EUCTR2010-023355-29-GB进行中（未招募）1 期
Tyrosine kinase Inhibitors in DysplAsia of Lung epithelium Study 1 - TIDAL 1 Version 1.0
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 32
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
- •Age 18 years or above Resected NSCLC or Squamous cell Head & Neck cancer treated curatively All treatment, including any adjuvant treatment with radiotherapy and/or chemotherapy completed at least 3 months prior to study entry ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1 Suitable for flexible bronchoscopy Able to give signed informed consent Adequate haematological, kidney and liver function : o Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) =2.5 x upper limit of normal (ULN) o Total serum bilirubin =1.5 x ULN o Absolute neutrophil count (ANC) =1500/µL o Platelets =100,000/µL o Haemoglobin =9.0 g/dL o Serum creatinine =2.0 x ULN In addition, the following inclusion criteria must be met during the screening period in order to confirm eligibility for the study treatment No evidence of malignant disease activity on screening High grade dysplasia on autofluorescence bronchoscopy analysis
- •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
- •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 evidenced by CT scan at baseline 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. 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.
研究者
相似试验
进行中（未招募）
不适用
Dasatinib and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic LeukemiaPhiladelphia Chromosome Positive Acute Lymphoblastic Leukemia (ALL)MedDRA version: 14.1Level: LLTClassification code 10000844Term: Acute lymphoblastic leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: LLTClassification code 10034877Term: Philadelphia chromosome positiveSystem Organ Class: 10022891 - InvestigationsEUCTR2010-022946-25-Outside-EU/EEAChildren's Oncology Group195
招募中
2 期
Tyrosine Kinase Inhibitors in Metastastic Adenoid Cystic CarcinomaCarcinoma, Adenoid CysticNCT04974866Qingdao Central Hospital20
进行中（未招募）
不适用
Factors affecting tyrosine kinase inhibitors response in chronic myeloid leukemia patientsDespite the excellent efficacy obtained for the treatment of CML,a significant proportion of patients develop resistance to tyrosine kinase inhibitors.TCTR20180703001/A100
进行中（未招募）
不适用
Impact des Inhibiteurs de Tyrosine Kinase sur la fertilité masculine. GLIFERTI - GLIFERTIEUCTR2007-004497-11-FRASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
已完成
不适用
Safety and efficacy of tyrosine kinase inhibitors for the treatment of severe and progressive pulmonary hypertensiopulmonary hypertensionJPRN-UMIN000015696Hokkaido University Hospital, Internal medicine I5