Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00254891
Status:
TERMINATED
Last Update Posted:
2015-03-30
First Post:
2005-11-15
Brief Title:
Trial of PaclitaxelCarboplatin PF-3512676 vs PaclitaxelCarboplatin Alone in Patients With Advanced Non-Small Cell Lung Cancer
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
International Randomized Open-Label Phase 3 Trial of PaclitaxelCarboplatin Plus PF-3512676 Versus PaclitaxelCarboplatin Alone as First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer
Status:
TERMINATED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
See Termination Reason in Detailed Description
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To assess the efficacy and safety of PF-3512676 administered in combination with paclitaxelcarboplatin chemotherapy as first-line treatment in patients with locally advanced or metastatic Non-Small-Cell Lung Cancer NSCLC and to compare it to the efficacy and safety of paclitaxel
Detailed Description:
PF-3512676 dosing was stopped 20 June 2007 in response to DSMC recommendation to close the trial citing lack of efficacy concerns as the primary reason with a safety issue sepsis also contributing to the decision Subjects were allowed to complete standard of care treatmentsurvival follow-up Data collection was completed on 17 July 2008
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