A 10 Year Extension to an Open, Randomized, Phase II Study of Glivec in Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumors Expressing C-kit

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall tumor response based on SWOG response criteria

Outcome Time Frame:

Until no patients are left on the study

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CSTI571B2222E1

NCT ID:

NCT00237185

Start Date:

October 2003

Completion Date:

October 2014

Related Keywords:

• Unresectable or Metastatic Malignant Gastrointestinal Stromal Tumor (GIST)
• GIST
• c-kit
• imatinib mesylate
• Gastrointestinal Stromal Tumors