Ignite Creation Date:
2024-05-06 @ 9:20 AM
Last Modification Date:
2024-10-26 @ 12:13 PM
Study NCT ID:
NCT02959619
Status:
COMPLETED
Last Update Posted:
2023-08-21
First Post:
2016-11-06
Brief Title:
Ensartinib in Non-small Cell Lung Cancer Patients With Positive ALK
Sponsor:
Betta Pharmaceuticals Co Ltd
Organization:
Betta Pharmaceuticals Co Ltd
Study Overview
Official Title:
Phase 1 Dose-escalating Open-label Study of Ensartinib an Oral ALK Inhibitor in Patients With ALK-positive Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2023-07
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 study is aimed to determine the maximum tolerated dose of ensartinib an oral ALK inhibitor in Chinese patients with ALK-positive non-small cell lung cancer
Detailed Description:
The initial purpose of the study is to determine the largest amount of ensartinib that can be safely given to humans An expansion phase will be conducted to assess the preliminary anti-tumor activity in ALK-positive non-small cell lung cancer once the recommended Phase 2 dose has been established
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