Ignite Creation Date:
2024-05-06 @ 12:52 PM
Last Modification Date:
2024-10-26 @ 1:05 PM
Study NCT ID:
NCT03868423
Status:
WITHDRAWN
Last Update Posted:
2022-02-18
First Post:
2019-02-04
Brief Title:
Brigatinib in Treating Patients With ALK and ROS1 Gene Alterations and Locally Advanced or Metastatic Solid Cancers
Sponsor:
Sameek Roychowdhury
Organization:
Ohio State University Comprehensive Cancer Center
Study Overview
Official Title:
Phase II Study of Brigatinib for Advanced Solid Cancers Harboring Genomic Alterations in ALK Excluding Lung and ROS1 Oncogenes
Status:
WITHDRAWN
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial studies how well brigatinib works in treating patients with ALK and ROS1 gene alterations and solid cancers that have spread to nearby tissue and lymph nodes or other places in the body Brigatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate the overall response rate ORR of brigatinib in patients with advanced solid tumors harboring genomic alterations in ALK excluding lung and ROS1 all solid tumors
SECONDARY OBJECTIVES
I To assess the safety and tolerability of brigatinib in patients with advanced solid tumors harboring genomic alterations in ALK excluding lung and ROS1 all solid tumors
II To assess progression free survival PFS and overall survival OS in patients with advanced ALK or ROS1 mutated solid tumors treated with brigatinib
III To assess sensitivity and durability of response to brigatinib in different solid tumor types
IV To assess the role of intertumoral and intratumoral heterogeneity in the development of resistance to brigatinib
V To identify candidate genomic including circulating tumor deoxyribonucleic acid DNA and proteomic biomarkers of tumor sensitivity and resistance to brigatinib using high-throughput approaches exome transcriptome reverse phase protein array RPPA
TERTIARY OBJECTIVES
I Correlation of brigatinib exposure with efficacy and safety II Correlation of tumor and plasma biomarkers with brigatinib efficacy and safety
OUTLINE
Patients receive brigatinib orally PO once daily QD on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months for 52 weeks
I To evaluate the overall response rate ORR of brigatinib in patients with advanced solid tumors harboring genomic alterations in ALK excluding lung and ROS1 all solid tumors
SECONDARY OBJECTIVES
I To assess the safety and tolerability of brigatinib in patients with advanced solid tumors harboring genomic alterations in ALK excluding lung and ROS1 all solid tumors
II To assess progression free survival PFS and overall survival OS in patients with advanced ALK or ROS1 mutated solid tumors treated with brigatinib
III To assess sensitivity and durability of response to brigatinib in different solid tumor types
IV To assess the role of intertumoral and intratumoral heterogeneity in the development of resistance to brigatinib
V To identify candidate genomic including circulating tumor deoxyribonucleic acid DNA and proteomic biomarkers of tumor sensitivity and resistance to brigatinib using high-throughput approaches exome transcriptome reverse phase protein array RPPA
TERTIARY OBJECTIVES
I Correlation of brigatinib exposure with efficacy and safety II Correlation of tumor and plasma biomarkers with brigatinib efficacy and safety
OUTLINE
Patients receive brigatinib orally PO once daily QD on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months for 52 weeks
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 |
|---|---|---|---|
| P30CA016058 | NIH | CTRP Clinical Trial Reporting Program | httpsreporternihgovquickSearchP30CA016058 |
| NCI-2017-01394 | REGISTRY | None | None |