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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00171938
First Posted: September 15, 2005
Last Update Posted: February 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Novartis
September 13, 2005
September 15, 2005
February 24, 2017
April 2004
June 2006   (Final data collection date for primary outcome measure)
PFS (progression free-survival), defined by the percentage of patients without evidence of progressive disease in 6 months
Not Provided
Complete list of historical versions of study NCT00171938 on ClinicalTrials.gov Archive Site
  • Objective Tumoral Response defined by RECISt criteria performed by MRI
  • OS (overall survival)
Not Provided
Not Provided
Not Provided
 
Open-label Trial of Imatinib Mesylate in Patients With Unresectable Recurrent Glioblastoma Multiforme Expressing PDGFR (Platelet Derived Growth Factor Receptors)
Open-label Trial of Imatinib Mesylate in Patients With Unresectable Recurrent Glioblastoma Multiforme Expressing PDGFR (Platelet Derived Growth Factor Receptors)
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
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Glioblastoma
Drug: imatinib mesylate
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
30
June 2006
June 2006   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT00171938
CSTI571BBR03
Not Provided
Not Provided
Not Provided
Not Provided
Novartis
Not Provided
Study Chair: Novartis Novartis
Novartis
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP