A Study To Assess The Safety And Efficacy Of SU11248 In Patients With Gastrointestinal Stromal Tumors (Gist)

A Study To Assess The Safety And Efficacy Of SU11248 In Patients With Gastrointestinal Stromal Tumors (Gist)

Gastrointestinal Stromal Tumor

Completed

3

Start Date 12/01/2003

Age of Trial (yrs) 21

Gleevec-resistant

KIT/PDGFRA inhibitor

Block KIT

Specifically GIST and only GIST

A6181004

Pfizer

Randomized

Oral

This study is ongoing, but not recruiting any patients.
This is the phase III randomized study (sunitinib versus placebo) that resulted in the approval of Sutent for Gleevec-resistant/Gleevec-intolerant GIST.
Detailed results of the phase III Sutent trial were published in the October 14th print edition of The Lancet; Dr. George Demetri and colleagues presented results from a phase III trial of Sutent in patients with advanced GIST after failure of Gleevec. The study concluded that Sutent is well tolerated and results in significantly greater time to tumor progression, progression-free survival, overall survival and other measures of tumor response compared to placebo. Early results had previously been presented in abstract form and in presentations at several major oncology meetings.

The randomized trial was conducted at 56 sites in the United States, Australia, Europe and Asia (Singapore). The study accrued 312 patients within 12 months between December 2003 and December 2004.

The trial was designed so that patients were randomized in a 2:1 ratio to receive Sutent or placebo. Patients progressing on the placebo were allowed to cross over and receive Sutent.