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

Gastrointestinal Stromal Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00171977
• Other study ID #: CSTI571BJP07
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: August 6, 2012
• Start date: July 2004

Study information

• Verified date: August 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 74 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastrointestinal Stromal Tumors

Intervention

Drug:
• Imatinib Mesylate

Locations

Country	Name	City	State
Japan	Novartis Investigative Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the relapse-free survival (RFS) in patients receiving postoperative adjuvant therapy		3 years	No
Secondary	To evaluate overall survival, relapse free		3 years	No
Secondary	Safety		3 years	Yes