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 is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00237185
First received: October 9, 2005
Last updated: May 31, 2013
Last verified: May 2013
  Purpose

In the core study, patients with unresectable or metastatic gastrointestinal 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 2

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:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Overall tumor response based on SWOG response criteria [ Time Frame: Until no patients are left on the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: from the first imatinib dose to the death of the patient ] [ Designated as safety issue: No ]

Estimated Enrollment: 55
Study Start Date: October 2003
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 400 mg imatinib mesylate Drug: Imatinib mesylate
Experimental: 600 mg imatinib mesylate Drug: Imatinib mesylate

Detailed Description:

A 10 year extension to an open, randomized study of Glivec in patients with unresectable or metastatic gastrointestinal stromal tumors expressing c-kit

  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 Dept of Sarcoma Oncology
Boston, Massachusetts, United States, 02115
United States, Oregon
Oregon Health Sciences University Dept. of Oregon Health Sci.
Portland, Oregon, United States, 97201
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Australia, Victoria
Novartis Investigative Site
Geelong, Victoria, Australia, 3220
Finland
Novartis Investigative Site
Helsinki, Finland, FIN-00029
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Study Chair: Novartis Novartis
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00237185     History of Changes
Other Study ID Numbers: CSTI571B2222E1
Study First Received: October 9, 2005
Last Updated: May 31, 2013
Health Authority: United States: Food and Drug Administration
Finland: Finnish Medicines Agency

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 April 14, 2014