Ignite Creation Date:
2024-05-06 @ 1:58 AM
Last Modification Date:
2024-10-26 @ 11:12 AM
Study NCT ID:
NCT01945021
Status:
COMPLETED
Last Update Posted:
2021-02-21
First Post:
2013-09-05
Brief Title:
Phase II Safety and Efficacy Study of Crizotinib in East Asian Patients With ROS1 Positive ALK Negative Advanced NSCLC
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
Phase II Open Label Single Arm Study of the Efficacy and Safety of Crizotinib in East Asian Patients With Advanced ALK-Negative NSCLC Harboring a Translocation or Inversion Involving the c-ROS Oncogene ROS1 Locus
Status:
COMPLETED
Status Verified Date:
2021-02
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:
To assess treatment effectiveness and safety of oral crizotinib administered to East Asian patients with Advanced Non-Small Cell Lung Cancer NSCLC that is confirmed to be positive for a ROS1 positive gene mutation translocation or inversion and confirmed negative for an ALK mutation
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