Study of AEE788 in Patients With Recurrent/Relapse Glioblastoma Multiforme (GBM)

Completed · Phase 1/Phase 2

Conditions studied: Glioblastoma Multiforme

In brief

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.

Key facts

Study ID

NCT00116376

Run by

Novartis Pharmaceuticals

People needed

64

Starts

2004-01-01

Expected to finish

2005-11-01

Last updated by the study team

2015-11-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Peripheral neuropathy > grade 1
• Diarrhea > grade 1
• Gastrointestinal dysfunction
• Compromised cardiac function
• Concurrent severe and/or uncontrolled medical conditions

Where it is running

• University of California at Los Angeles — Los Angeles, California, United States
• University of California, San Francisco — San Francisco, California, United States
• The Brain Tumor Center at Duke, Duke University Medical Center — Box 3624 Dumc, Trent Drive, Durham, North Carolina, United States
• University of Texas, MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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