Ignite Creation Date:
2024-05-06 @ 2:40 AM
Last Modification Date:
2024-10-26 @ 11:22 AM
Study NCT ID:
NCT02109016
Status:
TERMINATED
Last Update Posted:
2019-07-29
First Post:
2014-04-07
Brief Title:
A Study to Assess the Efficacy and Safety of the VEGFR-FGFR Inhibitor Lucitanib Given to Patients With AdvancedMetastatic Lung Cancer and FGF VEGF or PDGF Related Genetic Alterations
Sponsor:
Clovis Oncology Inc
Organization:
Clovis Oncology Inc
Study Overview
Official Title:
A Single Arm Open-label Phase 2 Study to Assess the Efficacy and Safety of Lucitanib Given Orally as a Single Agent to Patients With AdvancedMetastatic Lung Cancer and FGF VEGF or PDGF Related Genetic Alterations
Status:
TERMINATED
Status Verified Date:
2019-07
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:
The purpose of this study is to determine whether lucitanib is safe and effective in the treatment of patients with advancedmetastatic lung cancer and fibroblast growth factor FGF vascular endothelial growth factor receptor VEGF or platelet derived growth factor PDGF related genetic alterations
Detailed Description:
Lucitanib is an oral inhibitor of the tyrosine kinase activity of FGFR 1-3 VEGFR 1-3 and PDGFR αβ Lucitanib has demonstrated potent anti-tumor and anti-angiogenic activity in vitro proliferation assays and in vivo using human tumor xenograft models with a trend for stronger efficacy in those with genomic aberrancies of FGF or PDGF Abnormalities in the FGF VEGF and PDGF-related genes are observed across lung cancer histologies
The first in human trial of lucitanib demonstrated that daily lucitanib is clinically active in patients with advanced solid tumors Specifically patients with FGFR1-amplification appeared to derive particular benefit from lucitanib
Based on these results this study is designed to explore the safety and anti-tumor activity of daily lucitanib in lung cancer patients with FGF VEGF and PDGF genetic alterations
The first in human trial of lucitanib demonstrated that daily lucitanib is clinically active in patients with advanced solid tumors Specifically patients with FGFR1-amplification appeared to derive particular benefit from lucitanib
Based on these results this study is designed to explore the safety and anti-tumor activity of daily lucitanib in lung cancer patients with FGF VEGF and PDGF genetic alterations
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