Back to resultsOpen-label Trial of Imatinib Mesylate in Patients With Unresectable Recurrent Glioblastoma Multiforme Expressing PDGFR (Platelet Derived Growth Factor Receptors)
Primary Purpose
Glioblastoma
Status
Terminated
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
imatinib mesylate
Sponsored by
About this trial
This is an interventional treatment trial for Glioblastoma focused on measuring Glioblastoma, Brain tumors, Imatinib, PDGFR
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.
Sites / Locations
Outcomes
Primary Outcome Measures
PFS (progression free-survival), defined by the percentage of patients without evidence of progressive disease in 6 months
Secondary Outcome Measures
Objective Tumoral Response defined by RECISt criteria performed by MRI
OS (overall survival)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00171938
Brief Title
Open-label Trial of Imatinib Mesylate in Patients With Unresectable Recurrent Glioblastoma Multiforme Expressing PDGFR (Platelet Derived Growth Factor Receptors)
Official Title
Open-label Trial of Imatinib Mesylate in Patients With Unresectable Recurrent Glioblastoma Multiforme Expressing PDGFR (Platelet Derived Growth Factor Receptors)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Terminated
Study Start Date
April 2004 (Actual)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma
Keywords
Glioblastoma, Brain tumors, Imatinib, PDGFR
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
imatinib mesylate
Primary Outcome Measure Information:
Title
PFS (progression free-survival), defined by the percentage of patients without evidence of progressive disease in 6 months
Secondary Outcome Measure Information:
Title
Objective Tumoral Response defined by RECISt criteria performed by MRI
Title
OS (overall survival)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis
Organizational Affiliation
Novartis
Official's Role
Study Chair
Facility Information:
City
Rio Grande
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Open-label Trial of Imatinib Mesylate in Patients With Unresectable Recurrent Glioblastoma Multiforme Expressing PDGFR (Platelet Derived Growth Factor Receptors)
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