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
18 Years
N/A
Both
Unresectable or Metastatic Malignant Gastrointestinal Stromal Tumor (GIST)
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 Center | Philadelphia, Pennsylvania 19111 |
| Dana Farber Cancer Institute Dept of Sarcoma Oncology | Boston, Massachusetts 02115 |
| Oregon Health Sciences University Dept. of Oregon Health Sci. | Portland, Oregon 97201 |
