Ignite Creation Date:
2024-05-06 @ 8:16 AM
Last Modification Date:
2024-10-26 @ 11:58 AM
Study NCT ID:
NCT02708667
Status:
UNKNOWN
Last Update Posted:
2016-03-15
First Post:
2016-03-05
Brief Title:
An Observational Research Of Crizotinibs Hepatic Toxicity In Non-small Cell Lung Cancer Patients
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
An Observational Research on Relationship Between c-Met Gene Polymorphism Promoter Methylation Level Related Drug Metabolism Enzymes and Crizotinibs Hepatic Toxicity in Non-small Cell Lung Cancer Patients
Status:
UNKNOWN
Status Verified Date:
2016-03
Last Known Status:
RECRUITING
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:
Crizotinib an inhibitor of anaplastic lymphoma kinase ALK was approved by Food and Drug Administration FDA for the treatment of patients with ALK-positive non-small cell lung cancer NSCLC and its administration has achieved considerable success However adverse effects inevitably occurred and the most common one was hepatic toxicity appearing as elevating alanine aminotransferaseALT and aspartate aminotransferaseAST Therefore the investigators try to figure out the mechanism of crizotinib-inducing hepatic toxicity and explore whether there is any biological marker to diagnose this side effect in an early stage which may realize individualized therapy with more efficacy and less side effects
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