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NCT00171938 Clinical Trial

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

Glioblastoma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00171938
Other study ID # CSTI571BBR03
Secondary ID
Status Terminated
Phase Phase 2
First received September 13, 2005
Last updated February 23, 2017
Start date April 2004
Est. completion date June 2006

Study information
Verified date November 2009
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Terminated
Enrollment 30
Est. completion date June 2006
Est. primary completion date June 2006
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• imatinib mesylate

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary PFS (progression free-survival), defined by the percentage of patients without evidence of progressive disease in 6 months
Secondary Objective Tumoral Response defined by RECISt criteria performed by MRI
Secondary OS (overall survival)
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