Ignite Creation Date:
2024-05-06 @ 1:22 PM
Last Modification Date:
2024-10-26 @ 1:13 PM
Study NCT ID:
NCT04005144
Status:
TERMINATED
Last Update Posted:
2022-10-17
First Post:
2019-06-28
Brief Title:
Brigatinib and Binimetinib in Treating Patients With Stage IIIB-IV ALK or ROS1-Rearranged Non-small Cell Lung Cancer
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
A Phase I Study of Brigatinib With Binimetinib in Advanced ALK- or ROS1-Rearranged Non-Small Cell Lung Cancer NSCLC
Status:
TERMINATED
Status Verified Date:
2022-10
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 phase I trial studies the side effects and best dose of brigatinib and binimetinib in treating patients with stage IIIB-IV non-small cell lung cancer and a type of gene mutation called a rearrangement in the ALK or ROS1 genes Brigatinib and binimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
Detailed Description:
PRIMARY OBJECTIVES
I To determine the safety and tolerability of brigatinib in combination with binimetinib in stage IIIB or IV anaplastic lymphoma kinase ALK or ROS1 rearranged non-small cell lung cancer NSCLC and the recommended phase 2 dose
SECONDARY OBJECTIVES
I To determine preliminary efficacy of brigatinib in combination with binimetinib in any line of treatment
II To characterize the pharmacokinetic parameters of brigatinib in combination with binimetinib
EXPLORATORY OBJECTIVES
I To assess circulating tumor deoxyribonucleic acid DNA ctDNA utility in evaluating treatment response
II To evaluate the blockade of downstream signaling indicating response or resistance to treatment of immunohistochemistry IHC for phosphatidylinositol 3-kinase PI3KProtein kinase B AKTMitogen-activated protein kinase MAPK pathway activity evaluation
OUTLINE This a dose-escalation study
Patients receive brigatinib orally PO once daily QD and binimetinib PO twice daily BID on days 1-28 Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up for 30 days and then every 6 months for 12 months
I To determine the safety and tolerability of brigatinib in combination with binimetinib in stage IIIB or IV anaplastic lymphoma kinase ALK or ROS1 rearranged non-small cell lung cancer NSCLC and the recommended phase 2 dose
SECONDARY OBJECTIVES
I To determine preliminary efficacy of brigatinib in combination with binimetinib in any line of treatment
II To characterize the pharmacokinetic parameters of brigatinib in combination with binimetinib
EXPLORATORY OBJECTIVES
I To assess circulating tumor deoxyribonucleic acid DNA ctDNA utility in evaluating treatment response
II To evaluate the blockade of downstream signaling indicating response or resistance to treatment of immunohistochemistry IHC for phosphatidylinositol 3-kinase PI3KProtein kinase B AKTMitogen-activated protein kinase MAPK pathway activity evaluation
OUTLINE This a dose-escalation study
Patients receive brigatinib orally PO once daily QD and binimetinib PO twice daily BID on days 1-28 Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up for 30 days and then every 6 months for 12 months
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2019-02315 | REGISTRY | CTRP Clinical Trial Reporting Program | None |