Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00290953
Status:
COMPLETED
Last Update Posted:
2008-12-23
First Post:
2006-02-10
Brief Title:
Evaluation of the Overall Survival of Meclinertant Versus Placebo After a First Line Chemotherapy With Cisplatin Etoposide
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Double Blind Randomized Phase II-III Maintenance Study of SR48692 Versus Placebo in Patients With Extensive Stage Small Cell Lung Cancer Following a First Line Chemotherapy With Cisplatin Etoposide
Status:
COMPLETED
Status Verified Date:
2008-12
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:
SESAME
Brief Summary:
To demonstrate an increase in overall survival for patients with newly diagnosed extended stage small cell lung cancer when treated with SR48692 versus placebo after an initial response complete or partial response or stable to first line cisplatin plus etoposide
Primary objective comparison of overall survival between patients in the control arm and the meclinertant arm
Secondary objectives comparison of the progression free survival the time to progression the clinical benefit the quality of life the toxicity and safety between patients in the control arm and the meclinertant arm
Primary objective comparison of overall survival between patients in the control arm and the meclinertant arm
Secondary objectives comparison of the progression free survival the time to progression the clinical benefit the quality of life the toxicity and safety between patients in the control arm and the meclinertant arm
Detailed Description:
None
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