A Phase IIIB, Randomized, Active Controlled Open-Label Study Of Sunitinib (Sutent) 37.5 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
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-Free Survival (PFS)
Time from randomization to the first documentation of tumor progression or death due to any cause in the absence of documented tumor progression, whichever was earlier.
Baseline, Week 5, and every 8 weeks until Year 2
Pfizer CT.gov Call Center
United States: Food and Drug Administration
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