Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00369252
Status:
COMPLETED
Last Update Posted:
2007-02-28
First Post:
2006-08-25
Brief Title:
Phase I Study of Nimotuzumab in Solid Tumours
Sponsor:
YM BioSciences
Organization:
YM BioSciences
Study Overview
Official Title:
A Phase I Study of TheraCIM-hR3 YMB1000 in Patients With Solid Tumours
Status:
COMPLETED
Status Verified Date:
2007-02
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 I trial of nimotuzumab that will be conducted in patients with advanced incurable solid tumors This is a dose-seeking study to determine the maximum tolerated and recommended phase II doses of nimotuzumab that can be safely given to patients with advanced andor metastatic solid tumors
Detailed Description:
This is an open-label dose-escalating phase I trial of nimotuzumab in patients with advanced incurable solid tumors The objective of this study is to determine the maximum tolerated dose MTD and the recommended phase II dose RP2D of nimotuzumab that can be given in a weekly schedule in patients with advanced andor metastatic solid tumor cancer This study will also examine the safety pharmacodynamics and preliminary efficacy of nimotuzumab in this patient population
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