A Phase III Randomized, Double-Blind Study Of Sunitinib (SU011248, SUTENT) Versus Placebo In Patients With Progressive Advanced/Metastatic Well-Differentiated Pancreatic Islet Cell Tumors
The study was terminated on 11 March 2009 because the independent Data Monitoring Committee
determined that the study had met its primary endpoint in demonstrating improvement in
progression-free survival. The decision to terminate the trial was not based on safety
concerns related to sunitinib administration.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Progression Free Survival (PFS)
Time from randomization to first progression of disease (PD) or death for any reason in the absence of documented PD. PFS was calculated as (first event date minus first randomization date +1) divided by 30.4.
From time of randomization through Day 1 of Week 5, Week 9, and then every 8 weeks thereafter until disease progression or death
No
Pfizer CT.gov Call Center
Study Director
Pfizer
United States: Food and Drug Administration
A6181111
NCT00428597
June 2007
April 2009
Name | Location |
---|---|
Pfizer Investigational Site | Houston, Texas 77030 |
Pfizer Investigational Site | Richmond, Virginia 23249 |
Pfizer Investigational Site | Aurora, Colorado 80012 |
Pfizer Investigational Site | Cedar Rapids, Iowa 52403 |
Pfizer Investigational Site | North Adams, Massachusetts 01247 |
Pfizer Investigational Site | Columbia, Missouri 65201 |