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

This study has suspended participant recruitment.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00171938
First received: September 13, 2005
Last updated: November 20, 2009
Last verified: November 2009
  Purpose

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


Condition Intervention Phase
Glioblastoma
Drug: imatinib mesylate
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-label Trial of Imatinib Mesylate in Patients With Unresectable Recurrent Glioblastoma Multiforme Expressing PDGFR (Platelet Derived Growth Factor Receptors)

Resource links provided by NLM:


Further study details as provided by Novartis:

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)

Estimated Enrollment: 40
Study Start Date: April 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00171938

Locations
Brazil
Rio Grande, Brazil
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Novartis
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00171938     History of Changes
Other Study ID Numbers: CSTI571BBR03
Study First Received: September 13, 2005
Last Updated: November 20, 2009
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Novartis:
Glioblastoma
Brain tumors
Imatinib
PDGFR

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Imatinib
Mitogens
Antineoplastic Agents
Enzyme Inhibitors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014