EUCTR2006-001031-22-GB进行中(未招募)1 期
The Potentiation of Efficacy of Radiotherapy in Non-Small-Cell Lung Cancer (NSCLC) by Inhibition of Akt Activation - Lung Radiotherapy and Nelfinavir
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 入组人数
- 64
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Histologically verified NSCLC including squamous cell carcinoma, adenocarcinoma, and large cell anaplastic carcinoma
- •- Patients with stage II or III NSCLC unsuitable for radical treatment to the primary tumour, where high dose palliative radiotherapy is considered appropriate (CT scan to have been performed within 28 days prior to trial entry)
- •- Performance status WHO 0 - 2
- •- clinically or radiographically measurable disease
- •- absolute neutrophil count >=1500/mm3
- •- Platelets =100 x 109/L (=100000/mm3)
- •- Serum creatinine =1.5 times upper limit of normal
- •- Bilirubin =1.5 times upper limit of normal
- •- Serum AST = 1.5 x upper limit of normal
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Patients with metastatic disease
- •- Patients diagnosed with heart disease or diabetes mellitus
- •- Previous radiotherapy to the chest
- •- Chemotherapy within 4 weeks of the start of experimental treatment
- •- The presence of another malignancy, where the extent of disease or treatment for that condition may interfere with the study endpoints
- •- Patients already taking a Protease Inhibitor
- •- Patients taking drugs contraindicated with NFV, unless stopped 2 weeks or more before start of study:
- •Antiarrhythmics amiodarone, quinidine
- •Antimycobacterials rifampicin
- •Ergot derivatives Dihydroergotamine, ergonovine, ergotamine, methylergonovine
- •Herbal products St. John’s Wort
- •HMG-CoA Reductase Inhibitorssimvastatin, atorvastatin
- •Neuroleptics pimozide
- •Sedatives/hypnotics midazolam,
- •Others Viagra, terfenadine
研究者
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