Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00165802
Status:
COMPLETED
Last Update Posted:
2013-05-22
First Post:
2005-09-12
Brief Title:
A Phase I Open Label Study of E7974 Administered on a Day 1 of 21-Day Cycle In Patients With Advanced Solid Tumors
Sponsor:
Eisai Inc
Organization:
Eisai Inc
Study Overview
Official Title:
A Phase I Open Label Study of E7974 Administered on Day 1 of a 21-Day Cycle In Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2009-08
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:
The purpose of this study is to determine the maximum tolerated dose MTD of E7974 after bolus IV administration on Day 1 of a 21-day cycle to patients with advanced solid tumors that have progressed following effective therapy or for which no effective therapy exists
Detailed Description:
The MTD for the Day 1 21-Day schedule was defined at the 045 mgm2 dose level The study was terminated prior to full enrollment of the colorectal cancer CRC expansion cohort due to a lack of demonstrated activity resulting in Principal Investigator PI loss interest to continue enrollment Collection of all outstanding data is ongoing and database lock is estimated to be complete in June 2008
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