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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Gastrointestinal Stromal Tumor

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Trial Information

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


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.


Inclusion Criteria:



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

Exclusion Criteria:

- Current treatment with any chemotherapy other than imatinib.

- Current treatment with any dose of imatinib other than 400 mg

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-Free Survival (PFS)

Outcome Description:

Time from randomization to the first documentation of tumor progression or death due to any cause in the absence of documented tumor progression, whichever was earlier.

Outcome Time Frame:

Baseline, Week 5, and every 8 weeks until Year 2

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A6181112

NCT ID:

NCT00372567

Start Date:

June 2007

Completion Date:

November 2009

Related Keywords:

  • Gastrointestinal Stromal Tumor
  • Gastrointestinal Stromal Tumors

Name

Location

Pfizer Investigational SiteDetroit, Michigan  48201
Pfizer Investigational SiteColumbia, Missouri  65201
Pfizer Investigational SiteKingston, Pennsylvania  18704-5535