Safety And Effectiveness Of Daily Dosing With Sunitinib Or Imatinib In Patients With Gastrointestinal Stromal Tumors (Resistant at 400 mg Imatinib)

Safety And Effectiveness Of Daily Dosing With Sunitinib Or Imatinib In Patients With Gastrointestinal Stromal Tumors (Resistant at 400 mg Imatinib)

Gastrointestinal Stromal Tumor

Terminated

3

Start Date 07/01/2007

Age of Trial (yrs) 16.8

Gleevec-resistant

KIT/PDGFRA inhibitor

Block KIT

Specifically GIST and only GIST

A6181112

Pfizer

Pfizer Oncology Clinical Trial Information Service 1-877-369-9753 PfizerCancerTrials@emergingmed.com 1-800-718-1021

Randomized

Oral

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