Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00374140
Status:
COMPLETED
Last Update Posted:
2017-10-19
First Post:
2006-09-06
Brief Title:
Phase II Trial of RAD001 Everolimus in Previously Treated Small Cell Lung Cancer
Sponsor:
Ahmad Tarhini
Organization:
University of Pittsburgh
Study Overview
Official Title:
Phase II Trial of RAD001 Everolimus in Previously Treated Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2017-09
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 II two-stage open-label single-agent study of the experimental drug RAD001 everolimus in patients with previously treated small cell lung cancer RAD001 will be administered orally at a dose of 10 mg daily
Detailed Description:
This is a phase II two-stage open-label single-agent study of the experimental drug RAD001 everolimus in patients with previously treated small cell lung cancer Patients may have received up to 2 prior chemotherapy regimens for small cell lung carcinoma but no prior therapy with an m-TOR inhibitor RAD001 will be administered orally at a dose of 10 mg daily A cycle will be defined as 3 weeks of study drug administration and patients will have tumor measurements every 2 cycles Study participation will continue until disease progression or intolerable toxicities In addition in patients who consent archival tumor tissue paraffin block from original biopsy will be collected for research purposes
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