Ignite Creation Date:
2024-05-06 @ 3:26 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04634110
Status:
TERMINATED
Last Update Posted:
2022-10-24
First Post:
2020-10-23
Brief Title:
Brigatinib Before Brain Irradiation Trial B3i Trial
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
Brigatinib Before Brain Irradiation Trial B3i Trial A Phase II Trial of Brigatinib Alone for Brain Metastases From ALK Lung Cancer
Status:
TERMINATED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single arm phase II study of brigatinib alone for patients with brain metastases from anaplastic lymphoma kinase ALK positive non-small cell lung cancer NSCLC who have either not been treated previously with a tyrosine kinase inhibitor TKI targeting ALK or who have had prior exposure to crizotinib
Detailed Description:
In this single-arm phase II trial patients with brain metastases from ALK NSCLC will be treated with brigatinib alone without upfront brain irradiation Patients will have close monitoring with clinical follow up visits and brain magnetic resonance imaging MRI surveillance which will maximize safety and allow for early treatment if disease progression is observed If brigatinib alone can demonstrate high rates of CNS disease control these data could support a strategy of upfront brigatinib alone for carefully selected patients with brain metastases from ALK NSCLC
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA046934 | NIH | None | httpsreporternihgovquickSearchP30CA046934 |