Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00452244
Status:
COMPLETED
Last Update Posted:
2017-08-25
First Post:
2007-03-26
Brief Title:
Gefitinib With or Without Simvastatin in Non-Small Cell Lung Cancer NSCLC
Sponsor:
National Cancer Center Korea
Organization:
National Cancer Center Korea
Study Overview
Official Title:
Randomized Phase II Trail Comparing Gefitinib Plus Simvastatin and Gefitinib Alone in Patients With Previously Treated Advanced Non-Small Cell Lung Cancer NSCLC
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The epidermal growth factor receptor EGFR is a key regulator of growth differentiation and survival of epithelial cancers In a small subset of tumors the presence of activating mutations within the ATP binding site confers increased susceptibility to gefitinib a potent tyrosine kinase inhibitor of EGFR Agents that can inhibit EGFR function through different mechanisms may enhance gefitinib activity in patients lacking these mutations Mevalonate metabolites play significant roles in the function of the EGFR therefore mevalonate pathway inhibitors may potentiate EGFR-targeted therapies Targeting HMG-CoA reductase the rate-limiting enzyme of mevalonate pathway using lovastatin induces a potent apoptosis in a variety of tumor types In an in vitro study combining gefitinib and lovastatin treatment showed synergistic cytotoxic activity through enhanced inhibition of AKT activation by EGF in NSCLC and head neck cancer cell lines Therefore the investigators would like to compare the combination effect of gefitinib and simvastatin the specific and protein inhibitor of HMG-CoA reductase with gefitinib alone in previously treated patients with NSCLC
Detailed Description:
Randomization
1 Sex female vs male
2 ECOG PS 01 vs 23
3 Number of prior regimen one vs two
Gefitinib 250 mg per day Simvastatin 40 mg per day PO or Gefitinib 250 mg per day alone
until progression or unacceptable toxicity
1 Sex female vs male
2 ECOG PS 01 vs 23
3 Number of prior regimen one vs two
Gefitinib 250 mg per day Simvastatin 40 mg per day PO or Gefitinib 250 mg per day alone
until progression or unacceptable toxicity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None