A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Of SU011248 In The Treatment Of Patients With Imatinib Mesylate (Gleevec Tm, Glivec)-Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Time to Tumor Progression (TTP) as Assessed by Imaging Studies at End of Double-blind Treatment Phase

Outcome Time Frame:

Day 28 of each 6-week cycle : duration of double-blind treatment phase

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:

A6181004

NCT ID:

NCT00075218

Start Date:

December 2003

Completion Date:

May 2008

Related Keywords:

• Gastrointestinal Stromal Tumor
• Gastrointestinal Stromal Tumors