NCT00137449

Study Of SU011248 Administered On A Continuous Daily Dosing Schedule In Patients With Gastrointestinal Stromal Tumor

A Phase 2 Efficacy And Safety Study Of SU011248 Administered In A Continuous Daily Regimen In Patients With Advanced Gastrointestinal Stromal Tumor

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the antitumor activity of SU011248 in advanced, imatinib mesylate-resistant gastrointestinal stromal tumor (GIST) when administered on a continuous daily dosing schedule

Detailed description

Subjects experiencing clinical benefit after 1 year on study were offered continued treatment with SU011248 on a separate protocol.

Conditions

• Gastrointestinal Stromal Tumors

Interventions

Type	Name	Description
DRUG	SU011248	37.5 mg once daily on a continuous daily dosing schedule. Study medication continued as long as patient was obtaining clinical benefit, or until significant toxicity, or withdrawal of consent, for up to 1 year on study.

Timeline

• Start date: 2005-09-01
• Primary completion: 2008-04-01
• Completion: 2008-04-01
• First posted: 2005-08-29
• Last updated: 2009-09-15
• Results posted: 2009-09-04

Locations

4 sites across 3 countries: United States, France, Italy