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.

First Received on October 9, 2005. Last Updated on December 9, 2010 History of Changes

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

Genetics Home Reference related topics: gastrointestinal stromal tumor Help Me Understand Genetics

MedlinePlus related topics: Cancer

Drug Information available for: Imatinib Imatinib mesylate

U.S. FDA Resources

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

No publications provided

Responsible Party:	External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00237185 History of Changes
Other Study ID Numbers:	CSTI571B2222E1
Study First Received:	October 9, 2005
Last Updated:	December 9, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

GIST
c-kit
imatinib mesylate

Additional relevant MeSH terms:

Gastrointestinal Stromal Tumors
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases

Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012