Journal article

Updated results from a phase III trial of sunitinib in GIST patients (pts) for whom imatinib (IM) therapy has failed due to resistance or intolerance

PG Casali, CR Garrett, ME Blackstein, M Shah, J Verweij, G McArthur, I Judson, J Li, CM Baum, GD Demetri

Journal of Clinical Oncology | American Society of Clinical Oncology (ASCO) | Published : 2006


9513 Background: Sunitinib malate (previously known as SU11248) is an oral multitargeted tyrosine kinase inhibitor with both antitumor and antiangiogenic effects due to blockade of KIT, PDGFRs, VEGFRs, FLT3, and RET. Initial results from this phase III trial showed sunitinib was associated with significantly longer TTP than placebo in IM-resistant GIST pts. Methods: This double-blind, placebo-controlled, phase III trial compared sunitinib 50 mg/day (N=207) to placebo (N=105) in IM-resistant or -intolerant GIST pts. Treatment was administered in 6-week cycles (4 weeks on, 2 weeks off treatment). The primary endpoint was TTP. Secondary endpoints included PFS, OS, ORR, and pain and health stat..

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