Ignite Creation Date:
2024-05-06 @ 1:50 PM
Last Modification Date:
2024-10-26 @ 1:21 PM
Study NCT ID:
NCT04146571
Status:
AVAILABLE
Last Update Posted:
2022-10-20
First Post:
2019-10-28
Brief Title:
Expanded Access to Ensartinib for Participants With ALK NSCLC
Sponsor:
Xcovery Holdings Inc
Organization:
Xcovery Holdings Inc
Study Overview
Official Title:
Expanded Access Intermediate-Size Patient Population Protocol
Status:
AVAILABLE
Status Verified Date:
2022-10
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 multicenter intermediate-sized expanded access treatment protocol to the existing IND 111695 for ensartinib X-396 The treatment plan is designed to provide ensartinib to participants with anaplastic lymphoma kinase ALK-rearranged non-small cell lung cancer NSCLC
Detailed Description:
Open-label multi-center intermediate-sized expanded access treatment protocol for X396-CLI-101 Phase III First-in-Human Dose-Escalation Study of X-396 in Patients with Advanced Solid Tumors and Expansion Phase in Patients with ALK Non-Small Cell Lung Cancer
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