Open-label Trial of Imatinib Mesylate in Patients With Unresectable Recurrent Glioblastoma Multiforme Expressing PDGFR (Platelet Derived Growth Factor Receptors)

Phase 2

Terminated

• Conditions: Glioblastoma

• Registration Number: NCT00171938
• Lead Sponsor: Novartis

Brief Summary

This is an open label clinical trial of imatinib mesylate 800 mg po/day in a population of patients with unresectable, recurrent glioblastoma multiforme. Patients will be treated for up to 12 months

Detailed Description

Not available

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-15
• Primary Completion: 2006-06
• Study Completion: 2006-06
• Status Verified: 2009-11
• Last Update Submitted: 2017-02-23
• Last Update Posted: 2017-02-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Histologically documented diagnosis of GBM.
2. Immunohistochemical documentation of expression of PDGFR.
3. Unresectable, recurrent disease by MRI and spectroscopy

Exclusion Criteria

1. Treatment with any other investigational agents within 28 days of first day of study drug dosing.
2. Concurrent chemotherapy.
3. Concurrent radiotherapy.

Other protocol-defined exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
PFS (progression free-survival), defined by the percentage of patients without evidence of progressive disease in 6 months

Secondary Outcome Measures

Name	Time	Method
Objective Tumoral Response defined by RECISt criteria performed by MRI
OS (overall survival)