Ignite Creation Date:
2024-05-06 @ 3:10 AM
Last Modification Date:
2024-10-26 @ 11:29 AM
Study NCT ID:
NCT02228421
Status:
TERMINATED
Last Update Posted:
2020-03-11
First Post:
2014-08-27
Brief Title:
Study to Evaluate Real-world Pharmacoeconomics of Crizotinib in NSCLC Patients
Sponsor:
PeriPharm
Organization:
PeriPharm
Study Overview
Official Title:
A Phase IV Multicenter Trial to Evaluate Real-world Pharmacoeconomics of Crizotinib and Its Companion Diagnostic Test in Advanced ALK-positive Non-small Cell Lung Cancer NSCLC Patients
Status:
TERMINATED
Status Verified Date:
2016-10
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 is a phase IV multicenter trial to evaluate the pharmacoeconomic PE impact of crizotinib and its companion diagnostic test used in a real-life setting in advanced ALK-positive non-small cell lung cancer NSCLC patients
NSCLC represent 80 of all new cases of lung cancer One molecular subtype of NSCLC is the ALK-positive subtype The anaplastic lymphoma kinase ALK is a transmembrane receptor tyrosine kinase Activation of ALK occurs through the formation of gene fusions and in NSCLC the gene fusion partner for ALK is primarily EML4 The resulting fusion protein is capable of activating the ALK kinase domain leading to cell growth The estimated prevalence for ALK rearrangements in NSCLC is 3-5 and is more commonly found amongst patients with adenocarcinoma histology in never smokers and in those who are known to be wild type for EGFR and KRAS
Crizotinib is a potent inhibitor of ALK and is approved for the treatment of advanced ALK NSCLC patients This is an example of personalized medicine where patients are selected for treatment based upon a molecular assay and are provided a specific therapy crizotinib for their disease The pharmacoeconomic impact of using genetic information in early treatment decisions in NSCLC has not been determined
The study will enable real-life Heath Economics and Outcome Research HEOR
Approximately 90 patients will be recruited Patients will be asked to complete quality-of-life questionnaires at regular intervals in a real-life setting of treatment with crizotinib
NSCLC represent 80 of all new cases of lung cancer One molecular subtype of NSCLC is the ALK-positive subtype The anaplastic lymphoma kinase ALK is a transmembrane receptor tyrosine kinase Activation of ALK occurs through the formation of gene fusions and in NSCLC the gene fusion partner for ALK is primarily EML4 The resulting fusion protein is capable of activating the ALK kinase domain leading to cell growth The estimated prevalence for ALK rearrangements in NSCLC is 3-5 and is more commonly found amongst patients with adenocarcinoma histology in never smokers and in those who are known to be wild type for EGFR and KRAS
Crizotinib is a potent inhibitor of ALK and is approved for the treatment of advanced ALK NSCLC patients This is an example of personalized medicine where patients are selected for treatment based upon a molecular assay and are provided a specific therapy crizotinib for their disease The pharmacoeconomic impact of using genetic information in early treatment decisions in NSCLC has not been determined
The study will enable real-life Heath Economics and Outcome Research HEOR
Approximately 90 patients will be recruited Patients will be asked to complete quality-of-life questionnaires at regular intervals in a real-life setting of treatment with crizotinib
Detailed Description:
None
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