Ignite Creation Date:
2024-05-06 @ 10:08 AM
Last Modification Date:
2024-10-26 @ 12:25 PM
Study NCT ID:
NCT03178071
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2019-11-04
First Post:
2017-06-02
Brief Title:
Expanded Access For Lorlatinib For Patients With Non Small Cell Lung Cancer ALK Positive or ROS1 Positive
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
AN EXPANDED ACCESS PROTOCOL FOR LORLATINIB FOR TREATMENT OF PATIENTS WITH ADVANCED NON-SMALL CELL LUNG CANCER HARBORING SPECIFIC MOLECULAR ALTERATIONS
Status:
NO_LONGER_AVAILABLE
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This expanded access study has being designed following a demand from the FDA given the increase in the number of request for single patient INDs for lorlatinib
Detailed Description:
Given that an Expanded Access study does not meet the definition of a controlled clinical investigation and as such is not considered an applicable drug clinical trial per NIH Basic Results for such studies are not required to be reported Protocol B7461020 has been identified as an Expanded Access trial and has been registered to ClinicalTrialsgov however Basic Results will not be posted This statement has been placed in the Detailed Description section of the protocol registration on ClinicalTrialsgov
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