Ignite Creation Date:
2024-05-06 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06225427
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-01-13
Brief Title:
Gilteritinib for the Treatment of ALK NSCLC
Sponsor:
University of Michigan Rogel Cancer Center
Organization:
University of Michigan Rogel Cancer Center
Study Overview
Official Title:
Phase I Study of Gilteritinib for ALK Positive Non-Small Cell Lung Cancer
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase I trial is studying the safety side effects and best dose of gilteritinib in treating patients with stage IV ALK positive non-small cell lung cancer NSCLC who have progressed on other treatments While there are many approved targeted drugs for ALK NSCLC resistance to these drugs frequently occur Giltertinib is a drug that is already FDA approved for the treatment of a specific type of leukemia However studies using ALK positive lung cancer cells demonstrate activity of gilteritinib against these resistant cells Therefore in this clinical trial the investigators plan to study the effect of giltertinib in patients with ALK NSCLC
Detailed Description:
None
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?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UMCC 2023047 | OTHER | University of Michigan Comprehensive Cancer Center | None |
| NCI-2023-10639 | REGISTRY | None | None |