A Study of the Efficacy and Safety of Imatinib Mesylate in Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumors Expressing c-Kit Gene

This study has been completed.

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00237185

Purpose

In the core study, patients with unresectable or metastatic gastrointerstinal stromal tumors expressing c-kit were treated with either 400 mg or 600 mg imatinib mesylate for 3 years. This 4-year extension study allows patients who successfully completed the core study to continue study treatment with imatinib mesylate.

Condition	Intervention	Phase
Unresectable or Metastatic Malignant Gastrointestinal Stromal Tumor (GIST)	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, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Study of the Efficacy and Safety of Imatinib Mesylate in Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumors Expressing c-Kit Gene

Further study details as provided by Novartis:

Primary Outcome Measures:

Overall tumor response based on SWOG response criteria

Secondary Outcome Measures:

Overall survival from the first imatinib dose to the death of the patient

Estimated Enrollment:	56
Study Start Date:	October 2003

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00237185

Locations

United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Oregon
Oregon Health Sciences University
Portland, Oregon, United States, 97201
United States, Pennsylvania
Fox Case Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Australia

Geelong, Australia
Finland

Helsinki, Finland

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis

More Information

Study ID Numbers:	CSTI571B2222E1
Study First Received:	October 9, 2005
Last Updated:	July 5, 2007
ClinicalTrials.gov Identifier:	NCT00237185
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

GIST
c-kit
imatinib mesylate

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