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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Unresectable or Metastatic Malignant Gastrointestinal Stromal Tumor (GIST)

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Trial Information

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


A 10 year extension to an open, randomized study of Glivec in patients with unresectable or
metastatic gastrointestinal stromal tumors expressing c-kit


Inclusion Criteria:



- Successful completion of the CSTI571B2222 study

- Written informed consent for the extension CSTI571B2222E1

Exclusion Criteria:

- none

Other protocol-defined inclusion / exclusion criteria may apply.

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

Name

Location

Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Dana Farber Cancer Institute Dept of Sarcoma OncologyBoston, Massachusetts  02115
Oregon Health Sciences University Dept. of Oregon Health Sci.Portland, Oregon  97201