Ignite Creation Date:
2024-05-06 @ 8:49 AM
Last Modification Date:
2024-10-26 @ 12:06 PM
Study NCT ID:
NCT02834936
Status:
UNKNOWN
Last Update Posted:
2017-03-29
First Post:
2016-07-13
Brief Title:
A Clinica Study of Pyrotinib in Patients of Advanced Non-Small Cell Lung Cancer With HER2 Mutation
Sponsor:
Jiangsu HengRui Medicine Co Ltd
Organization:
Jiangsu HengRui Medicine Co Ltd
Study Overview
Official Title:
A Phase 2 Clinica Study Efficacy and Safety of Pyrotinib in Patients of Advanced Non-Small Cell Lung Cancer With HER2 Mutation
Status:
UNKNOWN
Status Verified Date:
2017-03
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:
This study is designed to evaluate the efficacy and safety of Pyrotinib in patients of advanced pre-treated Non-small cell lung cancer With HER2 Mutation
To observe objective response rate ORR of pyrotinib in NSCLC With HER2 Mutation To observe Progression free survival PFS To assess the overall survival OS
A secondary aim is to obtain safety information
To explore the relationship between biomarkers and the toxicityefficacy of Pyrotinib
To observe objective response rate ORR of pyrotinib in NSCLC With HER2 Mutation To observe Progression free survival PFS To assess the overall survival OS
A secondary aim is to obtain safety information
To explore the relationship between biomarkers and the toxicityefficacy of Pyrotinib
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