NCT01405846终止2 期
Tyrosine Kinase Inhibitors in DyplAsia of Lung Epithelium
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Incidence of high grade dysplasia of the bronchial epithelium in patients at high risk of lung dysplasia
研究概览
简要总结
We are going to use a special type of bronchoscopy test to examine patients who have had previous surgical treatment for lung cancer or head and neck cancer. The aim is to determine a) whether we can identify precancerous changes in their airways b) whether this type of testing is acceptable and c) get an initial idea of whether a new drug called gefitinib has any effect on precancerous areas in the airway.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Diagnosis of any second malignancy within the 5 years from date of enrolment, except basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma of the cervix uteri that has been adequately treated with no evidence of recurrent disease for 12 months
- •Evidence of severe or uncontrolled systemic disease or psychiatric disorder that would interfere with the patient's safety
- •Known severe hypersensitivity to Gefitinib or any of the excipients of the product
- •Past medical history of interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis which required steroid treatment or any evidence of clinically active interstitial lung disease
- •Pre-existing idiopathic pulmonary fibrosis
- •History of allergy to contrast medium
- •Insufficient lung function as determined by either clinical examination or an arterial oxygen tension (PaO2) of < 9.3kpa
- •Inability to swallow oral medications
- •Presence of active inflammatory bowel disease, partial or complete bowel obstruction or chronic diarrhoea or any condition which would interfere with absorption of an oral drug.
- •Past medical history of keratitis
- •Past medical history of Sjogren's syndrome
- •Pregnant or breast-feeding
- •Male and female patients (of childbearing age) not using, or not willing to use, protocol mandated contraception
- •Prior EGFR inhibitor use.
- •Concurrent medication with known potent CYP3A4 inhibitors and inducers and/or dosing within 7 days of date of enrolment (e.g.. ketoconazole, rifampin, phenytoin, carbamazepine, barbiturates or herbal preparations containing St John's wort/Hypericum perforatum etc.) or use of other concomitant medication incompatible with study drug (see SmPC)
- •Current treatment on another therapeutic clinical trial or previous investigational agent in the last 12 weeks (supportive care trials or non-treatment trials are allowed)
- •Previous enrolment or treatment in the present study.
研究组 & 干预措施
Gefitinib
Other
Single arm study
干预措施: Gefitinib (Drug)
结局指标
主要结局
Incidence of high grade dysplasia of the bronchial epithelium in patients at high risk of lung dysplasia
时间窗: during the screening broncoscopy - carried out within the first month post consent
Patients will have white/blue light bronchoscopy with biopsy of identified lesions. The incidence of high grade lung epithelial dysplasia will be recorded.
次要结局
- Acceptability of screening patients as measured by success of trial recruitment(12 months)
- Response of high grade dysplasia to treatment (complete / partial / stable / progression)(6 & 12 months)
- Toxicity and acceptability of treatment (proportion of patients refusing study entry).(2 weeks, 4 weeks, 3 & 6 months)
- Successful biobanking of samples(12 months)
研究者
研究点 (1)
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