Ignite Creation Date:
2024-05-06 @ 12:24 PM
Last Modification Date:
2024-10-26 @ 12:58 PM
Study NCT ID:
NCT03753685
Status:
UNKNOWN
Last Update Posted:
2018-11-27
First Post:
2018-11-22
Brief Title:
X-396Ensartinib Capsules in ALK-Positive NSCLC Patients With Brain Metastases
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
Efficacy and Safety of X-396Ensartinib in ALK-Positive NSCLC Patients With Brain Metastases A Phase Ⅱ Open-Label Single Arm Multicenter Study
Status:
UNKNOWN
Status Verified Date:
2018-11
Last Known Status:
NOT_YET_RECRUITING
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 efficacy and safety of oral X-396 Ensartinib capsule in Chinese ALK-positive NSCLC patients with brain metastases eligible patients will be enrolled with objective responses being primary outcome measures
Detailed Description:
In this phase Ⅱ open-label single arm multicenter study efficacy and safety of oral X-396 capsule Ensartinib in 37 Chinese ALK-positive NSCLC patients with brain metastases will be assessed Eligible patients will receive 225mg X-396 capsules once daily and objective responses of brain metastasis based on investigator assessment according to Response Assessment in Neuro-Oncology RANO are primary outcome measures
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