Ignite Creation Date:
2024-05-06 @ 1:58 AM
Last Modification Date:
2024-10-26 @ 11:12 AM
Study NCT ID:
NCT01948141
Status:
COMPLETED
Last Update Posted:
2017-06-08
First Post:
2013-09-18
Brief Title:
Nintedanib in Treating Patients With Advanced Non-Small Cell Lung Cancer Who Have Failed Up to Two Previous Chemotherapy Regimens
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
FGFR1 Amplification as A Predictor of Efficacy in A Biomarker-Driven Phase II Study of BIBF 1120 in Advanced Squamous Cell Lung Cancer Patients Who Have Failed Up to Two Prior Chemotherapeutic Regimens
Status:
COMPLETED
Status Verified Date:
2017-05
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 nintedanib works in treating patients with advanced non-small cell lung cancer who have failed up to two previous chemotherapy regimens Nintedanib 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 6-month progression-free survival PFS rate of fibroblast growth factor receptor 1 FGFR1 amplified squamous cell lung cancer patients treated with BIBF 1120 nintedanib
SECONDARY OBJECTIVES
I Compare the 6-month PFS rate for the entire FGFR1 amplified group versus the FGFR1 non-amplified patients
II Compare the 6-month PFS rate for each FGFR1 amplified group low intermediate and high versus historical controls and FGFR1 non-amplified patients
III To assess the following endpoints overall and by FGFR1 group PFS overall survival OS confirmed tumor response rate and adverse events
TERTIARY OBJECTIVES
I The relation of FGFR1 gene copy number with PFS OS confirmed response rate and adverse events
II The relationship fibroblast growth factor receptor FGFR polymorphisms with toxicity and efficacy
OUTLINE
Patients receive nintedanib orally PO twice daily BID 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 8 weeks
I To evaluate the 6-month progression-free survival PFS rate of fibroblast growth factor receptor 1 FGFR1 amplified squamous cell lung cancer patients treated with BIBF 1120 nintedanib
SECONDARY OBJECTIVES
I Compare the 6-month PFS rate for the entire FGFR1 amplified group versus the FGFR1 non-amplified patients
II Compare the 6-month PFS rate for each FGFR1 amplified group low intermediate and high versus historical controls and FGFR1 non-amplified patients
III To assess the following endpoints overall and by FGFR1 group PFS overall survival OS confirmed tumor response rate and adverse events
TERTIARY OBJECTIVES
I The relation of FGFR1 gene copy number with PFS OS confirmed response rate and adverse events
II The relationship fibroblast growth factor receptor FGFR polymorphisms with toxicity and efficacy
OUTLINE
Patients receive nintedanib orally PO twice daily BID 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 8 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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-2013-01618 | REGISTRY | None | None |
| I 225512 | OTHER | None | None |
| P30CA016056 | NIH | Roswell Park Cancer Institute | httpsreporternihgovquickSearchP30CA016056 |