Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00372567
Status:
TERMINATED
Last Update Posted:
2011-03-17
First Post:
2006-09-05
Brief Title:
Safety And Effectiveness Of Daily Dosing With Sunitinib Or Imatinib In Patients With Gastrointestinal Stromal Tumors
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A Phase IIIB Randomized Active Controlled Open-Label Study Of Sunitinib Sutent 375 Mg Daily Vs Imatinib Mesylate 800 Mg Daily In The Treatment Of Patients With Gastrointestinal Stromal Tumors GIST Who Have Had Progressive Disease While On 400 Mg Daily Of Imatinib
Status:
TERMINATED
Status Verified Date:
2011-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
See termination reason in detailed description
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A phase IIIb study of patients with gastrointestinal stromal tumors who have had progressive disease while on 400 mg imatinib Patients will be randomly assigned to either sunitinib 375 mg daily or imatinib 800 mg daily This study will find out the benefits and potential side effects of taking sunitinib or imatinib for approximately one year
Detailed Description:
The study prematurely discontinued on July 27 2009 due to poor recruitment and operational futility as a result of changes in clinical practice There were no safety or efficacy concerns regarding the study in the decision to terminate the trial
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