Ignite Creation Date:
2024-05-06 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 12:54 PM
Study NCT ID:
NCT03672643
Status:
TERMINATED
Last Update Posted:
2023-10-19
First Post:
2018-07-19
Brief Title:
Long Term Safety Observation of Crizotinib in Chinese NSCLC Population
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
AN OPEN-LABEL SINGLE-ARM STUDY OF THE LONG-TERM SAFETY OF XALKORI REGISTERED IN PATIENTS FROM CHINA WITH ADVANCED NON-SMALL CELL LUNG CANCER NSCLC HARBORING A TRANSLOCATION OR INVERSION EVENT INVOLVING THE ANAPLASTIC LYMPHOMA KINASE ALK OR ROS1 LOCUS WHO HAVE PREVIOUSLY BEEN TREATED ON A STUDY OF XALKORI REGISTERED
Status:
TERMINATED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The trial is terminated based on business decision not due to safety concerns or regulatory requirements
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is to allow access to crizotinib who were treated in previous Pfizer-sponsored studies in China
Detailed Description:
This study is a phase 4 study to continually access Xalkori to Chinese patients who were recruited in previous studies of Crizotinib in China and only collect the safety data
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None