Ignite Creation Date:
2024-05-06 @ 12:09 AM
Last Modification Date:
2024-10-26 @ 10:45 AM
Study NCT ID:
NCT01500824
Status:
WITHDRAWN
Last Update Posted:
2013-02-25
First Post:
2011-12-22
Brief Title:
A Clinical Study Testing The Safety And Efficacy Of Crizotinib In East Asian Patients With Anaplastic Lymphoma Kinase ALK Positive Advanced Non-Small Cell Lung Cancer
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
Phase 2 Open-label Single Arm Study Of The Efficacy And Safety Of Crizotinib In East Asian Patients With Advanced Non-Small Cell Lung Cancer NSCLC Harboring A Translocation Or Inversion Involving The Anaplastic Lymphoma Kinase ALK Gene Locus
Status:
WITHDRAWN
Status Verified Date:
2013-02
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 an open-label multi-center Phase 2 efficacy and safety study of crizotinib in East Asian patients with advanced Non-Squamous NSCLC harboring a translocation or inversion event involving the ALK gene locus who have received only one prior chemotherapy regimen for advanced NSCLC and this regimen must have been platinum-based Primary objective of this study is to assess the anti-tumor activity and safety profile of crizotinib Secondary objectives are to evaluate clinical efficacy including median progression-free survival PFS and 1-year PFS rate overall survival OS disease control rate DCR at 6 and 12 weeks time to response TTR and duration of response DR
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