Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00452075
Status:
TERMINATED
Last Update Posted:
2014-12-11
First Post:
2007-03-23
Brief Title:
Erlotinib as First-line Treatment of Advanced Non-small Cell Lung Cancer NSCLC for Patients Unfit for Chemotherapy
Sponsor:
Rigshospitalet Denmark
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
A Phase II Study of Erlotinib and Predictive Markers as First-line Treatment of Advanced Non-small Cell Lung Cancer for Patients Unfit for Chemotherapy
Status:
TERMINATED
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A phase II study of Tarceva Erlotinib and predictive markers as first-line treatment of advanced non-small cell lung cancer for patients unfit for chemotherapy NSCLC Clinical Phase II Stage IIIB or IV non-small cell lung cancer NSCLC Primary end point Disease control rate CRPR and SD at 8 weeks patients Secondary end point Safety Serious Adverse Events Adverse Events leading to premature withdrawal unexpected TarcevaTM related AEs Correlation of EGFR expression rate HER1 and FISH potentially predictive for response
An open-label non randomized multicenter clinical trial of TarcevaTM as single agent The sample size is 29 patients in 2 stages and based on Simons optimal 2 stage design Stage 1 will accrue 10 patients if less than 1 response is observed the study will stop if more than 1 response is observed the accrual will continue up till 29 patients A total of 29 patients would be entered and the treatment will be declared to have sufficient activity to deserve further attention if at least 5 patients obtain disease control
An open-label non randomized multicenter clinical trial of TarcevaTM as single agent The sample size is 29 patients in 2 stages and based on Simons optimal 2 stage design Stage 1 will accrue 10 patients if less than 1 response is observed the study will stop if more than 1 response is observed the accrual will continue up till 29 patients A total of 29 patients would be entered and the treatment will be declared to have sufficient activity to deserve further attention if at least 5 patients obtain disease control
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