NL-OMON32472已完成2 期
A PHASE II STUDY OF SORAFENIB IN PATIENTS WITH LOCALLY ADVANCED AND/OR METASTATIC (STAGE IIIB OR IV) NON-SMALL CELL LUNG CANCER (NSCLC) WITH A K-RAS MUTATION - Sorafenib in K-Ras mutated NSCLC
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Histologically advanced NSCLC stage IIIB or IV harbouring a K-RAS mutation
- •2. Disease progression after at least 1 prior chemotherapy regimen that should include a platinum doublet
- •3. Age > 18 years.
- •4. ECOG Performance Status of 0-2
- •5. Subjects with at least one uni-dimensional (for RECIST) measurable lesion. Lesions must be measured by CT-scan.
- •6. Adequate bone marrow, liver and renal function
- •9. Written informed consent
排除标准
- •1. History of cardiac disease: congestive heart failure >NYHA class 2; active CAD (MI more than 6 mo prior to study entry is allowed); cardiac arythmias requiring anti-arythmic therapy( beta blockers or digoxin are permitted) or uncontrolled hypertension.
- •2. History of HIV infection or chronic hepatitis B or C.
- •3. Active clinically serious infections (> grade 2 NCI-CTC version 3.0)
- •4. Symptomatic metastatic brain or meningeal tumors (unless the patient is > 1 months from definitive radiotherapy and off steroids)
研究者
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