Study of AEE788 in Patients With Recurrent/Relapse Glioblastoma Multiforme (GBM)
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.
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AEE788 is an orally active, reversible, small-molecule, multi-targeted kinase inhibitor with potent inhibitory activity against the ErbB and VEGF receptor family of tyrosine kinases. It has an IC50 of less than 100 nM against p-EGFR, p-ErbB2, and p-KDR (VEGFR2). This study will assess the safety, pharmacokinetic/pharmacodynamic (PK/PD) profiles and clinical activity of AEE788 in a recurrent GBM population.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Histologically confirmed GBM in first or second recurrence or relapse
Adequate hematologic, hepatic and renal function
Age ≥ 18 years
Karnofsky performance status score ≥ 70%
Life expectancy ≥ 12 weeks
Peripheral neuropathy > grade 1
Diarrhea > grade 1
Compromised cardiac function
Concurrent severe and/or uncontrolled medical conditions