Non-small cell lung cancer MedDRA version: 9.1 Level: LLT Classification code 10025050 Term: Lung cancer non-small cell stage I MedDRA version: 9.1 Level: LLT Classification code 10025051 Term: Lung cancer non-small cell stage II MedDRA version: 9.1 Level: LLT Classification code 10025052 Term: Lung cancer non-small cell stage III MedDRA version: 9.1 Level: LLT Classification code 10025053 Term: Lung cancer non-small cell stage IIIA
Conditions
Interventions
Trade Name: Lipostat
Product Name: Pravastatin Sodium
Pharmaceutical Form: Tablet
INN or Proposed INN: PRAVASTATIN SODIUM
CAS Number: 81131706
Current Sponsor code: CRO685
Concentration unit: mg milli
Sponsors
Imperial College, London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate and compare changes in tumour cell proliferation measured through tumour Ki-67 expression following treatment with pravastatin or lovastatin.;Secondary Objective: The secondary objective is to evaluate and compare other biological changes in the tumour following pravastatin or lovastatin treatment and then to identify potential surrogate parameters for anti-tumour effects of statins.;Primary end point(s): The primary objective is to evaluate treatment-induced changes in tumour cell proliferation measured through tumour Ki-67 expression. The primary efficacy endpoint of the trial is the percentage of patients with high tumour Ki-67 expression at the end of treatment with pravastatin or lovastatin. Ki67 expression will primarily be compared between the surgical samples of the treatment groups and the control group. | — |
Countries
United Kingdom
Outcome results
None listed