NCT00171938
Terminated
Phase 2
Open-label Trial of Imatinib Mesylate in Patients With Unresectable Recurrent Glioblastoma Multiforme Expressing PDGFR (Platelet Derived Growth Factor Receptors)
ConditionsGlioblastoma
Drugsimatinib mesylate
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Glioblastoma
- Sponsor
- Novartis
- Enrollment
- 30
- Primary Endpoint
- PFS (progression free-survival), defined by the percentage of patients without evidence of progressive disease in 6 months
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically documented diagnosis of GBM.
- •Immunohistochemical documentation of expression of PDGFR.
- •Unresectable, recurrent disease by MRI and spectroscopy
Exclusion Criteria
- •Treatment with any other investigational agents within 28 days of first day of study drug dosing.
- •Concurrent chemotherapy.
- •Concurrent radiotherapy.
- •Other protocol-defined exclusion criteria may apply.
Outcomes
Primary Outcomes
PFS (progression free-survival), defined by the percentage of patients without evidence of progressive disease in 6 months
Secondary Outcomes
- Objective Tumoral Response defined by RECISt criteria performed by MRI
- OS (overall survival)
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