NCT00171938

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2004

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

February 24, 2017

Status Verified

November 1, 2009

Enrollment Period

2.2 years

First QC Date

September 13, 2005

Last Update Submit

February 23, 2017

Conditions

Glioblastoma

Keywords

GlioblastomaBrain tumorsImatinibPDGFR

Outcome Measures

Primary Outcomes (1)

  • PFS (progression free-survival), defined by the percentage of patients without evidence of progressive disease in 6 months

Secondary Outcomes (2)

  • Objective Tumoral Response defined by RECISt criteria performed by MRI

  • OS (overall survival)

Interventions

imatinib mesylateDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically documented diagnosis of GBM.
  • Immunohistochemical documentation of expression of PDGFR.
  • Unresectable, recurrent disease by MRI and spectroscopy

You may not qualify if:

  • Treatment with any other investigational agents within 28 days of first day of study drug dosing.
  • Concurrent chemotherapy.
  • Concurrent radiotherapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Rio Grande, Brazil

Location

MeSH Terms

Conditions

GlioblastomaBrain Neoplasms

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Officials

  • Novartis

    Novartis

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

April 1, 2004

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

February 24, 2017

Record last verified: 2009-11

Locations

BR(1)