Ignite Creation Date:
2024-05-06 @ 3:21 AM
Last Modification Date:
2024-10-26 @ 11:32 AM
Study NCT ID:
NCT02272998
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-09-18
First Post:
2014-10-21
Brief Title:
Ponatinib for Patients Whose Advanced Solid Tumor Cancer Has Activating Mutations Involving the Following Genes FGFR1 FGFR2 FGFR3 FGFR4 RET KIT
Sponsor:
Sameek Roychowdhury
Organization:
Ohio State University Comprehensive Cancer Center
Study Overview
Official Title:
Phase II Study of Ponatinib for Advanced Cancers With Genomic Alterations in Fibroblastic Growth Factor Receptor FGFR and Other Genomic Targets KIT PDGFRá RET FLT3 ABL1
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
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 ponatinib hydrochloride works in treating patients with cancer that has spread to other parts of the body metastatic has failed previous treatment refractory and has one of several alterations or mutations in its deoxyribonucleic acid DNA sequence Ponatinib hydrochloride may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth It is not yet known whether a patients genetic alterations may affect how well ponatinib hydrochloride works
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate the response of ponatinib ponatinib hydrochloride in patients with fibroblast growth factor receptor FGFR altered cancers
SECONDARY OBJECTIVES
I To assess the safety and tolerability of ponatinib in advanced solid tumors with genomic FGFR alterations
II To assess progression free survival PFS and overall survival OS with ponatinib
III To determine candidate genomic and proteomic biomarkers of sensitivity and resistance to ponatinib using unbiased high throughput approaches exome transcriptome reverse phase protein array RPPA
IV To assess response of ponatinib in advanced cancers with subsets of genomic FGFR alterations fusions vs amplifications vs mutations
OUTLINE
Patients receive ponatinib hydrochloride 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 for 52 weeks
I To evaluate the response of ponatinib ponatinib hydrochloride in patients with fibroblast growth factor receptor FGFR altered cancers
SECONDARY OBJECTIVES
I To assess the safety and tolerability of ponatinib in advanced solid tumors with genomic FGFR alterations
II To assess progression free survival PFS and overall survival OS with ponatinib
III To determine candidate genomic and proteomic biomarkers of sensitivity and resistance to ponatinib using unbiased high throughput approaches exome transcriptome reverse phase protein array RPPA
IV To assess response of ponatinib in advanced cancers with subsets of genomic FGFR alterations fusions vs amplifications vs mutations
OUTLINE
Patients receive ponatinib hydrochloride 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 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 |
|---|---|---|---|
| NCI-2014-01499 | REGISTRY | CTRP Clinical Trial Reporting Program | None |