Post-Marketing Clinical Study of Postoperative Adjuvant Therapy With Imatinib Mesylate in Patients With Gastrointestinal Stromal Tumors (GIST)

This study has been completed.

First Received on September 13, 2005. Last Updated on January 25, 2011 History of Changes

Sponsor:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00171977

Purpose

This is a multicenter, post-marketing, clinical study evaluating the safety and efficacy of postoperative adjuvant therapy with Imatinib Mesylate in high-risk patients after curative resection of newly diagnosed GIST.Patients will be evaluated for relapse -free survival as measured by the confirmation of tumor recurrence and survival for 3 years after surgery for their primary tumors.

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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Post-Marketing Clinical Study of Postoperative Adjuvant Therapy With Imatinib Mesylate in Patients With Gastrointestinal Stromal Tumors (GIST)

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 evaluate the relapse-free survival (RFS) in patients receiving postoperative adjuvant therapy [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate overall survival, relapse free [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Safety [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Enrollment:	64
Study Start Date:	July 2004
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Imatinib Mesylate 400 mg once per day	Drug: Imatinib Mesylate Other Names: Gleevec/Glivec STI571

Eligibility

Ages Eligible for Study:	20 Years to 74 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

underwent macroscopically curative resection;
immunohistochemically confirmed KIT (CD117)-positive tumors;
judged as being high-risk according to the criteria for risk classification

Exclusion Criteria:

synchronous double cancer or metachronous double cancer with a disease-free period of ≤5 years;
received therapy with Imatinib Mesylate prior to study entry;
cardiac problem of Grade 3 or higher (New York Heart Association (NYHA) criteria)

Other protocol-defined inclusion / exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00171977

Locations

Japan
Novartis Investigative Site
Tokyo, Japan

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Essat M, Cooper K. Imatinib as adjuvant therapy for gastrointestinal stromal tumors: a systematic review. Int J Cancer. 2011 May 1;128(9):2202-14.

Responsible Party:	External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00171977 History of Changes
Other Study ID Numbers:	CSTI571BJP07
Study First Received:	September 13, 2005
Last Updated:	January 25, 2011
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Novartis:

GIST
Imatinib
Postoperative Adjuvant

Additional relevant MeSH terms:

Gastrointestinal Stromal Tumors
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Adjuvants, Immunologic
Imatinib

Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012