Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00424385
Status:
COMPLETED
Last Update Posted:
2014-07-21
First Post:
2007-01-17
Brief Title:
Study Combining Imatinib Mesylate Gleevec With Sorafenib in Patients With Androgen-independent Prostate Cancer AIPC
Sponsor:
Oncology Specialists SC
Organization:
Oncology Specialists SC
Study Overview
Official Title:
Phase I Study Investigating the Safety and Feasibility of Combining Imatinib Mesylate Gleevec With Sorafenib in Patients With Androgen-Independent Chemotherapy-Failure Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2014-06
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:
Eligible patients will be enrolled in one of 4 cohorts where each cohort will allow 3 patients to be on study Patients will receive both study drugs on escalated dosing schedule until the maximum of 400 mg PO BID is reached for both drugs or toxicity is established Once the pre-specified 400 mg by mouth two times a day PO BID dosing for both drugs is reached without toxicity the study will close for accrual If toxicity is noted prior to reaching the 400 mg PO BID dosing then the dosing schedule that is deemed safest as per study design will be the one used for any future phase II study
Detailed Description:
Gleevec and Sorafenib have modest efficacy in androgen-independent prostate cancer AIPC and the fact that both agents can be given orally with what appears to be tolerable side effects we hypothesize that combining both agents may provide patients with another effective regimen in a disease where therapeutic options are limited This study is designed to investigate the safety of combining Gleevec and Sorafenib as well as feasibility in AIPC patients who have failed one or more lines of systemic chemotherapy Once safety is established a follow-up phase II study will commence to investigate efficacy
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