NCT00075218

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

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Of SU011248 In The Treatment Of Patients With Imatinib Mesylate (Gleevec Tm, Glivec)-Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 361 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A study to assess the safety and efficacy of SU11248 in patients with gastrointestinal stromal tumor (GIST) whose disease has failed imatinib therapy or who were intolerant to imatinib treatment.

Conditions

• Gastrointestinal Stromal Tumor

Interventions

Type	Name	Description
DRUG	Placebo	50 mg taken orally once a day. 6 week treatment cycle (Schedule 4/2) 4 weeks on study drug/2 weeks off study drug.
DRUG	SU011248	50 mg taken orally once a day. 6 week treatment cycle (Schedule 4/2) 4 weeks on study drug/2 weeks off study drug.

Timeline

• Start date: 2003-12-01
• Primary completion: 2008-05-01
• Completion: 2008-05-01
• First posted: 2004-01-08
• Last updated: 2009-09-28
• Results posted: 2009-09-28

Locations

61 sites across 11 countries: United States, Australia, Belgium, Canada, France, Italy, Netherlands, Singapore, Spain, Switzerland, United Kingdom