Randomized Phase III Trial to evaluate the effect of statins on tumour biology in non-small cell lung cancer. - Neostat

Imperial College, London0 个研究点目标入组 184 人开始时间: 2007年6月26日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•Histological or cytological confirmed NSCLC or sufficiently strong clinical evidence to justify thoracotomy.
•Stage I-IIIA disease that is suitable for surgical resection.
•Surgery planned between 14 and 42 days after registration.
•Serum Creatinine concentration <1.5 times the upper limit of normal. (ULN)
•Aged 18 or over.
•Written informed consent prior to admission to this study.
•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

•Prior chemotherapy or radiotherapy for this disease.
•Patients treated with statins within 1 year prior to randomization.
•Active liver disease or unexplained elevation of AST and/or ALT >2.5xULN.
•Creatinine Kinase >5xULN.
•Concomitant use of: CYPA4 inhibitors such as cyclosporine, itraconazole, ketoconazole, erythroymicin, clarithromycin,HIV protease inhibitors, jefazodone, or larg quantities of grapefruit juice (>250ml/day)
•Lipid-lowering drugs that can cause myopathy such as gemifibrozil, other fibrates, or lipid-lowering doses (>1g/day) of niacin.
•Amiodarone or verapamil.
•Hypersensitivity to lovastatin or pravastatin or any of their excipients.
•Evidence of significant mediacal condition or laboratory finding which, in the opinion of the investigator, makes it undesirable for the patient to participate in the trial.
•Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study.

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