NCT01069328已完成1 期
Study of BAY43-9006 (Sorafenib) in Combination With Carboplatin, Paclitaxel and Bevacizumab in Previously Untreated Patients With Stage IIIB (With Malignant Pleural Effusions) or Stage IV Non-small Cell Lung Cancer (NSCLC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 33
- 主要终点
- The primary objective of this study is to define the safety profile and maximum tolerated dose (MTD) of BAY43-9006 (sorafenib) administered in combination with, carboplatin, paclitaxel and bevacizumab
研究概览
简要总结
To determine the tolerability, maximum tolerated dose and pharmacokinetics of this drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
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 must have Stage IIIB (with malignant pleural effusions) or Stage IV histological or cytological confirmation of non-small cell carcinoma (excluding squamous)
- •Age >/= 18 years old
- •Patients must have at least 1 evaluable lesion. Lesions must be evaluated by CT scan or MRI
- •ECOG Performance Status of 0 to 1
- •Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to start of first dose:
- •Hemoglobin >/= 9.0 g/dL
- •White blood cell (WBC) count >/= 2,500/mm3
- •Absolute neutrophil count (ANC) >/= 1,500/mm3
- •Platelet count >/= 100,000/mm3
- •Total bilirubin </= 1.5 times the upper limit of normal (ULN)
- •ALT and AST </= 2.5 X ULN (</= 5 X ULN for patients with liver involvement)
- •INR </= 1.5 and aPTT within normal limits
- •Serum creatinine </= ULN or creatinine clearance (CrCl) >/= 45 mL/min (CrCl = Wt (kg) x (140-age)/72 x Cr level, female x 0.85) for patients with creatinine levels above institutional normal
- •Urinalysis (UA) must show less than 1+ protein in urine, or the patient will require a repeat UA. If repeat UA shows 1+ protein or more, a 24 hour urine collection will be required and must show total protein </= 1000 mg/24 hour to be eligible
排除标准
- •Patients with squamous histology
- •Cardiac disease: Congestive heart failure > Class II NYHA; active coronary artery disease (MI more than 6 months prior to study entry is allowed); or serious cardiac ventricular arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
- •Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg despite optimal medical management
- •HIV infection or chronic hepatitis B or C
- •Active clinically serious infections (> Grade 2 NCI-CTC Version 3.0)
- •Evidence or history of CNS disease, including primary brain tumors, seizures disorders, or any brain metastasis
研究组 & 干预措施
Arm 1
Experimental
干预措施: Nexavar (Sorafenib, BAY43-9006) (Drug)
Arm 6
Experimental
干预措施: Nexavar (Sorafenib, BAY43-9006) (Drug)
Arm 6
Experimental
干预措施: Bevacizumab (Drug)
Arm 6
Experimental
干预措施: Paclitaxel (Drug)
Arm 6
Experimental
干预措施: Carboplatin (Drug)
Arm 5
Experimental
干预措施: Carboplatin (Drug)
Arm 1
Experimental
干预措施: Bevacizumab (Drug)
Arm 1
Experimental
干预措施: Paclitaxel (Drug)
Arm 1
Experimental
干预措施: Carboplatin (Drug)
Arm 2
Experimental
干预措施: Nexavar (Sorafenib, BAY43-9006) (Drug)
Arm 2
Experimental
干预措施: Bevacizumab (Drug)
Arm 3
Experimental
干预措施: Bevacizumab (Drug)
Arm 2
Experimental
干预措施: Paclitaxel (Drug)
Arm 2
Experimental
干预措施: Carboplatin (Drug)
Arm 3
Experimental
干预措施: Nexavar (Sorafenib, BAY43-9006) (Drug)
Arm 3
Experimental
干预措施: Paclitaxel (Drug)
Arm 3
Experimental
干预措施: Carboplatin (Drug)
Arm 4
Experimental
干预措施: Nexavar (Sorafenib, BAY43-9006) (Drug)
Arm 5
Experimental
干预措施: Paclitaxel (Drug)
Arm 4
Experimental
干预措施: Bevacizumab (Drug)
Arm 4
Experimental
干预措施: Paclitaxel (Drug)
Arm 4
Experimental
干预措施: Carboplatin (Drug)
Arm 5
Experimental
干预措施: Nexavar (Sorafenib, BAY43-9006) (Drug)
Arm 5
Experimental
干预措施: Bevacizumab (Drug)
结局指标
主要结局
The primary objective of this study is to define the safety profile and maximum tolerated dose (MTD) of BAY43-9006 (sorafenib) administered in combination with, carboplatin, paclitaxel and bevacizumab
时间窗: 2 years
次要结局
- The secondary objectives include evaluation of pharmacokinetics, biomarkers, pharmacodynamics and tumor response of patients treated with BAY43-9006 (sorafenib) in combination with bevacizumab, paclitaxel and carboplatin(2 years)
研究者
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