Phase II Clinical Study of Imatinib Mesylate in Patients With Malignant Gastrointestinal Stromal Tumors (Extension Study)

This study has been completed.

First Received on October 9, 2005. Last Updated on November 20, 2009 History of Changes

Sponsor:	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

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

Resource links provided by NLM:

Genetics Home Reference related topics: gastrointestinal stromal tumor

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:

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

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00237172 History of Changes
Other Study ID Numbers:	CSTI571B1202
Study First Received:	October 9, 2005
Last Updated:	November 20, 2009
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Novartis:

GIST
Imatinib
STI571
Gastrointestinal Stromal Tumors

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