NL-OMON44999已完成2 期
Phase II study with oral fibroblast growth factor-1 inhibitor BIBF1120 as treatment in lung carcinoma patients harboring fibroblast growth factor receptor-1 gene amplification (NVALT-15 study) - NVALT15
Stichting NVALT studies0 个研究点目标入组 40 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
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
- •* Stage IIIB or IV or recurrent NSCLC haboring a positive FISH for FGFR1 amplification.
- •* Age * 18 years.
- •* Measurable disease
- •* ECOG Performance Status of 0 * 1.
- •* Life expectancy > 3 months.
排除标准
- •* Other investigational drugs or treatment in another clinical trial within the past 4 weeks.
- •* Chemo-, hormone-, immunotherapy or therapy with monoclonal antibodies or small tyrosine kinase inhibitors within the past 4 weeks.
- •* Radiotherapy on the target lesions within the last 4 weeks.
- •* Previous therapy with other VEGFR inhibitors or VEGF ligand inhibitors for treatment of NSCLC.
- •* Symptomatic brain metastases or leptomeningeal disease..
- •* Radiographic evidence of cavitation or necrotic tumors.
- •* Centrally located tumors with radiographic evidence of local invasion of major blood vessels.
- •* History of clinically significant haemoptysis within the past 3 months.
- •* Known inherited predisposition to bleeding or thrombosis.
- •* Pre-existing ascites and/or clinically significant pleural effusion.
- •* 21. Patients who are sexually active and unwilling to use a medically acceptable method of contraception..
- •* Pregnancy or lactation. i
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