Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00121732
Status:
COMPLETED
Last Update Posted:
2015-07-01
First Post:
2005-07-15
Brief Title:
An Open-Label Study of E7974 Administered on Days 1 8 and 15 of a 28-Day Cycle and Days 1 and 8 of a 21-Day Cycle in Patients With Solid Malignancies
Sponsor:
Eisai Inc
Organization:
Eisai Inc
Study Overview
Official Title:
A Phase 1 Two-Arm Open-Label Study of E7974 Administered on Days 1 8 and 15 of a 28-Day Cycle and Days 1 and 8 of a 21-Day Cycle in Patients With Solid Malignancies
Status:
COMPLETED
Status Verified Date:
2015-06
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 administered as an intravenous bolus dose on Days 1 8 and 15 of a 28-day cycle Arm A or on Days 1 and 8 of a 21-day cycle Arm B to patients with solid tumors that have progressed following effective therapy or for which no effective therapy exists
Detailed Description:
This is a two-arm open-label non-randomized dose-escalation study to determine the MTD of E7974 administered as an intravenous bolus dose on Days 1 8 and 15 of a 28-day cycle Arm A or on Days 1 and 8 of a 21-day cycle Arm B to patients with solid tumors that have progressed following effective therapy or for which no effective therapy exists Response and progression will be evaluated in this study using Response Evaluation Criteria In Solid Tumors RECIST criteria
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