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

Gastrointestinal Stromal Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00237172
• Other study ID #: CSTI571B1202
• Status: Completed
• Phase: Phase 2
• First received: October 9, 2005
• Last updated: April 29, 2012
• Start date: September 2002

Study information

• Verified date: April 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

This is a extension study of CSTI571B1201 study

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. primary completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 74 Years

Eligibility

Inclusion Criteria:

• Patients who completed the CSTI571B1201 study

Exclusion 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
once daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To study the antineoplastic effect of the investigational drug.
Secondary	To study the safety and pharmacokinetics of the investigational drug.