Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00278993
Status:
COMPLETED
Last Update Posted:
2014-07-14
First Post:
2006-01-17
Brief Title:
Evaluating E7389 in Patients With Hormone Refractory Prostate Cancer With Advanced andor Metastatic Disease Stratified by Prior Chemotherapy
Sponsor:
Eisai Inc
Organization:
Eisai Inc
Study Overview
Official Title:
A Phase II Multicenter Open Label Two Stage Design Study Evaluating E7389 in Patients With Hormone Refractory Prostate Cancer With Advanced andor Metastatic Disease Stratified by Prior Chemotherapy
Status:
COMPLETED
Status Verified Date:
2012-04
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 multi-centre phase II open-label two-stage design single-arm study in patients with hormone-refractory prostate cancer HRPC with advanced rising PSA andor metastatic disease and who have had prior anti-androgen therapy The study will further explore the efficacy of E7389 by enrollment of patients into two strata those who have had no prior systemic chemotherapy for their disease except for mitoxantrone and estramustine and those who failed no more than one previous chemotherapeutic regimen with tubulin-binding agents such as docetaxel
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2005-004271-37 | EUDRACT_NUMBER | None | None |