Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00414388
Status:
COMPLETED
Last Update Posted:
2014-04-07
First Post:
2006-12-19
Brief Title:
Sorafenib to Overcome Resistance to Systemic Chemotherapy in Androgen-independent Prostate Cancer
Sponsor:
Oncology Specialists SC
Organization:
Oncology Specialists SC
Study Overview
Official Title:
Phase III Study to Evaluate the Ability of Sorafenib in Overcoming Resistance to Systemic Chemotherapy in Androgen-independent Prostate Cancer AIPC
Status:
COMPLETED
Status Verified Date:
2014-02
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 primary objective of this study is to evaluate the safety of combining Sorafenib and chemotherapy mitoxantrone or docetaxel in patients with AIPC
Detailed Description:
Patients who have AIPC and are progressing despite systemic chemotherapy will be offered participation in this study Patients who relapse or progress shortly within 12 weeks after discontinuation of chemotherapy with either docetaxelprednisone or mitoxantroneprednisone will also be offered participation in this trial Enrolled patients will receive sorafenib as per protocol define dose Sorafenib will be administered in combination with the last chemotherapy utilized If there is no disease progression after 6 cycles chemotherapy will be stopped and Sorafenib may continue until disease progression
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