Status:

TERMINATED

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

Lead Sponsor:

Pfizer

Conditions:

Gastrointestinal Stromal Tumor

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief 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 i...

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 th...

Eligibility Criteria

Inclusion

  • Patients with gastrointestinal stromal tumors whose disease has progressed on imatinib 400 mg daily.

Exclusion

  • Current treatment with any chemotherapy other than imatinib.
  • Current treatment with any dose of imatinib other than 400 mg

Key Trial Info

Start Date :

June 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 1 2009

Estimated Enrollment :

69 Patients enrolled

Trial Details

Trial ID

NCT00372567

Start Date

June 1 2007

End Date

November 1 2009

Last Update

March 17 2011

Active Locations (25)

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Page 1 of 7 (25 locations)

1

Pfizer Investigational Site

Detroit, Michigan, United States, 48201

2

Pfizer Investigational Site

Farmington Hills, Michigan, United States, 48334

3

Pfizer Investigational Site

City of Saint Peters, Missouri, United States, 63376

4

Pfizer Investigational Site

Creve Coeur, Missouri, United States, 63141