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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00237172
First received: October 9, 2005
Last updated: April 29, 2012
Last verified: April 2012
  Purpose

This is a extension study of CSTI571B1201 study


Condition Intervention Phase
Gastrointestinal Stromal Tumors
Drug: Imatinib Mesylate
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Clinical Study of Imatinib Mesylate in Patients With Malignant Gastrointestinal Stromal Tumors (Extension Study)

Resource links provided by NLM:


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.

Enrollment: 72
Study Start Date: September 2002
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Imatinib Mesylate
400 mg once daily
Drug: Imatinib Mesylate
once daily
Other Name: STI571

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00237172     History of Changes
Other Study ID Numbers: CSTI571B1202
Study First Received: October 9, 2005
Last Updated: April 29, 2012
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
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System 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 August 20, 2014