Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00373113
Status:
TERMINATED
Last Update Posted:
2012-06-25
First Post:
2006-09-05
Brief Title:
A Clinical Trial Comparing Efficacy And Safety Of Sunitinib And Capecitabine
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
Phase III Randomized Multi Center Study Of Sunitinib Malate SU 011248 Or Capecitabine In Subjects With Advanced Breast Cancer Who Failed Both A Taxane And An Anthracycline Chemotherapy Regimen Or Failed With A Taxane And For Whom Further Anthracycline Therapy Is Not Indicated
Status:
TERMINATED
Status Verified Date:
2012-06
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:
To compare efficacy and safety of Sunitinib and Capecitabine in subjects with advanced breast cancer who failed both a taxane and an anthracycline chemotherapy regimen or failed with a taxane and for whom further anthracycline therapy is not indicated
Detailed Description:
Patient enrollment in this trial was discontinued based on statistical assessment for futility An independent Data Monitoring Committee found that even if the trial had been allowed to continue treatment with single agent sunitinib would be unable to demonstrate a statistically significant improvement in the primary endpoint of progression-free survival compared with single agent capecitabine in the study population Pfizer notified clinical trial investigators involved in the study and regulatory agencies of these findings on 25Mar2009 Patients receiving sunitinib will be allowed to receive capecitabine or enter an extension trial if they are receiving clinical benefit from continued sunitinib therapy There were no safety concerns leading to the decision to terminate the study
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