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
18 Years
N/A
Both
Gastrointestinal Stromal Tumor
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 Site | Detroit, Michigan 48201 |
| Pfizer Investigational Site | Columbia, Missouri 65201 |
| Pfizer Investigational Site | Kingston, Pennsylvania 18704-5535 |
