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

Phase 2TerminatedNCT00171938

Novartis30 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Glioblastoma

Interventions

imatinib mesylateDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Unnamed facility

Rio Grande, Brazil

Outcomes

Primary Outcomes

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

Secondary Outcomes

Objective Tumoral Response defined by RECISt criteria performed by MRI

OS (overall survival)

Data from ClinicalTrials.gov

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