Open-label Trial of Imatinib Mesylate in Patients With Unresectable Recurrent Glioblastoma Multiforme Expressing PDGFR (Platelet Derived Growth Factor Receptors)
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Glioblastoma
Both
Glioblastoma
Trial Information
Open-label Trial of Imatinib Mesylate in Patients With Unresectable Recurrent Glioblastoma Multiforme Expressing PDGFR (Platelet Derived Growth Factor Receptors)
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
PFS (progression free-survival), defined by the percentage of patients without evidence of progressive disease in 6 months
Principal Investigator
Novartis
Investigator Role:
Study Chair
Investigator Affiliation:
Novartis
Authority:
Brazil: National Health Surveillance Agency
Study ID:
CSTI571BBR03
NCT ID:
NCT00171938
Start Date:
April 2004
Completion Date:
Related Keywords:
- Glioblastoma
- Glioblastoma
- Brain tumors
- Imatinib
- PDGFR
- Glioblastoma
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