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Phase II Clinical Study of Imatinib Mesylate in Patients With Malignant Gastrointestinal Stromal Tumors (Extension Study)
This study has been completed.
Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00237172
  Purpose

This is a extension study of CSTI571B1201 study


Condition Intervention Phase
Gastrointestinal Stromal Tumors
Drug: Imatinib Mesylate
Phase II

MedlinePlus related topics: Cancer
Drug Information available for: Imatinib Imatinib mesylate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Novartis:

Primary Outcome Measures:
  • To study the antineoplastic effect of the investigational drug.

Secondary Outcome Measures:
  • To study the safety and pharmacokinetics of the investigational drug.

Estimated Enrollment: 72
Study Start Date: September 2002
  Eligibility

Ages Eligible for Study:   20 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Patients who completed the CSTI571B1201 study

Exclusion Criteria:

-

Other protocol-defined inclusion / exclusion criteria may apply.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00237172

Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Novartis
  More Information

Study ID Numbers: CSTI571B1202
Study First Received: October 9, 2005
Last Updated: May 26, 2006
ClinicalTrials.gov Identifier: NCT00237172  
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Novartis:
GIST
Imatinib
STI571
Gastrointestinal Stromal Tumors

Study placed in the following topic categories:
Imatinib
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Gastrointestinal Stromal Tumors

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009