Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00124566
Status:
COMPLETED
Last Update Posted:
2016-01-18
First Post:
2005-07-26
Brief Title:
Study of Irofulven in Patients With Hormone-refractory Prostate Cancer
Sponsor:
Eisai Inc
Organization:
Eisai Inc
Study Overview
Official Title:
Three-Arm Randomized Phase II Clinical Study of IrofulvenPrednisone IrofulvenCapecitabinePrednisone or MitoxantronePrednisone in Docetaxel-Pretreated Hormone-Refractory Prostate Cancer Patients
Status:
COMPLETED
Status Verified Date:
2016-01
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 assess the efficacy and safety of irofulven-based regimens compared to mitoxantrone plus prednisone in patients with hormone-refractory prostate cancer HRPC whose disease has progressed following Taxotere based regimens
Detailed Description:
For every five patients randomized two will receive treatment number 1 irofulven prednisone two patients will receive treatment number 2 irofulven capecitabine Xeloda prednisone and one patient will receive treatment number 3 mitoxantrone prednisone This is not a blinded study so both the patient and doctor will know which treatment has been assigned
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