5 x upper limit of normal (</= 5 x upper limit of normal in patients with liver metastases) Aspartate aminotransferase (AST) < 2.5 x upper limit of normal (</= 5 x upper limit of normal in patients with liver metastases)
- •Alkaline phosphatase < 4 x upper limit of normal (</= 5 x upper limit of normal in patients with liver metastases)
- •Prothrombin Time (PT)-International Normalized Ratio (INR) or Partial Thromboplastin Time (PTT) < 1.5 x upper limit of normal
- •Serum creatinine < 1.5 x upper limit of normal
- •Calculated creatinine clearance of >/= 50 mL/min
排除标准
- •NSCLC patients with predominantly squamous cell carcinoma histology
- •Excluded medical conditions:
- •History of cardiac disease: Congestive heart failure, Active coronary artery disease (CAD), Cardiac arrhythmias (>Grade 2 NCI-CTCAE [National Cancer Institute-Common Terminology Criteria for Adverse Events] vers. 3.0)
- •Uncontrolled hypertension despite two anti-hypertensive medications
- •History of Human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
- •History of organ allograft
- •Active clinically serious infections (> grade 2 NCI-CTCAE vers. 3.0)
- •Patients with seizure disorder requiring medication
- •Patients with evidence or history of bleeding diathesis or coagulopathy
- •Patients undergoing renal dialysis
- •Pulmonary hemorrhage/ bleeding event >/= CTCAE grade 2 within four weeks prior to the first dose of the study drug
- •Any other hemorrhage/ bleeding event >/= CTCAE grade 3 within four weeks prior to the first dose of the study drug
- •Thrombotic or embolic venous or arterial events such as cerebrovascular accident
- •Pregnant or breast-feeding women.
- •Any condition which could affect the absorption or pharmacokinetics of the study drug
- •Prior treatment with other Vascular Endothelial Growth Factor (VEGF) (R) inhibitors, including compounds that impact vascularity (i.e. sunitinib, thalidomide, vandetanib, vascular disrupting agents [VDA], VEGF-trap and other experimental agents of this class). Only bevacizumab (Avastin) is permitted.
研究组 & 干预措施
Sorafenib (Nexavar, BAY43-9006)
Experimental
Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
干预措施: Sorafenib (Nexavar, BAY43-9006) (Drug)
Placebo
Placebo Comparator
Participants received 2 tablets of placebo orally twice daily (BID)
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 36 months later
Overall survival (OS) was defined as the time from date of randomization to date of death due to any cause. Overall survival of subjects alive at the time of analysis will be censored at their last date of follow-up or database cut off date whichever came first.
次要结局
- Progression-free Survival(From randomization of the first subject until 36 months later assessed every 6 weeks)
- Disease Control(From randomization of the first subject until 36 months later assessed every 6 weeks)
- Objective Tumor Response(From randomization of the first subject until 36 months later assessed every 6 weeks)
- Time to Progression(From randomization of the first subject until 36 months later assessed every 6 weeks)
- Mean Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire for Palliative Care (EORTC QLQ-C15-PAL) - Global Health Status(Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle))
- Mean Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) - Dyspnea(Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle))
- Mean Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) - Coughing Subscale(Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle))
- Mean Change From Baseline in EuroQol-5D (EQ-5D) - Index Score(Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle))
- Mean Change From Baseline in EuroQol-5D (EQ-5D) - VAS Score(Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle))
研究者
相似试验
已完成
3 期
Phase III Trial Comparing Capecitabine in Combination With Sorafenib or Placebo in the Treatment of Locally Advanced or Metastatic HER2-Negative Breast CancerBreast CancerNCT01234337Bayer537
已完成
3 期
Study of Regorafenib as a 3rd-line or Beyond Treatment for Gastrointestinal Stromal Tumors (GIST)Gastrointestinal Stromal TumorsNCT01271712Bayer199
已完成
3 期
Asian Subjects With Metastatic Colorectal Cancer Treated With Regorafenib or Placebo After Failure of Standard TherapyColorectal NeoplasmsNCT01584830Bayer204
已完成
3 期
Sorafenib Tosylate in Treating Patients With Desmoid Tumors or Aggressive FibromatosisDesmoid FibromatosisNCT02066181National Cancer Institute (NCI)87
已完成
3 期
Nexavar-Tarceva Combination Therapy for First Line Treatment of Patients Diagnosed With Hepatocellular CarcinomaCarcinoma, HepatocellularNCT00901901Bayer732