Ignite Creation Date:
2024-05-05 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00401778
Status:
COMPLETED
Last Update Posted:
2016-12-21
First Post:
2006-11-17
Brief Title:
Trial of RAD001 in Patients With Operable Non-Small Cell Lung Cancer NSCLC
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Trial of RAD001 in Patients With Operable Non-Small Cell Lung Cancer NSCLC
Status:
COMPLETED
Status Verified Date:
2016-11
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:
This is a Phase 1b pre-operative lung cancer trial wherein patients with operable lung cancer will be treated with RAD001 to evaluate the target effects of this compounds on relevant molecular pathways and on the 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose FDG uptake of the tumor by a positron emission tomography PET scan at baseline and immediately prior to surgery The safety profile of RAD001 will also be evaluated
Detailed Description:
This is a Phase 1b pre-operative lung cancer trial wherein patients with operable lung cancer will be treated with RAD001 for 3-4 weeks to study the effects of the novel agent in relevant molecular pathways The study will also assess the FDG uptake of the tumor at baseline and upon completion of therapy before surgery with a PET scan The safety profile of RAD001 will also be evaluated
New agents and regimens are urgently needed for lung cancer treatment With the development of novel agents and small molecules designed to curtail the aggressive aspects of this disease some progress has been realized However much more effort and insight will be required for further real gains to be made We propose that studying the mammalian target of rapamycin mTOR axis known to be abnormal in non-small cell lung cancer NSCLC and translating that knowledge into therapeutic adjustments can lead to meaningful advances in lung cancer treatment
Approximately 35 patients will participate at Winship Cancer Institute of Emory University in Atlanta Georgia
New agents and regimens are urgently needed for lung cancer treatment With the development of novel agents and small molecules designed to curtail the aggressive aspects of this disease some progress has been realized However much more effort and insight will be required for further real gains to be made We propose that studying the mammalian target of rapamycin mTOR axis known to be abnormal in non-small cell lung cancer NSCLC and translating that knowledge into therapeutic adjustments can lead to meaningful advances in lung cancer treatment
Approximately 35 patients will participate at Winship Cancer Institute of Emory University in Atlanta Georgia
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