Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00452387
Status:
TERMINATED
Last Update Posted:
2011-09-16
First Post:
2007-03-26
Brief Title:
Mitoxantrone Prednisone Plus Sorafenib in Taxane-Refractory Metastatic Hormone Refractory Prostate Cancer HRPC
Sponsor:
Accelerated Community Oncology Research Network
Organization:
Accelerated Community Oncology Research Network
Study Overview
Official Title:
Mitoxantrone Prednisone Plus Sorafenib in Taxane-Refractory Metastatic Hormone Refractory Prostate Cancer HRPC
Status:
TERMINATED
Status Verified Date:
2011-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Early stopping rule
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 research study is to determine if the combination of mitoxantrone prednisone and sorafenib will improve the time to progression of advanced stage metastatic hormone-refractory prostate cancer
Detailed Description:
The primary objective of this study is to test the hypothesis that the combination of Mitoxantrone Prednisone and Sorafenib in taxane-refractory patients with metastatic hormone refractory prostate cancer mHRPC will result in an improvement of the median time to progression TTP Since the median ie 50 of patients TTP for MitoxantronePrednisone is 3 months our hypothesis is that 70 will have not progressed at 3 months with this investigational combination Progression will be assessed by radiologic imaging criteria
The early stopping point is 21 subjects If 10 or fewer subjects with tumor favorable response are observed when 21 subjects are accrued then the null hypothesis is accepted and the trial is terminated If 16 or more subjects with tumor favorable response are observed when 21 subjects are accrued then the alternative hypothesis is accepted and the trial is terminated The probability of early stopping under the null is 051 and under the alternative is 039 If the trial progresses until 42 subjects are evaluated and 24 or more subjects with favorable response are observed then the null hypothesis is rejected This design minimizes the average sample number under the null which is 312
The early stopping point is 21 subjects If 10 or fewer subjects with tumor favorable response are observed when 21 subjects are accrued then the null hypothesis is accepted and the trial is terminated If 16 or more subjects with tumor favorable response are observed when 21 subjects are accrued then the alternative hypothesis is accepted and the trial is terminated The probability of early stopping under the null is 051 and under the alternative is 039 If the trial progresses until 42 subjects are evaluated and 24 or more subjects with favorable response are observed then the null hypothesis is rejected This design minimizes the average sample number under the null which is 312
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