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

Phase 2

Completed

• Conditions: Gastrointestinal Stromal Tumors
• Interventions: Drug: Imatinib Mesylate

• Registration Number: NCT00237172
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

This is a extension study of CSTI571B1201 study

Detailed Description

Not available

Study Timeline

• Study Start: 2002-09
• Primary Completion: 2005-07
• Study First Submitted: 2005-10-09
• Study First Submitted QC: 2005-10-09
• Study First Posted: 2005-10-12
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-29
• Last Update Posted: 2012-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Patients who completed the CSTI571B1201 study

Exclusion Criteria

Other protocol-defined inclusion / exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Imatinib Mesylate	Imatinib Mesylate	400 mg once daily

Primary Outcome Measures

Name	Time	Method
To study the antineoplastic effect of the investigational drug.

Secondary Outcome Measures

Name	Time	Method
To study the safety and pharmacokinetics of the investigational drug.