Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00369447
Status:
TERMINATED
Last Update Posted:
2011-07-01
First Post:
2006-08-24
Brief Title:
A Study of Nimotuzumab in Combination With External Radiotherapy in Non-Small Cell Lung Cancer
Sponsor:
YM BioSciences
Organization:
YM BioSciences
Study Overview
Official Title:
A Phase I-II Clinical Study of Nimotuzumab TheraCIM h-R3 in Combination With External Radiotherapy in Stage IIB III and IV NSCLC
Status:
TERMINATED
Status Verified Date:
2011-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was closed due to slow accrual
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 I-II study designed to investigate nimotuzumab TheraCIM h-R3 in combination with external radiation in patients with non-small cell lung cancer The purpose of the Phase I portion of the study is to evaluate the safety and feasibility of the administration of nimotuzumab with palliative radiation in patients who are unsuitable for radical therapy and to select the optimal dose for the Phase II component of the study The primary objective for the Phase II portion of the study is to examine the efficacy of this combination treatment
The Phase I component of this study has been completed The Phase II is now closed to recruitment
The Phase I component of this study has been completed The Phase II is now closed to recruitment
Detailed Description:
This is a randomized double blind multicenter Phase II study with Phase I lead-in Patients enrolled in this study will receive external radiotherapy with or without nimotuzumab TheraCIM h-R3 The objective of the Phase I component of the study is to evaluate the safety and feasibility of the administration of nimotuzumab with palliative radiation in patients who are unsuitable for radical therapy curative intent chemoradiation and to select the optimal biologically effective dose BED for Phase II component of the study In the Phase II component overall survival local and systemic response rates and quality of life will be evaluated inpatients treated with nimotuzumab in combination with palliative radiation vs radiation alone
The Phase I component of this study has been completed The Phase II is now closed to recruitment
The Phase I component of this study has been completed The Phase II is now closed to recruitment
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