Ignite Creation Date:
2024-05-06 @ 8:17 AM
Last Modification Date:
2024-10-26 @ 11:58 AM
Study NCT ID:
NCT02706626
Status:
TERMINATED
Last Update Posted:
2023-01-26
First Post:
2016-03-08
Brief Title:
Trial of Brigatinib After Treatment With Next-Generation ALK Inhibitors
Sponsor:
Criterium Inc
Organization:
Criterium Inc
Study Overview
Official Title:
Phase 2 Trial of Brigatinib After Treatment With Next-Generation ALK Inhibitors in Refractory ALK Rearranged Non-Small Cell Lung Cancer NSCLC
Status:
TERMINATED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Did not meet enrollment objectives
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the safety and effectiveness of this investigational drug brigatinib AP261136 in patients with advanced non-small cell lung cancer Non-small cell lung cancer NSCLC who have had first-line treatment for their cancer and it still got worse even after or while taking drugs called ALK inhibitors or anti-cancer drugs that act on tumors Some examples of these anti-cancer drugs are KEYTRUDA or ALECENSA
Detailed Description:
A significant population of Anaplastic Lymphoma Kinase ALK plus Non-small cell lung cancer patients exist that have progressed on or who were intolerant of second generation anaplastic lymphoma kinase inhibitor eg ceritinib or alectinib Brigatinib has demonstrated activity in patients who have progressed on crizotinib but the activity of brigatinib in patients who have progressed on ceritinib alectinib or other second generation anaplastic lymphoma kinase inhibitors is unknown Based on the preclinical data 3 brigatinib has activity against known secondary anaplastic lymphoma kinase mutations suggesting it may retain activity after second-generation anaplastic lymphoma kinase inhibitors
Patients enrolled in ARI-AT-002 must have previously received a second generation Anaplastic lymphoma kinase inhibitor other than brigatinib We have chosen 20 as a clinically meaningful response rate that would justify further study of brigatinib in previously treated anaplastic lymphoma kinase plus disease
Patients enrolled in ARI-AT-002 must have previously received a second generation Anaplastic lymphoma kinase inhibitor other than brigatinib We have chosen 20 as a clinically meaningful response rate that would justify further study of brigatinib in previously treated anaplastic lymphoma kinase plus disease
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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