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Clinical Trials/EUCTR2007-000903-14-GB
EUCTR2007-000903-14-GB
Active, not recruiting
Not Applicable

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

Imperial College, London0 sites184 target enrollmentJune 26, 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
on-small cell lung cancer
Sponsor
Imperial College, London
Enrollment
184
Status
Active, not recruiting
Last Updated
14 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 26, 2007
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility 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 \<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

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.

Outcomes

Primary Outcomes

Not specified

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