Ignite Creation Date:
2024-05-06 @ 2:10 PM
Last Modification Date:
2024-10-26 @ 1:26 PM
Study NCT ID:
NCT04233567
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-09-18
First Post:
2020-01-15
Brief Title:
Infigratinib for the Treatment of Advanced or Metastatic Solid Tumors in Patients With FGFR Gene Mutations
Sponsor:
Sameek Roychowdhury
Organization:
Ohio State University Comprehensive Cancer Center
Study Overview
Official Title:
A Phase II Study of Oral Infigratinib in Adult Patients With Advanced or Metastatic Solid Tumors With FGFR1-3 Gene Fusions or Other FGFR Genetic Alterations
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-09
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 II trial studies how well infigratinib works in treating solid tumors that have spread to other places in the body advanced or metastatic in patients with FGFR gene mutations such as FGFR1-3 gene fusions or other FGFR genetic alterations Mutations are any changes in the genetic material DNA of a cell FGFR proteins are involved in cell division cell maturation formation of new blood vessels wound healing and bone growth development and maintenance FGFR mutations can cause the FGFR protein to become over-active in diseases such as cancer Infigratinib may stop the growth of tumor cells by blocking FGFR proteins in these tumors
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate the efficacy of single agent infigratinib in patients with advanced or metastatic solid tumors of any histologic classification with FGFR1-3 gene fusionstranslocations or other FGFR genetic alterations with and without prior therapy with different FGFR inhibitor
II To understand response rate and potential for infigratinib to benefit patients who have FGFR alterations including point mutations insertionsdeletions and amplifications in different solid tumor types
SECONDARY OBJECTIVES
I To further evaluate the efficacy of single agent infigratinib II To characterize the safety and tolerability of single agent infigratinib II To evaluate benefit of infigratinib in patients who have received one prior FGFR inhibitor
EXPLORATORY OBJECTIVES
I To detect biomarkers of resistance to infigratinib treatment through tumor sequencing
II To develop a circulating tumor deoxyribonucleic acid DNA ctDNA or liquid biopsy assay optimized for monitoring response to infigratinib and detecting emerging resistance mutations to infigratinib
OUTLINE
Patients receive infigratinib orally PO once daily QD on days 1-21 Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients who complete study treatment for any reason other than disease progression are followed for 30 days every 8 weeks until disease progression and then every 4 months for 1 year All other patients are followed for 30 days and then every 4 months for 1 year
I To evaluate the efficacy of single agent infigratinib in patients with advanced or metastatic solid tumors of any histologic classification with FGFR1-3 gene fusionstranslocations or other FGFR genetic alterations with and without prior therapy with different FGFR inhibitor
II To understand response rate and potential for infigratinib to benefit patients who have FGFR alterations including point mutations insertionsdeletions and amplifications in different solid tumor types
SECONDARY OBJECTIVES
I To further evaluate the efficacy of single agent infigratinib II To characterize the safety and tolerability of single agent infigratinib II To evaluate benefit of infigratinib in patients who have received one prior FGFR inhibitor
EXPLORATORY OBJECTIVES
I To detect biomarkers of resistance to infigratinib treatment through tumor sequencing
II To develop a circulating tumor deoxyribonucleic acid DNA ctDNA or liquid biopsy assay optimized for monitoring response to infigratinib and detecting emerging resistance mutations to infigratinib
OUTLINE
Patients receive infigratinib orally PO once daily QD on days 1-21 Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients who complete study treatment for any reason other than disease progression are followed for 30 days every 8 weeks until disease progression and then every 4 months for 1 year All other patients are followed for 30 days and then every 4 months for 1 year
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 |
|---|---|---|---|
| NCI-2019-06869 | REGISTRY | CTRP Clinical Trial Reporting Program | None |