NCT00372567

Safety And Effectiveness Of Daily Dosing With Sunitinib Or Imatinib In Patients With Gastrointestinal Stromal Tumors

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A phase IIIb study of patients with gastrointestinal stromal tumors who have had progressive disease while on 400 mg imatinib. Patients will be randomly assigned to either sunitinib 37.5 mg daily or imatinib 800 mg daily. This study will find out the benefits and potential side effects of taking sunitinib or imatinib for approximately one year.

Detailed description

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.

Conditions

• Gastrointestinal Stromal Tumor

Interventions

Type	Name	Description
DRUG	sunitinib malate	37.5 mg daily
DRUG	imatinib mesylate	800mg daily

Timeline

• Start date: 2007-06-01
• Primary completion: 2009-11-01
• Completion: 2009-11-01
• First posted: 2006-09-07
• Last updated: 2011-03-17
• Results posted: 2010-12-31

Locations

25 sites across 7 countries: United States, Germany, Hong Kong, Italy, South Korea, Spain, United Kingdom